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    Clinical Trial Results:
    Phase 1/2/3, Placebo-Controlled, Randomized, Observer-Blind, Dose-Finding Study To Evaluate The Safety, Tolerability, Immunogenicity, And Efficacy Of Sars-Cov-2 RNA Vaccine Candidates Against Covid-19 In Healthy Individuals

    Summary
    EudraCT number
    		 2020-002641-42
    Trial protocol
    		 DE  
    Global end of trial date
    10 Feb 2023

    Results information
    Results version number
    		 v1
    This version publication date
    26 Aug 2023
    First version publication date
    26 Aug 2023
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    C4591001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04368728
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    BioNTech SE
    Sponsor organisation address
    An der Goldgrube 12, Mainz, Germany, 55131
    Public contact
    BioNTech clinical trials patient information, BioNTech SE, 49 6131 90840, patients@biontech.de
    Scientific contact
    BioNTech clinical trials patient information, BioNTech SE, 49 6131 90840, patients@biontech.de
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002861-PIP02-20
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    28 Apr 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Feb 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Phase 1: To describe safety and tolerability profiles of prophylactic BNT162 vaccines in healthy adults after 1 or 2 doses. Phase 2/3: To evaluate efficacy of prophylactic BNT162b2 against confirmed COVID-19 occurring from 7 days after second dose in subjects without evidence of infection before vaccination and in subjects with or without evidence of infection before vaccination; To define the safety profile of prophylactic BNT162b2 in the first 360 subjects randomized (Phase 2), all subjects randomized (Phase 2/3); and subjects 12 to 15 years of age (Phase 3); To demonstrate noninferiority of anti–reference strain immune response after a third dose of BNT162b2 at 30 μg compared to after 2 doses of BNT162b2, in the same individuals; To demonstrate noninferiority of anti-SA immune response after 1 dose (BNT162b2-experienced) or 2 doses (BNT162b2-naïve) of BNT162b2SA compared to anti–reference strain immune response after 2 doses of BNT162b2, in the same individuals.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Apr 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 5775
    Country: Number of subjects enrolled
    Brazil: 2898
    Country: Number of subjects enrolled
    Germany: 500
    Country: Number of subjects enrolled
    South Africa: 800
    Country: Number of subjects enrolled
    Turkey: 500
    Country: Number of subjects enrolled
    United States: 36461
    Worldwide total number of subjects
    46934
    EEA total number of subjects
    500
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    3019
    Adults (18-64 years)
    34709
    From 65 to 84 years
    9164
    85 years and over
    42

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study consisted of 2 parts. Overall period was created to support display of the demographic characteristics for all study phases and the complete disposition information for each individual phase is presented, in separate tables, below.

    Pre-assignment
    Screening details
    		 A total of 46934 subjects were randomised and assigned to the treatment. The study consisted of 2 parts. Phase 1: to identify preferred vaccine candidate and dose level of candidate vaccine; Phase 2/3: an expanded cohort and efficacy part.

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Phase 1: BNT162b1 10 mcg dose: 18-85 years of age
    Arm description
    		 Subjects aged 18-85 years were randomised to receive 2 doses of 10 microgram (mcg) BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10 mcg: 250 mcg/0.5 mL

    Arm title
    		 Phase 1: BNT162b1 20 mcg dose:18-85 years of age
    Arm description
    		 Subjects aged 18-85 years were randomised to receive 2 doses of 20 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    20 mcg: 250 mcg/0.5 mL

    Arm title
    		 Phase 1: BNT162b1 30 mcg dose:18-85 years of age
    Arm description
    		 Subjects aged 18-85 years were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 mcg: 250 mcg/0.5 mL

    Arm title
    		 Phase 1: BNT162b1 100 mcg dose:18-85 years of age
    Arm description
    		 Subjects aged 18-55 years were randomised to receive 2 doses of 100 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly and received only 1 dose due to reactogenicity.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    100 mcg: 250 mcg/0.5 mL

    Arm title
    		 Phase 1: Placebo: 18-55 Years of Age
    Arm description
    		 Subjects were originally randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Normal saline (0.9% sodium chloride solution for injection)

    Arm title
    		 Phase 1: BNT162b2 10 mcg dose: 18-85 years of age
    Arm description
    		 Subjects aged 18-85 years were randomised to receive 2 doses of 10 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10 mcg: 250 mcg/0.5 mL

    Arm title
    		 Phase 1: BNT162b2 20 mcg dose: 18-85 years of age
    Arm description
    		 Subjects aged 18-85 years were randomised to receive 2 doses of 20 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    20 mcg: 250 mcg/0.5 mL

    Arm title
    		 Phase 1: BNT162b2 30 mcg dose: 18-85 years of age
    Arm description
    		 Subjects aged 18-85 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 mcg: 250 mcg/0.5 mL

    Arm title
    		 Phase 2/3: BNT162b2 (30mcg): 12-15 years of age
    Arm description
    		 Subjects aged 12-15 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 mcg: 250 mcg/0.5 mL

    Arm title
    		 Phase 2/3: Placebo: 12-15 years of age
    Arm description
    		 Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Normal saline (0.9% sodium chloride solution for injection)

    Arm title
    		 Phase 2/3: BNT162b2 (30 mcg): >=16 years of age
    Arm description
    		 Subjects randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 mcg: 250 mcg/0.5 mL

    Arm title
    		 Phase 2/3: Placebo: >=16 years of age
    Arm description
    		 Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Normal saline (0.9% sodium chloride solution for injection)

    Arm title
    		 Phase 3: BNT162b2 SA 30 mcg Single Booster Dose
    Arm description
    		 Subjects randomised to receive 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2 SA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 mcg: 250 mcg/0.5 milliliter

    Number of subjects in period 1
    		Phase 1: BNT162b1 10 mcg dose: 18-85 years of age Phase 1: BNT162b1 20 mcg dose:18-85 years of age Phase 1: BNT162b1 30 mcg dose:18-85 years of age Phase 1: BNT162b1 100 mcg dose:18-85 years of age Phase 1: Placebo: 18-55 Years of Age Phase 1: BNT162b2 10 mcg dose: 18-85 years of age Phase 1: BNT162b2 20 mcg dose: 18-85 years of age Phase 1: BNT162b2 30 mcg dose: 18-85 years of age Phase 2/3: BNT162b2 (30mcg): 12-15 years of age Phase 2/3: Placebo: 12-15 years of age Phase 2/3: BNT162b2 (30 mcg): >=16 years of age Phase 2/3: Placebo: >=16 years of age Phase 3: BNT162b2 SA 30 mcg Single Booster Dose
    Started
    24
    24
    24
    12
    39
    24
    24
    24
    1134
    1130
    22071
    22071
    333
    Completed
    24
    24
    24
    12
    39
    24
    24
    24
    1134
    1130
    22071
    22071
    333
    Period 2
    Period 2 title
    Phase 1
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Phase 1:BNT162b1 10 mcg dose: 18-85 years of age (2 doses)
    Arm description
    		 Subjects aged 18-85 years were randomised to receive 2 doses of 10 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10 mcg: 250 mcg/0.5 mL

    Arm title
    		 Phase 1:BNT162b1 20 mcg dose:18-85 years of age (2 doses)
    Arm description
    		 Subjects aged 18-85 years were randomised to receive 2 doses of 20 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    20 mcg: 250 mcg/0.5 mL

    Arm title
    		 Phase 1:BNT162b1 30 mcg dose:18-85 years of age (2 doses)
    Arm description
    		 Subjects aged 18-85 years were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 mcg: 250 mcg/0.5 mL

    Arm title
    		 Phase 1:BNT162b1 100 mcg dose:18-85 years of age (2 doses)
    Arm description
    		 Subjects aged 18-85 years were randomised to receive 1 dose of 100 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    100 mcg: 250 mcg/0.5 mL

    Arm title
    		 Phase 1: Placebo: 18-85 Years of Age
    Arm description
    		 Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.
    Arm type
    		 Placebo

    Investigational medicinal product name
    BNT162b1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Normal saline (0.9% sodium chloride solution for injection)

    Arm title
    		 Phase 1: BNT162b2: 10 mcg dose: 18-85 years of age
    Arm description
    		 Subjects aged 18-85 years were randomised to receive 2 doses of 10 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    10 mcg: 250 mcg/0.5 mL

    Arm title
    		 Phase 1: BNT162b2: 20 mcg dose: 18-55 years of age
    Arm description
    		 Subjects aged 18-55 years were randomised to receive 2 doses of 20 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    20 mcg: 250 mcg/0.5 mL

    Arm title
    		 Phase 1: BNT162b2: 30 mcg dose: 18-85 years of age
    Arm description
    		 Subjects aged 18-85 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 mcg: 250 mcg/0.5 mL

    Number of subjects in period 2
    		Phase 1:BNT162b1 10 mcg dose: 18-85 years of age (2 doses) Phase 1:BNT162b1 20 mcg dose:18-85 years of age (2 doses) Phase 1:BNT162b1 30 mcg dose:18-85 years of age (2 doses) Phase 1:BNT162b1 100 mcg dose:18-85 years of age (2 doses) Phase 1: Placebo: 18-85 Years of Age Phase 1: BNT162b2: 10 mcg dose: 18-85 years of age Phase 1: BNT162b2: 20 mcg dose: 18-55 years of age Phase 1: BNT162b2: 30 mcg dose: 18-85 years of age
    Started
    24
    24
    24
    12
    39
    24
    24
    24
    Completed
    14
    18
    13
    8
    23
    20
    19
    16
    Not completed
    10
    6
    11
    4
    16
    4
    5
    8
         Consent withdrawn by subject
    -
    1
    2
    -
    1
    -
    -
    -
         No longer meets eligibility criteria
    5
    -
    5
    1
    7
    3
    1
    4
         Unspecified
    -
    -
    -
    -
    2
    1
    1
    1
         Lost to follow-up
    -
    -
    -
    1
    -
    -
    -
    1
         Protocol deviation
    5
    5
    4
    2
    6
    -
    3
    2
    Period 3
    Period 3 title
    Phase 2/3: Blinded Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Phase 2/3: BNT162b2 (30 mcg): 12-15 Years
    Arm description
    		 Subjects aged 12-15 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 mcg: 250 mcg/0.5 mL

    Arm title
    		 Phase 2/3: Placebo 12-15 Years
    Arm description
    		 Subjects aged 12-15 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Normal saline (0.9% sodium chloride solution for injection)

    Arm title
    		 Phase 2/3: BNT162b2 (30 mcg): >=16 years of age
    Arm description
    		 Subjects aged greater than or equal to 16 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 mcg: 250 mcg/0.5 mL

    Arm title
    		 Phase 2/3: Placebo for >=16 years of age
    Arm description
    		 Subjects aged greater than or equal to 16 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Normal saline (0.9% sodium chloride solution for injection)

    Number of subjects in period 3
    		Phase 2/3: BNT162b2 (30 mcg): 12-15 Years Phase 2/3: Placebo 12-15 Years Phase 2/3: BNT162b2 (30 mcg): >=16 years of age Phase 2/3: Placebo for >=16 years of age
    Started
    1134
    1130
    22071
    22071
    Completed
    3
    2
    21
    37
    Not completed
    1131
    1128
    22050
    22034
         Physician decision
    -
    -
    5
    7
         Subjects entered open label period
    1119
    1110
    21500
    21351
         Withdrawal by parent/guardian
    1
    5
    1
    -
         Consent withdrawn by subject
    1
    7
    139
    250
         No longer meets eligibility criteria
    -
    2
    16
    21
         Adverse event, non-fatal
    -
    -
    9
    9
         Death
    -
    -
    18
    16
         Refused further study procedures
    -
    -
    2
    -
         Medication error without associated adverse event
    -
    -
    1
    -
         Pregnancy
    -
    -
    -
    1
         Unspecified
    3
    1
    33
    11
         Randomised but not vaccinated
    3
    1
    55
    48
         Lost to follow-up
    4
    2
    256
    281
         Protocol deviation
    -
    -
    15
    39
    Period 4
    Period 4 title
    Phase 2/3: Open label
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Phase 2/3: BNT162b2 (30 mcg): 12-15 Years
    Arm description
    		 Subjects aged 12-15 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 mcg: 250 microgram/0.5 milliliter

    Arm title
    		 Phase2/3: Placebo 12-15 Years
    Arm description
    		 Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Normal saline (0.9% sodium chloride solution for injection)

    Arm title
    		 Phase 2/3: BNT162b2 (30 mcg) >=16 years of age
    Arm description
    		 Subjects aged >=16 years of age were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 mcg: 250 microgram/0.5 milliliter

    Arm title
    		 Phase 2/3: Placebo
    Arm description
    		 Subjects aged >=16 years of age were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Normal saline (0.9% sodium chloride solution for injection)

    Number of subjects in period 4
    		Phase 2/3: BNT162b2 (30 mcg): 12-15 Years Phase2/3: Placebo 12-15 Years Phase 2/3: BNT162b2 (30 mcg) >=16 years of age Phase 2/3: Placebo
    Started
    1119
    1110
    21500
    21351
    Completed
    560
    661
    6954
    10428
    Not completed
    559
    449
    14546
    10923
         Consent withdrawn by subject
    49
    52
    1500
    1792
         Physician decision
    -
    -
    35
    31
         No longer meets eligibility criteria
    107
    114
    940
    1580
         Adverse event, non-fatal
    -
    -
    4
    6
         Death
    -
    1
    67
    68
         Pregnancy
    -
    -
    1
    2
         Refused further study procedure
    -
    -
    7
    12
         Unspecified
    293
    173
    9647
    3608
         Lost to follow-up
    59
    55
    1089
    1402
         Withdrawal by parent/guardian
    14
    19
    2
    -
         Protocol deviation
    37
    35
    1254
    2422
    Period 5
    Period 5 title
    Phase 3: BNT162b2-Naïve Subjects
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Phase 3: BNT162b2 SA 30 mcg >=16 years of age
    Arm description
    		 Subjects aged >=16 years received 30 microgram BNT162b2 SA vaccine (250 microgram/0.5 milliliter) intramuscularly.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BNT162b2 SA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    30 mcg: 250 microgram/0.5 milliliter

    Number of subjects in period 5
    		Phase 3: BNT162b2 SA 30 mcg >=16 years of age
    Started
    333
    Completed
    228
    Not completed
    105
         Consent withdrawn by subject
    19
         No longer meets eligibility criteria
    8
         Adverse event, non-fatal
    1
         Unspecified
    24
         Lost to follow-up
    50
         Protocol deviation
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Phase 1: BNT162b1 10 mcg dose: 18-85 years of age
    Reporting group description
    		 Subjects aged 18-85 years were randomised to receive 2 doses of 10 microgram (mcg) BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 1: BNT162b1 20 mcg dose:18-85 years of age
    Reporting group description
    		 Subjects aged 18-85 years were randomised to receive 2 doses of 20 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 1: BNT162b1 30 mcg dose:18-85 years of age
    Reporting group description
    		 Subjects aged 18-85 years were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 1: BNT162b1 100 mcg dose:18-85 years of age
    Reporting group description
    		 Subjects aged 18-55 years were randomised to receive 2 doses of 100 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly and received only 1 dose due to reactogenicity.

    Reporting group title
    Phase 1: Placebo: 18-55 Years of Age
    Reporting group description
    		 Subjects were originally randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Reporting group title
    Phase 1: BNT162b2 10 mcg dose: 18-85 years of age
    Reporting group description
    		 Subjects aged 18-85 years were randomised to receive 2 doses of 10 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 1: BNT162b2 20 mcg dose: 18-85 years of age
    Reporting group description
    		 Subjects aged 18-85 years were randomised to receive 2 doses of 20 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 1: BNT162b2 30 mcg dose: 18-85 years of age
    Reporting group description
    		 Subjects aged 18-85 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 2/3: BNT162b2 (30mcg): 12-15 years of age
    Reporting group description
    		 Subjects aged 12-15 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 2/3: Placebo: 12-15 years of age
    Reporting group description
    		 Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Reporting group title
    Phase 2/3: BNT162b2 (30 mcg): >=16 years of age
    Reporting group description
    		 Subjects randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 2/3: Placebo: >=16 years of age
    Reporting group description
    		 Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Reporting group title
    Phase 3: BNT162b2 SA 30 mcg Single Booster Dose
    Reporting group description
    		 Subjects randomised to receive 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly.

    Reporting group values
    		 Phase 1: BNT162b1 10 mcg dose: 18-85 years of age Phase 1: BNT162b1 20 mcg dose:18-85 years of age Phase 1: BNT162b1 30 mcg dose:18-85 years of age Phase 1: BNT162b1 100 mcg dose:18-85 years of age Phase 1: Placebo: 18-55 Years of Age Phase 1: BNT162b2 10 mcg dose: 18-85 years of age Phase 1: BNT162b2 20 mcg dose: 18-85 years of age Phase 1: BNT162b2 30 mcg dose: 18-85 years of age Phase 2/3: BNT162b2 (30mcg): 12-15 years of age Phase 2/3: Placebo: 12-15 years of age Phase 2/3: BNT162b2 (30 mcg): >=16 years of age Phase 2/3: Placebo: >=16 years of age Phase 3: BNT162b2 SA 30 mcg Single Booster Dose Total
    Number of subjects
    		 24 24 24 12 39 24 24 24 1134 1130 22071 22071 333 46934
    Age Categorical
    Units: Subjects
        <=18 years
    		 0 0 0 0 0 0 0 0 1134 1130 378 377 0 3019
        Between 18 and 65 years
    		 12 12 12 12 21 12 12 12 0 0 17130 17141 333 34709
        >=65 years
    		 12 12 12 0 18 12 12 12 0 0 4563 4553 0 9206
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 49.5 ( 21.36 ) 57.7 ( 14.76 ) 52.9 ( 18.88 ) 38.3 ( 9.34 ) 51.0 ( 19.18 ) 52.4 ( 18.13 ) 54.3 ( 18.87 ) 52.9 ( 17.46 ) 13.6 ( 1.11 ) 13.6 ( 1.11 ) 49.7 ( 15.99 ) 49.6 ( 16.06 ) 35.7 ( 10.72 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 13 11 14 7 22 17 13 15 564 544 10724 10952 160 23056
        Male
    		 11 13 10 5 17 7 11 9 570 586 11347 11119 173 23878
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 1 0 1 0 1 1 1 0 132 130 5716 5710 42 11735
        Not Hispanic or Latino
    		 23 24 22 12 38 23 23 24 1000 997 16281 16261 288 35016
        Unknown or Not Reported
    		 0 0 1 0 0 0 0 0 2 3 74 100 3 183
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0 0 0 0 4 3 222 217 0 446
        Asian
    		 3 0 4 1 1 1 0 2 72 71 951 947 26 2079
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0 0 0 3 0 53 31 0 87
        Black or African American
    		 1 2 0 0 0 0 2 1 52 57 2098 2121 40 4374
        White
    		 20 22 20 11 38 23 22 21 973 963 18090 18103 261 38567
        More than one race
    		 0 0 0 0 0 0 0 0 24 29 580 540 4 1177
        Unknown or Not Reported
    		 0 0 0 0 0 0 0 0 6 7 77 112 2 204

    End points

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    End points reporting groups
    Reporting group title
    Phase 1: BNT162b1 10 mcg dose: 18-85 years of age
    Reporting group description
    		 Subjects aged 18-85 years were randomised to receive 2 doses of 10 microgram (mcg) BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 1: BNT162b1 20 mcg dose:18-85 years of age
    Reporting group description
    		 Subjects aged 18-85 years were randomised to receive 2 doses of 20 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 1: BNT162b1 30 mcg dose:18-85 years of age
    Reporting group description
    		 Subjects aged 18-85 years were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 1: BNT162b1 100 mcg dose:18-85 years of age
    Reporting group description
    		 Subjects aged 18-55 years were randomised to receive 2 doses of 100 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly and received only 1 dose due to reactogenicity.

    Reporting group title
    Phase 1: Placebo: 18-55 Years of Age
    Reporting group description
    		 Subjects were originally randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Reporting group title
    Phase 1: BNT162b2 10 mcg dose: 18-85 years of age
    Reporting group description
    		 Subjects aged 18-85 years were randomised to receive 2 doses of 10 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 1: BNT162b2 20 mcg dose: 18-85 years of age
    Reporting group description
    		 Subjects aged 18-85 years were randomised to receive 2 doses of 20 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 1: BNT162b2 30 mcg dose: 18-85 years of age
    Reporting group description
    		 Subjects aged 18-85 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 2/3: BNT162b2 (30mcg): 12-15 years of age
    Reporting group description
    		 Subjects aged 12-15 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 2/3: Placebo: 12-15 years of age
    Reporting group description
    		 Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Reporting group title
    Phase 2/3: BNT162b2 (30 mcg): >=16 years of age
    Reporting group description
    		 Subjects randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 2/3: Placebo: >=16 years of age
    Reporting group description
    		 Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Reporting group title
    Phase 3: BNT162b2 SA 30 mcg Single Booster Dose
    Reporting group description
    		 Subjects randomised to receive 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly.
    Reporting group title
    Phase 1:BNT162b1 10 mcg dose: 18-85 years of age (2 doses)
    Reporting group description
    		 Subjects aged 18-85 years were randomised to receive 2 doses of 10 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 1:BNT162b1 20 mcg dose:18-85 years of age (2 doses)
    Reporting group description
    		 Subjects aged 18-85 years were randomised to receive 2 doses of 20 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 1:BNT162b1 30 mcg dose:18-85 years of age (2 doses)
    Reporting group description
    		 Subjects aged 18-85 years were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 1:BNT162b1 100 mcg dose:18-85 years of age (2 doses)
    Reporting group description
    		 Subjects aged 18-85 years were randomised to receive 1 dose of 100 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly.

    Reporting group title
    Phase 1: Placebo: 18-85 Years of Age
    Reporting group description
    		 Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Reporting group title
    Phase 1: BNT162b2: 10 mcg dose: 18-85 years of age
    Reporting group description
    		 Subjects aged 18-85 years were randomised to receive 2 doses of 10 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 1: BNT162b2: 20 mcg dose: 18-55 years of age
    Reporting group description
    		 Subjects aged 18-55 years were randomised to receive 2 doses of 20 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 1: BNT162b2: 30 mcg dose: 18-85 years of age
    Reporting group description
    		 Subjects aged 18-85 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
    Reporting group title
    Phase 2/3: BNT162b2 (30 mcg): 12-15 Years
    Reporting group description
    		 Subjects aged 12-15 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 2/3: Placebo 12-15 Years
    Reporting group description
    		 Subjects aged 12-15 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Reporting group title
    Phase 2/3: BNT162b2 (30 mcg): >=16 years of age
    Reporting group description
    		 Subjects aged greater than or equal to 16 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 2/3: Placebo for >=16 years of age
    Reporting group description
    		 Subjects aged greater than or equal to 16 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.
    Reporting group title
    Phase 2/3: BNT162b2 (30 mcg): 12-15 Years
    Reporting group description
    		 Subjects aged 12-15 years were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase2/3: Placebo 12-15 Years
    Reporting group description
    		 Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Reporting group title
    Phase 2/3: BNT162b2 (30 mcg) >=16 years of age
    Reporting group description
    		 Subjects aged >=16 years of age were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Reporting group title
    Phase 2/3: Placebo
    Reporting group description
    		 Subjects aged >=16 years of age were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.
    Reporting group title
    Phase 3: BNT162b2 SA 30 mcg >=16 years of age
    Reporting group description
    		 Subjects aged >=16 years received 30 microgram BNT162b2 SA vaccine (250 microgram/0.5 milliliter) intramuscularly.

    Subject analysis set title
    BNT162b1 10 mcg dose: 18-55 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 10 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    BNT162b1 20 mcg dose: 18-55 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 20 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    BNT162b1 30 mcg dose: 18-55 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    BNT162b1 100 mcg dose, 18-55 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 1 dose of 100 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly.

    Subject analysis set title
    Placebo 18-55 Years of Age for BNT162b1 100 mcg
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were originally randomised to receive 0.9% sodium chloride solution for Injection intramuscularly but received two doses of BNT162b2 (30 mcg) in the open-label vaccination period.

    Subject analysis set title
    BNT162b2 10 mcg dose, 18-55 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 2 doses of 10 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 20 mcg dose, 18-55 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    BNT162b2 30 mcg dose, 18-55 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg): >=16 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    10 mcg dose, 18-55 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 2 doses of 10 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    20 mcg dose, 18-55 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 2 doses of 20 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    30 mcg dose, 18-55 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    Placebo: 18-55 years of age for BNT162b1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo 100 µg Dose, 18-55 Years of Age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    10 mcg dose, 18-55 years of age B2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 2 doses of 10 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    20 mcg dose, 18-55 years of age B2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 2 doses of 20 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    30 mcg dose, 18-55 years of age B2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b1 10 mcg dose, 65-85 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 65-85 years were randomised to receive 10 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    BNT162b1 20 mcg dose, 65-85 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 65-85 years were randomised to receive 20 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    BNT162b1 30 mcg dose, 65-85 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 65-85 years were randomised to receive 30 microgram BNT162b2 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    Placebo, 65-85 years of age for BNT162b1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for injection intramuscularly.

    Subject analysis set title
    BNT162b2 10 mcg dose, 65-85 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 65-85 years were randomised to receive 10 microgram BNT162b2 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    BNT162b2 20 mcg dose, 65-85 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 65-85 years were randomised to receive 20 microgram BNT162b2 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    BNT162b2 30 mcg dose, 65-85 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 65-85 years were randomised to receive 30 microgram BNT162b2 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    30 mcg dose, 18-55 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    BNT162b1 10 mcg dose, 65-85 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 65-85 years were randomised to receive 10 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    BNT162b1 10 mcg dose, 18-85 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 18-85 years were randomised to receive 10 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    BNT162b1 20 mcg dose, 18-85 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 18-85 years were randomised to receive 20 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    BNT162b1 30 mcg dose, 18-85 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 18-85 years were randomised to receive 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    Placebo, 18-55 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo, 18-55 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    100 mcg dose, 18-55 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 1 dose of 100 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly.

    Subject analysis set title
    BNT162b2 (30 mcg): 18-55 Years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg): 65-85 Years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 65-85 years were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    Placebo:18-55 Years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo: 56 to 85 Years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    BNT162b2 (30 mcg): 18-55 Years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 30 microgram BNT162b2 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    BNT162b2 (30 mcg): 56-85 Years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 56-85 were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    Placebo:18-55 Years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo: 56 to 85 Years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo: 56-85 Years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo: 18-85 Years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo: 56-85 Years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo: 18-55 Years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo, 18-55 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    BNT162b2 (30 mcg): 16-55 Years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg): 56-85 Years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    Placebo:16-55 Years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for injection intramuscularly.

    Subject analysis set title
    Placebo: 56 to 85 Years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for injection intramuscularly.

    Subject analysis set title
    BNT162b2 (30 mcg): 16-55 Years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg): 56-85 Years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    Placebo:16-55 Years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo: 56 to 85 Years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for injection intramuscularly.

    Subject analysis set title
    BNT162b2 (30 mcg): 18-55 Years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    Placebo: 18-85 Years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo: 56-85 Years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    BNT162b2 (30 mcg): 18-55 Years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 30 microgram BNT162b2 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    Placebo: 18-85 Years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo: 56-85 Years
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    BNT162b2 (30 mcg): >=16 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2SA (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2SA (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2SA (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2SA (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2SA (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2SA (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2SA (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2SA (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    10 mcg dose, 18-55 years of age B2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 2 doses of 10 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b1 10 mcg dose, 65-85 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects of 65 to 85 years of age who originally received placebo were eligible to receive 2 booster doses of 10 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval.

    Subject analysis set title
    30 mcg dose, 65-85 years of age B2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    Placebo: 18-55 years of age for BNT162b1
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for injection intramuscularly.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg): Reference Strain
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2SA (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2SA 30 mcg
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2SA (30 mcg): SA variant
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg): Reference Strain
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2SA 30 mcg
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2SA (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 μg): Reference Strain
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 μg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 SA (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg): Reference Strain
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2SA (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    BNT162b2 (30mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b1 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    BNT162b2 (30 mcg)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 2 doses of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo: 65-85 years of age for BNT162b2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo: 18-55 years of age for BNT162b2
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    BNT162b2 10 mcg dose, 18-85 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 10 microgram BNT162b2 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    BNT162b2 20 mcg dose, 18-85 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 20 microgram BNT162b2 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    BNT162b2 30 mcg dose, 18-85 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 30 microgram BNT162b2 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    BNT162b1 100 mcg: 18-85 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 18-55 years were randomised to receive 1 dose of 100 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly.

    Subject analysis set title
    Placebo/BNT162b2 30 mcg: 18-85 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    BNT162b2 (30 mcg): 12-15 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 30 microgram BNT162b2 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    Placebo: 12-15 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo: >=16 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    Placebo/BNT162b2 30 mcg: 12-15 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    BNT162b2 30 mcg: >=16 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 30 microgram BNT162b2 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    Placebo/BNT162b2 30 mcg: >=16 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 30 microgram BNT162b2 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Subject analysis set title
    Placebo: >=16 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects were randomised to receive 0.9% sodium chloride solution for Injection intramuscularly.

    Subject analysis set title
    BNT162b2 (30 mcg): 16-25 years of age
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects aged 16-25 years were randomised to receive 30 microgram BNT162b2 vaccine 250 microgram/0.5 milliliter intramuscularly for Visit 1 and Visit 4.

    Primary: Percentage of Subjects With Local Reactions Within 7 Days After Dose 1: Phase 1

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    End point title
    		 Percentage of Subjects With Local Reactions Within 7 Days After Dose 1: Phase 1 [1]
    End point description
    Local reactions included redness, swelling and, pain at the injection site, recorded by subjects in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than [>] 2.0 to 5.0 centimeter [cm]), moderate (> 5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalisation for severe pain). Safety population included all randomised subjects who received at least 1 dose of the study intervention. 'Number of Subjects Analysed’ signifies the subject was in the safety population and had e-diary data after Dose 1. HIV positive subjects were excluded from this analysis.
    End point type
    Primary
    End point timeframe
    Within 7 days after dose 1
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis performed for this endpoint
    End point values
    		 BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    9
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
    number (confidence interval 95%)
        Redness: Mild
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    33.3 (9.9 to 65.1)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Redness: Moderate
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Redness: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Redness: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Swelling: Mild
    0 (0.0 to 26.5)
    16.7 (2.1 to 48.4)
    8.3 (0.2 to 38.5)
    25.0 (5.5 to 57.2)
    0 (0.0 to 70.8)
    16.7 (2.1 to 48.4)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Swelling: Moderate
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.8)
    16.7 (2.1 to 48.4)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Swelling: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Swelling: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Pain at injection site: Mild
    58.3 (27.7 to 84.8)
    50.0 (21.1 to 78.9)
    41.7 (15.2 to 72.3)
    33.3 (9.9 to 65.1)
    66.7 (9.4 to 99.2)
    58.3 (27.7 to 84.8)
    50.0 (21.1 to 78.9)
    75.0 (42.8 to 94.5)
    0 (0.0 to 33.6)
    58.3 (27.7 to 84.8)
    83.3 (51.6 to 97.9)
    66.7 (34.9 to 90.1)
    11.1 (0.3 to 48.2)
    33.3 (9.9 to 65.1)
    58.3 (27.7 to 84.8)
    75.0 (42.8 to 94.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Pain at injection site: Moderate
    0 (0.0 to 26.5)
    25.0 (5.5 to 57.2)
    58.3 (27.7 to 84.8)
    58.3 (27.7 to 84.8)
    0 (0.0 to 70.8)
    8.3 (0.2 to 38.5)
    16.7 (2.1 to 48.4)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    25.0 (5.5 to 57.2)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Pain at injection site: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Pain at injection site: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Local Reactions Within 7 Days After Dose 2: Phase 1

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    End point title
    		 Percentage of Subjects With Local Reactions Within 7 Days After Dose 2: Phase 1 [2]
    End point description
    Local reactions included redness, swelling and, pain at the injection site, recorded by subjects in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than [>] 2.0 to 5.0 centimeter [cm]), moderate (> 5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalisation for severe pain). Safety population included all randomised subjects who received at least 1 dose of the study intervention. 'Number of Subjects Analysed’ signifies the subject was in the safety population and had e-diary data after Dose 2 . HIV positive subjects were excluded from this analysis.
    End point type
    Primary
    End point timeframe
    Within 7 days after dose 2
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis performed for this endpoint
    End point values
    		 BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
    number (confidence interval 95%)
        Redness: Mild
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Redness: Moderate
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Redness: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Redness: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Swelling: Mild
    0 (0.0 to 26.5)
    16.7 (2.1 to 48.4)
    8.3 (0.2 to 38.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Swelling: Moderate
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Swelling: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Swelling: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Pain at injection site: Mild
    58.3 (27.7 to 84.8)
    50.0 (21.1 to 78.9)
    41.7 (15.2 to 72.3)
    58.3 (27.7 to 84.8)
    50.0 (21.1 to 78.9)
    75.0 (42.8 to 94.5)
    0 (0.0 to 33.6)
    58.3 (27.7 to 84.8)
    83.3 (51.6 to 97.9)
    66.7 (34.9 to 90.1)
    11.1 (0.3 to 48.2)
    33.3 (9.9 to 65.1)
    58.3 (27.7 to 84.8)
    75.0 (42.8 to 94.5)
    11.1 (0.3 to 48.2)
    22.2 (2.8 to 60.0)
        Pain at injection site: Moderate
    0 (0.0 to 26.5)
    25.0 (5.5 to 57.2)
    58.3 (27.7 to 84.8)
    8.3 (0.2 to 38.5)
    16.7 (2.1 to 48.4)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    25.0 (5.5 to 57.2)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Pain at injection site: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Pain at injection site: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Systemic Events Within 7 Days After Dose 1: Phase 1

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    End point title
    		 Percentage of Subjects With Systemic Events Within 7 Days After Dose 1: Phase 1 [3]
    End point description
    Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by subjects using e-diary. Fever=temperature >=38.0 degrees C categorised as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0-degrees C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalisation). Vomiting: mild (1-2 times in 24 hours[h]), moderate (more than 2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalisation for hypotensive shock). Diarrhea:mild (2 to 3 loose stools in 24h), moderate (4 to 5 loose stools in 24 h), severe (6 or more loose stools in 24 h) and Grade 4 (emergency room visit/hospitalisation). Safety population assessed.
    End point type
    Primary
    End point timeframe
    Within 7 Days After Dose 2
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis performed for this endpoint
    End point values
    		 BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
    number (confidence interval 95%)
        Fever: 38.0°C to 38.4°C
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    33.3 (9.9 to 65.1)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Fever: >38.4°C to 38.9°C
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Fever: >38.9°C to 40.0°C
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Fever: >40.0°C
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Fatigue: Mild
    25.0 (5.5 to 57.2)
    41.7 (15.2 to 72.3)
    25.0 (5.5 to 57.2)
    16.7 (2.1 to 48.4)
    33.3 (0.8 to 90.6)
    25.0 (5.5 to 57.2)
    33.3 (9.9 to 65.1)
    16.7 (2.1 to 48.4)
    11.1 (0.3 to 48.2)
    16.7 (2.1 to 48.4)
    41.7 (15.2 to 72.3)
    16.7 (2.1 to 48.4)
    33.3 (7.5 to 70.1)
    8.3 (0.2 to 38.5)
    33.3 (9.9 to 65.1)
    16.7 (2.1 to 48.4)
    0 (0.0 to 33.6)
    22.2 (2.8 to 60.0)
        Fatigue: Moderate
    8.3 (0.2 to 38.5)
    25.0 (5.5 to 57.2)
    25.0 (5.5 to 57.2)
    50.0 (21.1 to 78.9)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    16.7 (2.1 to 48.4)
    11.1 (0.3 to 48.2)
    0 (0.0 to 26.5)
    16.7 (2.1 to 48.4)
    25.0 (5.5 to 57.2)
    11.1 (0.3 to 48.2)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    22.2 (2.8 to 60.0)
    11.1 (0.3 to 48.2)
        Fatigue: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.3 to 48.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Fatigue: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Headache: Mild
    33.3 (9.9 to 65.1)
    41.7 (15.2 to 72.3)
    16.7 (2.1 to 48.4)
    41.7 (15.2 to 72.3)
    66.7 (9.4 to 99.2)
    33.3 (9.9 to 65.1)
    25.0 (5.5 to 57.2)
    25.0 (5.5 to 57.2)
    11.1 (0.3 to 48.2)
    16.7 (2.1 to 48.4)
    16.7 (2.1 to 48.4)
    41.7 (15.2 to 72.3)
    0 (0.0 to 33.6)
    8.3 (0.2 to 38.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    22.2 (2.8 to 60.0)
        Headache: Moderate
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    33.3 (9.9 to 65.1)
    25.0 (5.5 to 57.2)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    8.3 (0.2 to 38.5)
    16.7 (2.1 to 48.4)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    11.1 (0.3 to 48.2)
    11.1 (0.3 to 48.2)
        Headache: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.)
        Headache: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Chills: Mild
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    25.0 (5.5 to 57.2)
    41.7 (15.2 to 72.3)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 33.6)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    22.2 (2.8 to 60.0)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Chills: Moderate
    8.3 (0.2 to 38.5)
    16.7 (2.1 to 48.4)
    33.3 (9.9 to 65.1)
    33.3 (9.9 to 65.1)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Chills: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Chills: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Vomiting: Mild
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Vomiting: Moderate
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Vomiting: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.6)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Vomiting: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Diarrhea: Mild
    16.7 (2.1 to 48.4)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    33.3 (9.9 to 65.1)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    11.1 (0.3 to 48.2)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    11.1 (0.3 to 48.2)
    0 (0.0 to 33.6)
        Diarrhea: Moderate
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Diarrhea: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Diarrhea: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        New or worsened muscle pain: Mild
    8.3 (0.2 to 38.5)
    25.0 (5.5 to 57.2)
    16.7 (2.1 to 48.4)
    41.7 (15.2 to 72.3)
    0 (0.0 to 70.8)
    25.0 (5.5 to 57.2)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    16.7 (2.1 to 48.4)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        New or worsened muscle pain: Moderate
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    16.7 (2.1 to 48.4)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    11.1 (0.3 to 48.2)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    11.1 (0.3 to 48.2)
    0 (0.0 to 33.6)
        New or worsened muscle pain: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    11.1 (0.3 to 48.2)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    11.1 (0.3 to 48.2)
    0 (0.0 to 33.6)
        New or worsened muscle pain: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 48.2)
    0 (0.0 to 33.6)
        New or worsened joint pain: Mild
    16.7 (2.1 to 48.4)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 70.8)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    11.1 (0.3 to 48.2)
    16.7 (2.1 to 48.4)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        New or worsened joint pain: Moderate
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    11.1 (0.3 to 48.2)
    0 (0.0 to 33.6)
        New or worsened joint pain: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        New or worsened joint pain: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Systemic Events Within 7 Days After Dose 2: Phase 1

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    End point title
    		 Percentage of Subjects With Systemic Events Within 7 Days After Dose 2: Phase 1 [4]
    End point description
    Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by subjects using e-diary. Fever=temperature >=38.0 degrees C categorised as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0-degrees C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalisation). Vomiting: mild (1-2 times in 24 hours[h]), moderate (more than 2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalisation for hypotensive shock). Diarrhea:mild (2 to 3 loose stools in 24h), moderate (4 to 5 loose stools in 24 h), severe (6 or more loose stools in 24 h) and Grade 4 (emergency room visit/hospitalisation). Safety population assessed.
    End point type
    Primary
    End point timeframe
    Within 7 Days After Dose 2
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis performed for this endpoint
    End point values
    		 BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
    number (confidence interval 95%)
        Fever: 38.0°C to 38.4°C
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    16.7 (2.1 to 48.4)
    33.3 (9.9 to 65.1)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    25.0 (5.5 to 57.2)
    16.7 (2.1 to 48.4)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Fever: >38.4°C to 38.9°C
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    58.3 (27.7 to 84.8)
    16.7 (2.1 to 48.4)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    25.0 (5.5 to 57.2)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Fever: >38.9°C to 40.0°C
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Fever: >40.0°C
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Fatigue: Mild
    25.0 (5.5 to 57.2)
    50.0 (21.1 to 78.9)
    16.7 (2.1 to 48.4)
    16.7 (2.1 to 48.4)
    33.3 (0.8 to 90.6)
    25.0 (5.5 to 57.2)
    33.3 (9.9 to 65.1)
    16.7 (2.1 to 48.4)
    11.1 (0.3 to 48.2)
    16.7 (2.1 to 48.4)
    8.3 (0.2 to 38.5)
    25.0 (5.5 to 57.2)
    11.1 (0.3 to 48.2)
    8.3 (0.2 to 38.5)
    33.3 (9.9 to 65.1)
    16.7 (2.1 to 48.4)
    0 (0.0 to 33.6)
    22.2 (0.0 to 33.6)
        Fatigue: Moderate
    33.3 (9.9 to 65.1)
    25.0 (5.5 to 57.2)
    66.7 (34.9 to 90.1)
    50.0 (21.1 to 78.9)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    16.7 (2.1 to 48.4)
    11.1 (0.3 to 48.2)
    8.3 (0.2 to 38.5)
    41.7 (15.2 to 72.3)
    33.3 (9.9 to 65.1)
    11.1 (0.3 to 48.2)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    11.1 (0.3 to 48.2)
    11.1 (0.3 to 48.2)
        Fatigue: Severe
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Fatigue: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Headache: Mild
    58.3 (27.7 to 84.8)
    50.0 (21.1 to 78.9)
    58.3 (27.7 to 84.8)
    41.7 (15.2 to 72.3)
    66.7 (9.4 to 99.2)
    33.3 (9.9 to 65.1)
    25.0 (5.5 to 57.2)
    25.0 (5.5 to 57.2)
    0 (0.0 to 33.6)
    33.3 (9.9 to 65.1)
    33.3 (9.9 to 65.1)
    50.0 (2.1 to 78.9)
    11.1 (0.3 to 48.2)
    25.0 (5.5 to 57.2)
    25.0 (5.5 to 57.2)
    16.7 (2.1 to 48.4)
    0 (0.0 to 33.6)
    22.2 (2.8 to 60.0)
        Headache: Moderate
    25.0 (5.5 to 57.2)
    16.7 (2.1 to 48.4)
    41.7 (15.2 to 72.3)
    25.0 (5.5 to 57.2)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    8.3 (0.2 to 38.5)
    33.3 (9.9 to 65.1)
    25.0 (5.5 to 57.2)
    0 (0.0 to 33.6)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    11.1 (0.3 to 48.2)
    11.1 (0.3 to 48.2)
        Headache: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Headache: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Chills: Mild
    0 (0.0 to 26.5)
    16.7 (2.1 to 48.4)
    41.7 (15.2 to 72.3)
    41.7 (15.2 to 72.3)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 33.6)
    16.7 (2.1 to 48.4)
    33.3 (9.9 to 65.1)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    16.7 (2.1 to 48.4)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Chills: Moderate
    25.0 (5.5 to 57.2)
    33.3 (9.9 to 65.1)
    16.7 (2.1 to 48.4)
    33.3 (9.9 to 65.1)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    8.3 (0.2 to 38.5)
    25.0 (5.5 to 57.2)
    25.0 (5.5 to 57.2)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Chills: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Chills: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Vomiting: Mild
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Vomiting: Moderate
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Vomiting: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Vomiting: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Diarrhea: Mild
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    33.3 (9.9 to 65.1)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    11.1 (0.3 to 48.2)
    0 (0.0 to 33.6)
        Diarrhea: Moderate
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Diarrhea: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        Diarrhea: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        New or worsened muscle pain: Mild
    33.3 (9.9 to 65.1)
    16.7 (2.1 to 48.4)
    16.7 (2.1 to 48.4)
    41.7 (15.2 to 72.3)
    0 (0.0 to 70.8)
    25.0 (5.5 to 57.2)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    16.7 (2.1 to 48.4)
    8.3 (0.2 to 38.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 33.6)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    16.7 (2.1 to 48.4)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        New or worsened muscle pain: Moderate
    8.3 (0.2 to 38.5)
    58.3 (27.7 to 84.8)
    41.7 (15.2 to 72.3)
    8.3 (0.2 to 38.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    16.7 (2.1 to 48.4)
    25.0 (5.5 to 57.2)
    16.7 (2.1 to 48.4)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    11.1 (0.3 to 48.2)
    0 (0.0 to 33.6)
        New or worsened muscle pain: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        New or worsened muscle pain: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        New or worsened joint pain: Mild
    8.3 (0.2 to 38.5)
    33.3 (9.9 to 65.1)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 70.8)
    8.3 (0.2 to 38.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    16.7 (2.1 to 48.4)
    16.7 (2.1 to 48.4)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        New or worsened joint pain: Moderate
    25.0 (5.5 to 57.2)
    16.7 (2.1 to 48.4)
    16.7 (2.1 to 48.4)
    8.3 (0.2 to 38.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    11.1 (0.3 to 48.2)
    0 (0.0 to 33.6)
        New or worsened joint pain: Severe
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
        New or worsened joint pain: Grade 4
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 70.8)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0 (0.0 to 33.6)
    0 (0.0 to 33.6)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: Phase 1

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    End point title
    		 Percentage of Subjects Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: Phase 1 [5]
    End point description
    An AE was any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. For BNT162b1 100 mcg, subjects received one dose of 100 mcg, followed by one dose of 10 mcg. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    From Dose 1 to 1 Month After Dose 2
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis performed for this endpoint
    End point values
    		 BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age BNT162b1 10 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    9
    12
    12
    12
    9
    9
    9
    Units: Percentage of subjects
        number (not applicable)
    50.0
    41.7
    50.0
    66.7
    33.3
    33.3
    41.7
    41.7
    22.2
    58.3
    25.0
    44.4
    8.3
    8.3
    25.0
    50.0
    22.2
    22.2
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: Phase 1

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    End point title
    		 Percentage of Subjects Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: Phase 1 [6]
    End point description
    An SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalisation or prolongation of existing hospitalisation; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method. For BNT162b1 100 mcg, subjects received one dose of 100 mcg, followed by one dose of 10 mcg. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    From Dose 1 to 6 Months After Dose 2
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis performed for this endpoint
    End point values
    		 BNT162b1 10 mcg dose, 18-85 years of age BNT162b1 20 mcg dose, 18-85 years of age BNT162b1 30 mcg dose, 18-85 years of age BNT162b2 10 mcg dose, 18-85 years of age BNT162b2 20 mcg dose, 18-85 years of age BNT162b2 30 mcg dose, 18-85 years of age BNT162b1 100 mcg: 18-85 years of age Placebo/BNT162b2 30 mcg: 18-85 years of age
    Number of subjects analysed
    24
    24
    24
    24
    24
    24
    12
    35
    Units: Percentage of subjects
        number (confidence interval 95%)
    0 (0.0 to 14.2)
    0 (0.0 to 14.2)
    0 (0.0 to 14.2)
    0 (0.0 to 14.2)
    4.2 (0.1 to 21.1)
    4.2 (0.1 to 21.1)
    0 (0.0 to 26.5)
    0 (0.0 to 10.0)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Abnormalities in Hematology Parameters 1 Day After Dose 1: Phase 1

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    End point title
    		 Percentage of Subjects With Abnormalities in Hematology Parameters 1 Day After Dose 1: Phase 1 [7]
    End point description
    Hematology parameters that were assessed included hemoglobin, hematocrit, erythrocytes, Ery. mean corpuscular volume, Ery. mean corpuscular hemoglobin, Ery. mean corpuscular HGB concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils and monocytes. Only parameters with abnormal values were reported. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    1 Day after Dose 1
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis performed for this endpoint
    End point values
    		 BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
    number (not applicable)
        Lymphocytes
    8.3
    33.3
    54.5
    75.0
    75.0
    0
    8.3
    8.3
    0
    8.3
    25.0
    16.7
    0
    8.3
    8.3
    8.3
    0
    0
        Neutrophils
    8.3
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    16.7
    0
    0
    0
        Ery. Mean Corpuscular Hemoglobin
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Abnormalities in Hematology Parameters 7 Days After Dose 1: Phase 1

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    End point title
    		 Percentage of Subjects With Abnormalities in Hematology Parameters 7 Days After Dose 1: Phase 1 [8]
    End point description
    Hematology parameters that were assessed included hemoglobin, hematocrit, erythrocytes, Ery. mean corpuscular volume, Ery. mean corpuscular hemoglobin, Ery. mean corpuscular HGB concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils and monocytes. Only parameters with abnormal values were reported. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    Within 7 Days after Dose 1
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis performed for this endpoint
    End point values
    		 BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
    number (not applicable)
        Lymphocytes
    0
    0
    0
    0
    11.1
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    8.3
    11.1
    0
        Neutrophils
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    16.7
    0
    0
    8.3
    0
    0
    0
    0
        Ery. Mean Corpuscular Hemoglobin
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Abnormalities in Hematology Parameters Before Dose 2: Phase 1

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    End point title
    		 Percentage of Subjects With Abnormalities in Hematology Parameters Before Dose 2: Phase 1 [9]
    End point description
    Hematology parameters that were assessed included hemoglobin, hematocrit, erythrocytes, Ery. mean corpuscular volume, Ery. mean corpuscular hemoglobin, Ery. mean corpuscular HGB concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils and monocytes. Only parameters with abnormal values were reported. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    Before Dose 2
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis performed for this endpoint
    End point values
    		 BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
    number (not applicable)
        Ery. Mean Corpuscular Hemoglobin
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Neutrophils
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
        Lymphocytes
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    11.1
    8.3
    0
    8.3
    0
    0
        Eosinophils
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Abnormalities in Hematology Parameters 7 Days After Dose 2: Phase 1

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    End point title
    		 Percentage of Subjects With Abnormalities in Hematology Parameters 7 Days After Dose 2: Phase 1 [10]
    End point description
    Hematology parameters that were assessed included hemoglobin, hematocrit, erythrocytes, Ery. mean corpuscular volume, Ery. mean corpuscular hemoglobin, Ery. mean corpuscular HGB concentration, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils and monocytes. Only parameters with abnormal values were reported. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    7 days after Dose 2
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis performed for this endpoint
    End point values
    		 BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    9
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
    number (not applicable)
        Neutrophils
    8.3
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    8.3
    0
    0
    0
    0
        Monocytes
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    11.1
        Eosinophils
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
        Lymphocytes
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    8.3
    0
    0
        Ery. Mean Corpuscular Hemoglobin
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Abnormalities in Chemistry Parameters 1 Day After Dose 1: Phase 1

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    End point title
    		 Percentage of Subjects With Abnormalities in Chemistry Parameters 1 Day After Dose 1: Phase 1 [11]
    End point description
    Chemistry parameters that were assessed included bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), urea nitrogen, creatinine. Abnormal values were reported for bilirubin parameter and were reported in this endpoint. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    1 Day after Dose 1
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis performed for this endpoint
    End point values
    		 BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
        number (not applicable)
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Abnormalities in Chemistry Parameters 7 Days After Dose 1: Phase 1

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    End point title
    		 Percentage of Subjects With Abnormalities in Chemistry Parameters 7 Days After Dose 1: Phase 1 [12]
    End point description
    Chemistry parameters that were assessed included bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), urea nitrogen, creatinine. Abnormal values were reported for bilirubin parameter and were reported in this endpoint. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    7 days after dose 1
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis performed for this endpoint
    End point values
    		 BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
        number (not applicable)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    11.1
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Abnormalities in Chemistry Parameters Before Dose 2: Phase 1

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    End point title
    		 Percentage of Subjects With Abnormalities in Chemistry Parameters Before Dose 2: Phase 1 [13]
    End point description
    Chemistry parameters that were assessed included bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), urea nitrogen, creatinine. Abnormal values were reported for bilirubin parameter and were reported in this endpoint. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    Before Dose 2
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis performed for this endpoint
    End point values
    		 BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
        number (not applicable)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Abnormalities in Chemistry Parameters 7 Days After Dose 2: Phase 1

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    End point title
    		 Percentage of Subjects With Abnormalities in Chemistry Parameters 7 Days After Dose 2: Phase 1 [14]
    End point description
    Chemistry parameters that were assessed included bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), urea nitrogen, creatinine. Abnormal values were reported for bilirubin parameter and were reported in this endpoint. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    7 Days after Dose 2
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis performed for this endpoint
    End point values
    		 BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
        number (not applicable)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    11.1
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Grade Shift in Hematology Parameters 1 Day After Dose 1: Phase 1

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    End point title
    		 Percentage of Subjects With Grade Shift in Hematology Parameters 1 Day After Dose 1: Phase 1 [15]
    End point description
    Hematology parameters that were assessed included hemoglobin, hematocrit, RBC count, MCV, MCH, MCHC, platelet count, WBC count, total neutrophils (Abs), eosinophils (Abs), monocytes (Abs), basophils (Abs), lymphocytes (Abs). Only parameters with non-zero values were reported. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    1 Day After Dose 1
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis performed for this endpoint
    End point values
    		 BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
    number (not applicable)
        Hemoglobin: Baseline Normal to Normal
    75.0
    0
    0
    0
    0
    0
    0
    83.3
    0
    91.7
    0
    0
    0
    0
    0
    0
    0
    0
        Hemoglobin: Normal to Grade 1
    8.3
    0
    0
    0
    0
    0
    0
    16.7
    0
    8.3
    0
    0
    0
    8.3
    0
    0
    0
    0
        Hemoglobin: Grade 1 to Normal
    16.7
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Lymphocytes: Baseline Normal to Normal
    66.7
    25.0
    18.2
    0
    0
    75.0
    75.0
    0
    0
    33.3
    16.7
    41.7
    0
    75.0
    33.3
    66.7
    88.9
    0
        Lymphocytes: Normal to Grade1
    16.7
    41.7
    27.3
    16.7
    0
    25.0
    16.7
    0
    0
    50.0
    16.7
    33.3
    0
    16.7
    50.0
    25.0
    11.1
    0
        Lymphocytes: Normal to Grade2
    8.3
    16.7
    45.5
    50.0
    0
    0
    8.3
    0
    0
    8.3
    66.7
    16.7
    0
    0
    16.7
    0
    0
    0
        Lymphocytes: Normal to Grade3
    8.3
    16.7
    9.1
    33.3
    0
    0
    0
    0
    0
    8.3
    0
    8.3
    0
    8.3
    0
    0
    0
    0
        Neutrophil Decrease: Baseline Normal to Normal
    83.3
    0
    0
    0
    0
    91.7
    91.7
    91.7
    0
    91.7
    91.7
    91.7
    88.9
    83.3
    66.7
    0
    88.9
    87.5
        Neutrophil Decrease: Grade1 to Normal
    8.3
    0
    0
    0
    0
    8.3
    8.3
    8.3
    88.9
    8.3
    8.3
    8.3
    11.1
    16.7
    8.3
    0
    11.1
    12.5
        Platelets Decrease: Normal to Grade1
    0
    91.7
    0
    0
    0
    0
    0
    0
    12.5
    0
    8.3
    8.3
    0
    0
    0
    0
    0
    0
        Urea Nitrogen: Baseline Normal to Normal
    91.7
    8.3
    0
    0
    0
    0
    0
    0
    88.9
    91.7
    0
    0
    88.9
    91.7
    0
    0
    0
    0
        Urea Nitrogen: Grade1 to Normal
    0
    0
    0
    0
    0
    0
    0
    0
    11.1
    8.3
    0
    0
    0
    8.3
    0
    0
    0
    0
        WBC Decrease: Baseline Normal to Normal
    91.7
    91.7
    0
    0
    0
    91.7
    0
    0
    0
    83.3
    75.0
    0
    88.9
    0
    75.0
    91.7
    0
    0
        WBC Decrease: Grade1 to Normal
    8.3
    8.3
    0
    0
    0
    8.3
    0
    0
    0
    16.7
    25.0
    0
    11.1
    83.3
    8.3
    0
    0
    0
        WBC Decrease: Grade1 to Grade2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    16.7
    8.3
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Grade Shift in Hematology Parameters 7 Days After Dose 1: Phase 1

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    End point title
    		 Percentage of Subjects With Grade Shift in Hematology Parameters 7 Days After Dose 1: Phase 1 [16]
    End point description
    Hematology parameters that were assessed included hemoglobin, hematocrit, RBC count, MCV, MCH, MCHC, platelet count, WBC count, total neutrophils (Abs), eosinophils (Abs), monocytes (Abs), basophils (Abs), lymphocytes (Abs). Only parameters with non-zero values were reported. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    7 Days After Dose 1
    Notes
    [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis performed for this endpoint
    End point values
    		 BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
    number (not applicable)
        Hemoglobin: Baseline Normal to Normal
    83.3
    75.0
    0
    91.7
    0
    91.7
    0
    0
    0
    91.7
    83.3
    0
    0
    91.7
    91.7
    91.7
    88.9
    88.9
        Hemoglobin: Grade1 to Normal
    16.7
    8.3
    0
    8.3
    0
    8.3
    0
    0
    0
    8.3
    8.3
    0
    0
    0
    0
    0
    11.1
    11.1
        Hemoglobin: Normal to Grade1
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Hemoglobin: Grade1 to Grade1
    0
    16.7
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    8.3
    8.3
    0
    0
        Hemoglobin: Grade1 to Grade2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
        Lymphocytes: Baseline Normal to Normal
    91.7
    0
    0
    0
    0
    0
    0
    91.7
    0
    0
    0
    0
    0
    0
    91.7
    91.7
    88.9
    77.8
        Lymphocytes: Normal to Grade1
    8.3
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    8.3
    0
    11.1
    11.1
        Lymphocytes: Grade1 to Grade1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
        Neutrophil decrease: Baseline Normal to Normal
    83.3
    91.7
    91.7
    75.0
    0
    83.3
    0
    0
    0
    0
    0
    0
    0
    83.3
    91.7
    0
    88.9
    88.9
        Neutrophil decrease: Normal to Grade1
    8.3
    8.3
    8.3
    25.0
    0
    16.7
    0
    0
    0
    0
    0
    0
    0
    8.3
    8.3
    0
    11.1
    11.1
        Neutrophil decrease: Grade1 to Grade1
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
        Neutrophil decrease: Normal to Grade2
    0
    0
    0
    11.1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Platelets Decrease: Baseline Normal to Normal
    0
    0
    0
    0
    0
    0
    0
    0
    0
    91.7
    91.7
    90.9
    0
    90.9
    0
    0
    77.8
    0
        Platelets Decrease: Normal to Grade1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    8.3
    9.1
    0
    9.1
    0
    0
    11.1
    0
        Platelets Decrease: Grade1 to Grade 2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    11.1
    0
        Urea Nitrogen: Baseline Normal to Normal
    0
    91.7
    91.7
    0
    0
    91.7
    0
    0
    88.9
    91.7
    91.7
    91.7
    88.9
    0
    91.7
    83.3
    88.9
    0
        Urea Nitrogen: Grade1 to Normal
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    8.3
    8.3
    8.3
    8.3
    0
    8.3
    0
    11.1
    0
        Urea Nitrogen: Normal to Grade1
    0
    0
    8.3
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Urea Nitrogen: Grade1 to Grade2
    0
    0
    0
    0
    0
    0
    0
    0
    11.1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Urea Nitrogen: Normal to Grade 2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    11.1
    0
    0
    16.7
    0
    0
        WBC decrease: Baseline Normal to Normal
    0
    91.7
    0
    0
    0
    0
    0
    0
    0
    0
    83.3
    0
    0
    83.3
    0
    91.7
    88.9
    0
        WBC decrease: Normal to Grade1
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    16.7
    0
    0
    8.3
    0
    8.3
    11.1
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Grade Shift in Hematology Parameters Before Dose 2: Phase 1

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    End point title
    		 Percentage of Subjects With Grade Shift in Hematology Parameters Before Dose 2: Phase 1 [17]
    End point description
    Hematology parameters that were assessed included hemoglobin, hematocrit, RBC count, MCV, MCH, MCHC, platelet count, WBC count, total neutrophils (Abs), eosinophils (Abs), monocytes (Abs), basophils (Abs), lymphocytes (Abs). Only parameters with non-zero values were reported. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    Before Dose 2
    Notes
    [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis performed for this endpoint
    End point values
    		 BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
    number (not applicable)
        Hemoglobin: Baseline Normal to Normal
    50.0
    75.0
    0
    0
    0
    0
    0
    83.3
    0
    91.7
    83.3
    0
    0
    91.7
    91.7
    83.3
    0
    88.9
        Hemoglobin: Normal to Grade1
    33.3
    8.3
    0
    0
    0
    0
    0
    16.7
    0
    0
    8.3
    0
    0
    0
    0
    8.3
    0
    11.1
        Hemoglobin: Grade1 to Normal
    16.7
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
        Hemoglobin: Grade1 to Grade1
    0
    16.7
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    8.3
    8.3
    0
    0
    0
        Hemoglobin: Grade1 to Grade2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
        Lymphocytes: Baseline Normal to Normal
    91.7
    83.3
    0
    0
    0
    0
    0
    0
    88.9
    0
    83.3
    0
    0
    91.7
    0
    91.7
    88.9
    0
        Lymphocytes: Normal to Grade1
    8.3
    16.7
    0
    0
    0
    0
    0
    0
    11.1
    0
    16.7
    0
    0
    8.3
    0
    0
    0
    0
        Lymphocytes: Grade1 to Grade1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    11.1
    11.1
        Neutrophil Decrease: Baseline Normal to Normal
    91.7
    0
    0
    0
    0
    83.3
    0
    0
    77.8
    83.3
    83.3
    91.7
    0
    91.7
    83.3
    0
    0
    77.8
        Neutrophil Decrease: Normal to Grade1
    0
    0
    0
    0
    0
    8.3
    0
    0
    22.2
    8.3
    8.3
    0
    0
    8.3
    8.3
    0
    0
    11.1
        Neutrophil Decrease: Normal to Grade2
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Neutrophil Decrease: Grade1 to Grade1
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
        Neutrophil Decrease: Grade1 to Normal
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    8.3
    0
    0
    0
        Platelets Decrease: Baseline Normal to Normal
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    91.7
    0
    91.7
    0
    0
    88.9
    0
        Platelets Decrease: Grade 1 to Grade1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
        Platelets Decrease: Normal to Grade2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
        Platelets Decrease: Grade1 to Grade2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    11.1
    0
        Urea Nitrogen: Baseline Normal to Normal
    0
    91.7
    0
    0
    0
    0
    0
    91.7
    0
    91.7
    0
    0
    77.8
    83.3
    0
    0
    0
    88.9
        Urea Nitrogen: Grade1 to Normal
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Urea Nitrogen: Normal to Grade1
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    8.3
    0
    0
    22.1
    16.7
    0
    0
    0
    0
        Urea Nitrogen: Grade1 to Grade2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    11.1
        WBC Decrease: Baseline Normal to Normal
    0
    91.7
    0
    0
    0
    91.7
    0
    0
    88.9
    91.7
    0
    0
    0
    75.0
    91.7
    0
    0
    77.8
        WBC Decrease: Normal to Grade1
    0
    8.3
    0
    0
    0
    8.3
    0
    0
    11.1
    8.3
    0
    0
    0
    16.7
    8.3
    0
    0
    22.2
        WBC Decrease: Grade1 to Normal
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        WBC Decrease: Grade1 to Grade 1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Grade Shift in Hematology Parameters 7 Days After Dose 2: Phase 1

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    End point title
    		 Percentage of Subjects With Grade Shift in Hematology Parameters 7 Days After Dose 2: Phase 1 [18]
    End point description
    Hematology parameters that were assessed included hemoglobin, hematocrit, RBC count, MCV, MCH, MCHC, platelet count, WBC count, total neutrophils (Abs), eosinophils (Abs), monocytes (Abs), basophils (Abs), lymphocytes (Abs). Only parameters with non-zero values were reported. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    7 Days After Dose 2
    Notes
    [18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis performed for this endpoint
    End point values
    		 BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
    number (not applicable)
        Hemoglobin: Baseline Normal to Normal
    58.3
    66.7
    91.7
    0
    0
    91.7
    0
    66.7
    88.9
    83.3
    83.3
    83.3
    0
    0
    91.7
    91.7
    0
    88.9
        Hemoglobin: Normal to Grade 1
    8.3
    8.3
    8.3
    0
    0
    8.3
    0
    16.7
    11.1
    8.3
    0
    8.3
    0
    0
    0
    0
    0
    11.1
        Hemoglobin: Grade 1 to Normal
    25.0
    0
    0
    0
    0
    0
    0
    16.7
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Hemoglobin: Grade 1 to Grade 1
    8.3
    25.0
    0
    0
    0
    0
    0
    0
    0
    8.3
    8.3
    8.3
    0
    0
    8.3
    0
    0
    0
        Hemoglobin: Grade 2 to Grade 2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
        Lymphocytes: Baseline Normal to Normal
    91.7
    83.3
    0
    0
    0
    0
    0
    0
    88.9
    83.3
    0
    0
    0
    91.7
    0
    91.7
    88.9
    77.8
        Lymphocytes: Normal to Grade 1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    11.1
        Lymphocytes: Grade 1 to Normal
    0
    0
    0
    0
    0
    0
    0
    0
    0
    16.7
    0
    0
    0
    0
    0
    0
    0
    11.1
        Lymphocytes: Grade 1 to Grade 1
    8.3
    16.7
    0
    0
    0
    0
    0
    0
    11.1
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
        Lymphocytes: Grade 1 to Grade 2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    11.1
        Neutrophil Decrease: Baseline Normal to Normal
    75.0
    83.3
    83.3
    0
    0
    83.3
    0
    0
    77.8
    75.0
    83.3
    91.7
    88.9
    58.3
    91.7
    83.3
    88.9
    88.9
        Neutrophil Decrease: Normal to Grade 1
    16.7
    16.7
    8.3
    0
    0
    8
    0
    0
    22.2
    8.3
    0
    8.3
    11.1
    33.3
    0
    8.3
    0
    0
        Neutrophil Decrease: Normal to Grade 2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
        Neutrophil Decrease: Grade 1 to Grade 2
    8.3
    0
    8.3
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    8.3
    0
    0
    0
    0
        Neutrophil Decrease: Grade 1 to Normal
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    8.3
    0
    0
    0
    0
    8.3
    8.3
    0
    11.1
        Neutrophil Decrease: Grade 2 to Grade 1
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Neutrophil Decrease: Grade 1 to Grade 1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    8.3
    0
    0
    0
    0
    0
    11.1
    0
        Platelets Decrease: Baseline Normal to Normal
    0
    0
    91.7
    0
    0
    0
    0
    0
    0
    91.7
    0
    0
    0
    91.7
    0
    0
    88.9
    0
        Platelets Decrease: Normal to Grade 1
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Platelets Decrease: Grade 1 to Grade 1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
        Platelets Decrease: Grade 2 to Grade 1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    11.1
    0
        Urea Nitrogen: Baseline Normal to Normal
    0
    0
    0
    0
    0
    0
    91.7
    91.7
    0
    91.7
    91.7
    0
    77.8
    91.7
    83.3
    75.0
    0
    88.9
        Urea Nitrogen: Normal to Grade 1
    0
    0
    0
    0
    0
    0
    8.3
    8.3
    0
    8.3
    0
    0
    0
    8.3
    16.7
    8.3
    0
    0
        Urea Nitrogen: Grade 1 to Normal
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    11.1
    0
    0
    0
    0
    0
        Urea Nitrogen: Grade 2 to Grade 2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    11.1
        Urea Nitrogen: Grade 1 to Grade 1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    16.7
    0
    0
        Urea Nitrogen: Grade 2 to Normal
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
        Urea Nitrogen: Normal to Grade 2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
        Urea Nitrogen: Grade 1 to Grade 2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    11.1
    0
    0
    0
    0
    0
        WBC Decrease: Baseline Normal to Normal
    91.7
    0
    91.7
    0
    0
    91.7
    0
    0
    88.9
    0
    83.3
    0
    0
    0
    0
    0
    0
    77.8
        WBC Decrease: Normal to Grade 1
    8.3
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    8.3
    8.3
    0
    75.0
    0
    91.7
    0
    0
        WBC Decrease: Grade 1 to Normal
    83.3
    8.3
    0
    0
    0
    0
    0
    0
    11.1
    0
    8.3
    0
    0
    8.3
    0
    0
    0
    22.2
        WBC Decrease: Grade 1 to Grade 1
    8.3
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    16.7
    0
    8.3
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Grade Shift in Chemistry Parameters 1 Day After Dose 1: Phase 1

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    End point title
    		 Percentage of Subjects With Grade Shift in Chemistry Parameters 1 Day After Dose 1: Phase 1 [19]
    End point description
    Chemistry parameters that were assessed included bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, urea nitrogen, creatinine. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    1 Day After Dose 1
    Notes
    [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis performed for this endpoint
    End point values
    		 BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
    number (not applicable)
        ALT Increased: Baseline Normal to Normal
    0
    0
    0
    0
    0
    0
    91.7
    91.7
    0
    0
    0
    0
    88.9
    0
    0
    0
    0
    0
        ALT Increased: Normal to Grade 1
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    11.1
    0
    0
    0
    0
    0
        ALT Increased: Grade 1 to Grade 1
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        ALP Increased: Baseline Normal to Normal
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    91.7
    88.9
    0
    0
    0
    0
    0
        ALP Increased: Grade 1 to Grade 1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
        ALP Increased: Grade 1 to Normal
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    11.1
    0
    0
    0
    0
    0
        AST Increased: Baseline Normal to Normal
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    91.7
    0
    0
        AST Increased: Normal to Grade 1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
        Bilirubin: Baseline Normal to Normal
    0
    0
    0
    91.7
    0
    91.7
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    88.9
        Bilirubin: Grade 2 to Grade 3
    0
    0
    0
    8.3
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Bilirubin: Grade 1 to Grade 1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    11.1
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Grade Shift in Chemistry Parameters 7 Days After Dose 1: Phase 1

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    End point title
    		 Percentage of Subjects With Grade Shift in Chemistry Parameters 7 Days After Dose 1: Phase 1 [20]
    End point description
    Chemistry parameters that were assessed included bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, urea nitrogen, creatinine. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    7 Days After Dose 1
    Notes
    [20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis performed for this endpoint
    End point values
    		 BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
    number (not applicable)
        ALT Increased: Baseline Normal to Normal
    0
    0
    0
    0
    0
    0
    91.7
    91.7
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        ALT Increased: Normal to Grade 1
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        ALT Increased: Grade 1 to Grade 1
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        ALP Increased: Baseline Normal to Normal
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    91.7
    88.9
    0
    0
    0
    0
    0
        ALP Increased: Grade 1 to Grade 1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    11.1
    0
    0
    0
    0
    0
        Bilirubin: Baseline Normal to Normal
    0
    0
    91.7
    0
    0
    91.7
    0
    0
    0
    0
    0
    0
    0
    0
    0
    91.7
    0
    0
        Bilirubin: Normal to Grade 1
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
        Bilirubin: Grade 2 to Grade 1
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Bilirubin: Grade 1 to Grade 2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    11.1
        Creatinine Increased: Baseline Normal to Normal
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    88.9
        Creatinine Increased: Normal to Grade 1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    11.1
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Grade Shift in Chemistry Parameters Before Dose 2: Phase 1

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    End point title
    		 Percentage of Subjects With Grade Shift in Chemistry Parameters Before Dose 2: Phase 1 [21]
    End point description
    Chemistry parameters that were assessed included bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, urea nitrogen, creatinine. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    Before Dose 2
    Notes
    [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis performed for this endpoint
    End point values
    		 BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
    number (not applicable)
        ALT Increased: Baseline Normal to Normal
    0
    91.7
    0
    0
    0
    0
    91.7
    91.7
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        ALT Increased: Normal to Grade 1
    0
    8.3
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        ALT Increased: Grade 1 to Normal
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        ALP Increased: Baseline Normal to Normal
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    91.7
    88.9
    0
    0
    0
    0
    0
        ALP Increased: Grade 1 to Grade 1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    11.1
    0
    0
    0
    0
    0
        AST Increased: Baseline Normal to Normal
    0
    90.9
    90.9
    0
    0
    0
    0
    0
    0
    0
    0
    0
    85.7
    0
    0
    0
    0
    0
        AST Increased: Normal to Grade 1
    0
    9.1
    9.1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    14.3
    0
    0
    0
    0
    0
        Bilirubin: Baseline Normal to Normal
    0
    0
    91.7
    0
    0
    91.7
    0
    91.7
    0
    0
    0
    0
    0
    0
    0
    0
    0
    88.9
        Bilirubin: Normal to Grade 1
    0
    0
    8.3
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Bilirubin: Grade 2 to Grade 1
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Bilirubin: Grade 1 to Grade 1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    11.1
        Creatinine Increased: Baseline Normal to Normal
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    88.9
        Creatinine Increased: Normal to Grade 1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    11.1
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Grade Shift in Chemistry Parameters 7 Days After Dose 2: Phase 1

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    End point title
    		 Percentage of Subjects With Grade Shift in Chemistry Parameters 7 Days After Dose 2: Phase 1 [22]
    End point description
    Chemistry parameters that were assessed included bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, urea nitrogen, creatinine. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    7 Days After Dose 2
    Notes
    [22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis performed for this endpoint
    End point values
    		 BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Percentage of subjects
    number (not applicable)
        ALT Increased: Baseline Normal to Normal
    0
    91.7
    91.7
    0
    0
    0
    91.7
    83.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        ALT Increased: Grade 1 to Normal
    0
    8.3
    0
    0
    0
    0
    0
    16.7
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        ALT Increased: Normal to Grade 1
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        ALT Increased: Grade 1 to Grade 1
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        ALP Increased: Baseline Normal to Normal
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    91.7
    91.7
    88.9
    0
    0
    0
    0
    0
        ALP Increased: Normal to Grade 1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
        ALP Increased: Grade 1 to Grade 1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    8.3
    11.1
    0
    0
    0
    0
    0
        AST Increased: Baseline Normal to Normal
    0
    90.9
    91.7
    0
    0
    0
    0
    90.9
    0
    0
    0
    0
    85.7
    0
    0
    91.7
    0
    0
        AST Increased: Grade 1 to Normal
    0
    9.1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    14.3
    0
    0
    0
    0
    0
        AST Increased: Grade 1 to Grade 1
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        AST Increased: Normal to Grade 1
    0
    0
    0
    0
    0
    0
    0
    9.1
    0
    0
    0
    0
    0
    0
    0
    8.3
    0
    0
        Bilirubin: Baseline Normal to Normal
    0
    0
    91.7
    0
    0
    91.7
    0
    91.7
    0
    0
    0
    0
    0
    0
    0
    0
    0
    88.9
        Bilirubin: Grade 1 to Normal
    0
    0
    8.3
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Bilirubin: Grade 1 to Grade 1
    0
    0
    0
    0
    0
    8.3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Bilirubin: Grade 1 to Grade 2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    11.1
        Creatinine Increased: Baseline Normal to Normal
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    88.9
        Creatinine Increased: Grade 1 to Normal
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    11.1
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Local Reactions Within 7 Days After Dose 1: Phase 2/3

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    End point title
    		 Percentage of Subjects With Local Reactions Within 7 Days After Dose 1: Phase 2/3 [23]
    End point description
    Local reactions included redness, swelling and, pain at the injection site, recorded by subjects or parents/legal guardians of subjects in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild > 2.0 to 5.0 cm, moderate (> 5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalisation for severe pain). 95 % CI was based on Clopper and Pearson method. Safety population include all randomised subjects who received at least 1 dose of the study intervention.Number of Subjects Analysed signifies the subjects in the safety population and had e-diary data after Dose 1. HIV positive subjects were excluded from this analysis.
    End point type
    Primary
    End point timeframe
    Within 7 Days after Dose 1
    Notes
    [23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis performed for this endpoint
    End point values
    		 BNT162b2 (30 mcg): 16-55 Years BNT162b2 (30 mcg): 56-85 Years Placebo:16-55 Years Placebo: 56 to 85 Years BNT162b2 (30 mcg): 12-15 years of age Placebo: 12-15 years of age
    Number of subjects analysed
    2899
    2008
    2908
    1989
    1127
    1127
    Units: Percentage of subjects
    number (confidence interval 95%)
        Redness: Mild
    3.9 (3.2 to 4.7)
    3.5 (2.8 to 4.4)
    0.7 (0.4 to 1.0)
    0.7 (0.3 to 1.1)
    3.9 (2.9 to 5.2)
    1.0 (0.5 to 1.7)
        Redness: Moderate
    1.2 (0.9 to 1.7)
    1.5 (1.0 to 2.1)
    0.2 (0.1 to 0.4)
    0.3 (0.1 to 0.6)
    1.8 (1.1 to 2.7)
    0.1 (0.0 to 0.5)
        Redness: Severe
    0.2 (0.1 to 0.5)
    0.2 (0.1 to 0.6)
    0.1 (0.0 to 0.3)
    0.1 (0.0 to 0.4)
    0.1 (0.0 to 0.5)
    0.0 (0.0 to 0.3)
        Redness: Grade 4
    0 (0.0 to 0.1)
    0.0 (0.0 to 0.2)
    0 (0.0 to 0.1)
    0.0 (0.0 to 0.2)
    0.0 (0.0 to 0.3)
    0.0 (0.0 to 0.3)
        Swelling: Mild
    4.3 (3.6 to 5.1)
    4.3 (3.5 to 5.3)
    0.2 (0.1 to 0.4)
    0.6 (0.3 to 1.0)
    4.9 (3.7 to 6.3)
    0.8 (0.4 to 1.5)
        Swelling: Moderate
    1.9 (1.4 to 2.4)
    2.6 (1.9 to 3.4)
    0.3 (0.1 to 0.5)
    0.6 (0.3 to 1.1)
    2.0 (1.3 to 3.0)
    0.2 (0.0 to 0.6)
        Swelling: Severe
    0.2 (0.1 to 0.4)
    0.1 (0.0 to 0.4)
    0.1 (0.0 to 0.2)
    0.0 (0.0 to 0.2)
    0.0 (0.0 to 0.3)
    0.0 (0.0 to 0.3)
        Swelling: Grade 4
    0 (0.0 to 0.1)
    0.0 (0.0 to 0.2)
    0 (0.0 to 0.1)
    0.0 (0.0 to 0.2)
    0.0 (0.0 to 0.3)
    0.0 (0.0 to 0.3)
        Pain at injection site: Mild
    50.5 (48.7 to 52.3)
    55.2 (53.0 to 57.4)
    13.4 (12.2 to 14.7)
    8.9 (7.7 to 10.2)
    41.4 (38.5 to 44.4)
    20.1 (17.8 to 22.6)
        Pain at injection site: Moderate
    31.8 (30.1 to 33.6)
    14.7 (13.2 to 16.4)
    0.7 (0.4 to 1.1)
    0.4 (0.2 to 0.8)
    43.7 (40.8 to 46.7)
    3.2 (2.2 to 4.4)
        Pain at injection site: Severe
    1.3 (1.0 to 1.8)
    0.2 (0.1 to 0.5)
    0.1 (0.0 to 0.3)
    0.0 (0.0 to 0.2)
    1.0 (0.5 to 1.7)
    0.0 (0.0 to 0.3)
        Pain at injection site: Grade 4
    0.0 (0.0 to 0.1)
    0.0 (0.0 to 0.2)
    0.0 (0.0 to 0.1)
    0.0 (0.0 to 0.2)
    0.0 (0.0 to 0.3)
    0.0 (0.0 to 0.3)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Local Reactions Within 7 Days After Dose 2: Phase 2/3

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    End point title
    		 Percentage of Subjects With Local Reactions Within 7 Days After Dose 2: Phase 2/3 [24]
    End point description
    Local reactions included redness, swelling and, pain at the injection site, recorded by subjects or parent/legal guardian of subjects in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild > 2.0 to 5.0 cm, moderate (> 5.0 to 10.0 cm), severe (>10.0 cm) and Grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (does not interfere with activity), moderate (interferes with activity), severe (prevents daily activity) and Grade 4 (emergency room visit or hospitalisation for severe pain). 95 % CI was based on Clopper and Pearson method. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    Within 7 Days after Dose 2
    Notes
    [24] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis performed for this endpoint
    End point values
    		 BNT162b2 (30 mcg): 16-55 Years BNT162b2 (30 mcg): 56-85 Years Placebo:16-55 Years Placebo: 56 to 85 Years BNT162b2 (30 mcg): 12-15 years of age Placebo: 12-15 years of age
    Number of subjects analysed
    2682
    1860
    2684
    1833
    1097
    1078
    Units: Percentage of subjects
    number (confidence interval 95%)
        Redness: Mild
    3.4 (2.7 to 4.1)
    3.5 (2.7 to 4.4)
    0.4 (0.2 to 0.8)
    0.5 (0.3 to 1.0)
    2.6 (1.8 to 3.8)
    0.7 (0.3 to 1.5)
        Redness: Moderate
    1.9 (1.4 to 2.5)
    3.1 (2.4 to 4.0)
    0.2 (0.1 to 0.5)
    0.2 (0.0 to 0.5)
    2.4 (1.6 to 3.5)
    0.2 (0.0 to 0.7)
        Redness: Severe
    0.4 (0.2 to 0.7)
    0.5 (0.3 to 1.0)
    0 (0.0 to 0.1)
    0.1 (0.0 to 0.3)
    0 (0.0 to 0.3)
    0 (0.0 to 0.3)
        Redness: Grade 4
    0 (0.0 to 0.1)
    0 (0.0 to 0.2)
    0 (0.0 to 0.1)
    0 (0.0 to 0.2)
    0 (0.0 to 0.3)
    0 (0.0 to 0.3)
        Swelling: Mild
    4.1 (3.4 to 4.9)
    4.3 (3.4 to 5.3)
    0.1 (0.0 to 0.3)
    0.3 (0.1 to 0.6)
    3.3 (2.3 to 4.5)
    0.4 (0.1 to 0.9)
        Swelling: Moderate
    2.5 (1.9 to 3.1)
    3.3 (2.5 to 4.2)
    0.1 (0.0 to 0.3)
    0.4 (0.2 to 0.8)
    1.6 (1.0 to 2.6)
    0.2 (0.0 to 0.7)
        Swelling: Severe
    0.3 (0.1 to 0.5)
    0.2 (0.1 to 0.5)
    0 (0.0 to 0.1)
    0.1 (0.0 to 0.3)
    0 (0.0 to 0.3)
    0 (0.0 to 0.3)
        Swelling: Grade 4
    0 (0.0 to 0.1)
    0 (0.0 to 0.2)
    0 (0.0 to 0.1)
    0 (0.0 to 0.2)
    0 (0.0 to 0.3)
    0 (0.0 to 0.3)
        Pain at injection site: Mild
    47.5 (45.6 to 49.4)
    46.9 (44.6 to 49.2)
    10.6 (9.4 to 11.8)
    7.5 (6.4 to 8.8)
    42.5 (39.5 to 45.5)
    15.2 (13.1 to 17.5)
        Pain at injection site: Moderate
    29.4 (27.7 to 31.1)
    18.7 (16.9 to 20.5)
    1.0 (0.7 to 1.5)
    0.3 (0.1 to 0.6)
    35.8 (33.0 to 38.7)
    2.7 (1.8 to 3.8)
        Pain at injection site: Severe
    1.5 (1.0 to 2.0)
    0.5 (0.3 to 1.0)
    0 (0.0 to 0.1)
    0 (0.0 to 0.2)
    0.6 (0.3 to 1.3)
    0 (0.0 to 0.3)
        Pain at injection site: Grade 4
    0 (0.0 to 0.1)
    0 (0.0 to 0.2)
    0 (0.0 to 0.1)
    0 (0.0 to 0.2)
    0 (0.0 to 0.3)
    0 (0.0 to 0.3)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Systemic Events Within 7 Days After Dose 1: Phase 2/3

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    End point title
    		 Percentage of Subjects With Systemic Events Within 7 Days After Dose 1: Phase 2/3 [25]
    End point description
    Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by subjects or parents/legal guardians of subjects. Fever=temperature >=38.0 degrees C categorised as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0-degrees C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalisation). Vomiting: mild (1-2 times in 24 hours[h]), moderate (more than 2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalisation for hypotensive shock). Diarrhea:mild (2 to 3 loose stools in 24h), moderate (4 to 5 loose stools in 24 h), severe (6 or more loose stools in 24 h) and Grade 4 (emergency room visit/hospitalisation). Safety population assessed.
    End point type
    Primary
    End point timeframe
    Within 7 Days after Dose 1
    Notes
    [25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis performed for this endpoint
    End point values
    		 BNT162b2 (30 mcg): 56-85 Years BNT162b2 (30 mcg): 18-55 Years Placebo: 18-85 Years Placebo: 56-85 Years BNT162b2 (30 mcg): 12-15 years of age Placebo: 12-15 years of age
    Number of subjects analysed
    2008
    2899
    2908
    1989
    1127
    1127
    Units: Percentage of subjects
    number (confidence interval 95%)
        Fever: 38.0°C to 38.4°C
    1.1 (0.7 to 1.7)
    3.0 (2.4 to 3.7)
    0.6 (0.3 to 0.9)
    0.4 (0.2 to 0.8)
    6.6 (5.2 to 8.2)
    0.7 (0.3 to 1.4)
        Fever: >38.4°C to 38.9°C
    0.1 (0.0 to 0.4)
    0.9 (0.6 to 1.3)
    0.2 (0.1 to 0.4)
    0.2 (0.0 to 0.4)
    2.6 (1.7 to 3.7)
    0.2 (0.0 to 0.6)
        Fever: >38.9°C to 40.0°C
    0.0 (0.0 to 0.3)
    0.3 (0.1 to 0.5)
    0.1 (0.0 to 0.4)
    0.2 (0.0 to 0.4)
    0.9 (0.4 to 1.6)
    0.2 (0.0 to 0.6)
        Fever: >40.0°C
    0 (0.0 to 0.2)
    0 (0.0 to 0.1)
    0 (0.0 to 0.1)
    0 (0.0 to 0.2)
    0.1 (0.0 to 0.5)
    0 (0.0 to 0.3)
        Fatigue: Mild
    20.7 (18.9 to 22.5)
    26.2 (24.6 to 27.9)
    19.6 (18.2 to 21.1)
    14.1 (12.6 to 15.7)
    24.7 (22.2 to 27.3)
    22.2 (19.8 to 24.7)
        Fatigue: Moderate
    12.9 (11.5 to 14.4)
    21.7 (20.2 to 23.3)
    12.8 (11.6 to 14.1)
    8.2 (7.0 to 9.5)
    34.1 (31.3 to 36.9)
    17.7 (15.5 to 20.0)
        Fatigue: Severe
    0.1 (0.0 to 0.4)
    1.4 (1.0 to 1.9)
    0.6 (0.4 to 1.0)
    0.2 (0.0 to 0.4)
    1.3 (0.7 to 2.2)
    0.7 (0.3 to 1.4)
        Fatigue: Grade 4
    0 (0.0 to 0.2)
    0 (0.0 to 0.1)
    0 (0.0 to 0.1)
    0 (0.0 to 0.2)
    0 (0.0 to 0.3)
    0 (0.0 to 0.3)
        Headache: Mild
    19.0 (17.3 to 20.8)
    27.1 (25.5 to 28.7)
    21.8 (20.3 to 23.3)
    13.4 (12.0 to 15.0)
    32.0 (29.3 to 34.8)
    22.7 (20.3 to 25.3)
        Headache: Moderate
    6.0 (5.0 to 7.1)
    15.3 (14.0 to 16.7)
    10.9 (9.8 to 12.1)
    4.7 (3.8 to 5.7)
    22.3 (19.9 to 24.8)
    11.6 (9.8 to 13.6)
        Headache: Severe
    0.1 (0.0 to 0.4)
    1.1 (0.8 to 1.6)
    0.8 (0.5 to 1.2)
    0.2 (0.0 to 0.4)
    1.0 (0.5 to 1.7)
    0.8 (0.4 to 1.5)
        Headache: Grade 4
    0 (0.0 to 0.2)
    0 (0.0 to 0.1)
    0 (0.0 to 0.1)
    0 (0.0 to 0.2)
    0 (0.0 to 0.3)
    0 (0.0 to 0.3)
        Chills: Mild
    5.1 (4.2 to 6.1)
    11.7 (10.5 to 12.9)
    5.1 (4.3 to 6.0)
    2.5 (1.8 to 3.2)
    17.3 (15.1 to 19.6)
    7.3 (5.8 to 9.0)
        Chills: Moderate
    1.4 (0.9 to 2.0)
    4.3 (3.6 to 5.2)
    1.7 (1.2 to 2.2)
    1.0 (0.6 to 1.5)
    9.8 (8.2 to 11.7)
    2.2 (1.4 to 3.3)
        Chills: Severe
    0 (0.0 to 0.2)
    0.5 (0.3 to 0.9)
    0.1 (0.0 to 0.2)
    0 (0.0 to 0.2)
    0.4 (0.1 to 1.0)
    0.2 (0.0 to 0.6)
        Chills: Grade 4
    0 (0.0 to 0.2)
    0 (0.0 to 0.1)
    0 (0.0 to 0.1)
    0 (0.0 to 0.2)
    0 (0.0 to 0.3)
    0 (0.0 to 0.3)
        Vomiting: Mild
    0.4 (0.2 to 0.8)
    1.0 (0.7 to 1.4)
    1.0 (0.7 to 1.5)
    0.5 (0.2 to 0.9)
    2.7 (1.8 to 3.8)
    0.7 (0.3 to 1.4)
        Vomiting: Moderate
    0.0 (0.0 to 0.3)
    0.2 (0.1 to 0.4)
    0.2 (0.1 to 0.4)
    0 (0.0 to 0.2)
    0 (0.0 to 0.3)
    0.2 (0.0 to 0.6)
        Vomiting: Severe
    0 (0.0 to 0.2)
    0 (0.0 to 0.1)
    0 (0.0 to 0.2)
    0 (0.0 to 0.2)
    0.1 (0.0 to 0.5)
    0 (0.0 to 0.3)
        Vomiting: Grade 4
    0 (0.0 to 0.2)
    0 (0.0 to 0.1)
    0 (0.0 to 0.1)
    0 (0.0 to 0.2)
    0 (0.0 to 0.3)
    0 (0.0 to 0.3)
        Diarrhea: Mild
    6.8 (5.8 to 8.0)
    8.7 (7.7 to 9.7)
    9.1 (8.1 to 10.2)
    5.5 (4.5 to 6.6)
    6.8 (5.4 to 8.5)
    6.4 (5.0 to 8.0)
        Diarrhea: Moderate
    1.3 (0.9 to 2.0)
    1.9 (1.4 to 2.5)
    2.0 (1.5 to 2.6)
    1.0 (0.6 to 1.5)
    1.2 (0.6 to 2.0)
    0.9 (0.4 to 1.6)
        Diarrhea: Severe
    0.2 (0.1 to 0.5)
    0.1 (0.0 to 0.3)
    0 (0.0 to 0.2)
    0.1 (0.0 to 0.3)
    0 (0.0 to 0.3)
    0 (0.0 to 0.3)
        Diarrhea: Grade 4
    0 (0.0 to 0.2)
    0 (0.0 to 0.1)
    0 (0.0 to 0.1)
    0 (0.0 to 0.2)
    0 (0.0 to 0.3)
    0 (0.0 to 0.3)
        New or worsened muscle pain: Mild
    9.1 (7.9 to 10.5)
    12.2 (11.0 to 13.4)
    7.9 (7.0 to 9.0)
    5.6 (4.6 to 6.7)
    11.1 (9.3 to 13.1)
    7.8 (6.3 to 9.5)
        New or worsened muscle pain: Moderate
    4.5 (3.6 to 5.5)
    10.2 (9.1 to 11.4)
    3.3 (2.7 to 4.0)
    2.6 (1.9 to 3.4)
    12.9 (11.0 to 15.0)
    5.3 (4.1 to 6.8)
        New or worsened muscle pain: Severe
    0.0 (0.0 to 0.3)
    0.5 (0.3 to 0.9)
    0.1 (0.0 to 0.2)
    0.2 (0.0 to 0.4)
    0.2 (0.0 to 0.6)
    0 (0.0 to 0.3)
        New or worsened muscle pain: Grade 4
    0 (0.0 to 0.2)
    0 (0.0 to 0.1)
    0 (0.0 to 0.1)
    0 (0.0 to 0.2)
    0 (0.0 to 0.3)
    0 (0.0 to 0.3)
        New or worsened joint pain: Mild
    5.9 (4.9 to 7.0)
    6.9 (6.0 to 7.9)
    3.9 (3.2 to 4.6)
    3.9 (3.1 to 4.9)
    5.9 (4.6 to 7.4)
    4.4 (3.3 to 5.8)
        New or worsened joint pain: Moderate
    2.6 (2.0 to 3.4)
    4.7 (4.0 to 5.6)
    1.9 (1.4 to 2.5)
    2.3 (1.7 to 3.0)
    3.7 (2.7 to 5.0)
    2.4 (1.6 to 3.5)
        New or worsened joint pain: Severe
    0.1 (0.0 to 0.4)
    0.2 (0.1 to 0.4)
    0 (0.0 to 0.2)
    0.1 (0.0 to 0.3)
    0.1 (0.0 to 0.5)
    0 (0.0 to 0.3)
        New or worsened joint pain: Grade 4
    0 (0.0 to 0.2)
    0 (0.0 to 0.1)
    0 (0.0 to 0.1)
    0 (0.0 to 0.2)
    0 (0.0 to 0.3)
    0 (0.0 to 0.3)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Systemic Events Within 7 Days After Dose 2: Phase 2/3

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    End point title
    		 Percentage of Subjects With Systemic Events Within 7 Days After Dose 2: Phase 2/3 [26]
    End point description
    Systemic events included fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain recorded by subjects or parents/legal guardians of subjects. Fever=temperature >=38.0 degrees C categorised as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0-degrees C. Fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain graded as mild (does not interfere with activity), moderate (some interference with activity), severe (prevents daily routine activity), Grade 4 (Emergency room visit/hospitalisation). Vomiting: mild (1-2 times in 24 hours[h]), moderate (more than 2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalisation for hypotensive shock). Diarrhea:mild (2 to 3 loose stools in 24h), moderate (4 to 5 loose stools in 24 h), severe (6 or more loose stools in 24 h) and Grade 4 (emergency room visit/hospitalisation). Safety population assessed.
    End point type
    Primary
    End point timeframe
    Within 7 Days after Dose 2
    Notes
    [26] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis performed for this endpoint
    End point values
    		 BNT162b2 (30 mcg): 56-85 Years BNT162b2 (30 mcg): 18-55 Years Placebo: 18-85 Years Placebo: 56-85 Years BNT162b2 (30 mcg): 12-15 years of age Placebo: 12-15 years of age
    Number of subjects analysed
    1860
    2682
    2684
    1833
    1097
    1078
    Units: Percentage of subjects
    number (confidence interval 95%)
        Fever: 38.0°C to 38.4°C
    8.5 (7.3 to 9.9)
    9.5 (8.4 to 10.6)
    0.2 (0.1 to 0.4)
    0.1 (0.0 to 0.4)
    9.8 (8.1 to 11.7)
    0.5 (0.2 to 1.1)
        Fever: >38.4°C to 38.9°C
    2.9 (2.2 to 3.8)
    5.4 (4.6 to 6.4)
    0.1 (0.0 to 0.4)
    0.1 (0.0 to 0.3)
    7.6 (6.1 to 9.3)
    0.1 (0.0 to 0.5)
        Fever: >38.9°C to 40.0°C
    0.4 (0.2 to 0.8)
    1.5 (1.0 to 2.0)
    0.1 (0.0 to 0.3)
    0.1 (0.0 to 0.3)
    2.3 (1.5 to 3.3)
    0.1 (0.0 to 0.5)
        Fever: >40.0°C
    0 (0.0 to 0.2)
    0.0 (0.0 to 0.2)
    0 (0.0 to 0.1)
    0 (0.0 to 0.2)
    0 (0.0 to 0.3)
    0 (0.0 to 0.3)
        Fatigue: Mild
    21.0 (19.2 to 22.9)
    20.8 (19.3 to 22.4)
    11.8 (10.6 to 13.1)
    10.0 (8.6 to 11.4)
    21.1 (18.8 to 23.7)
    12.3 (10.4 to 14.5)
        Fatigue: Moderate
    26.7 (24.7 to 28.8)
    35.4 (33.6 to 37.2)
    10.5 (9.4 to 11.8)
    6.6 (5.5 to 7.8)
    42.7 (39.7 to 45.7)
    11.8 (9.9 to 13.9)
        Fatigue: Severe
    3.2 (2.5 to 4.1)
    5.3 (4.5 to 6.2)
    0.5 (0.3 to 0.9)
    0.1 (0.0 to 0.4)
    2.4 (1.6 to 3.5)
    0.4 (0.1 to 0.9)
        Fatigue: Grade 4
    0.1 (0.0 to 0.3)
    0 (0.0 to 0.1)
    0 (0.0 to 0.1)
    0 (0.0 to 0.2)
    0 (0.0 to 0.3)
    0 (0.0 to 0.3)
        Headache: Mild
    24.9 (23.0 to 27.0)
    26.1 (24.4 to 27.8)
    15.1 (13.7 to 16.5)
    10.3 (9.0 to 11.8)
    27.5 (24.9 to 30.3)
    15.7 (13.6 to 18.0)
        Headache: Moderate
    26.7 (24.7 to 28.8)
    24.5 (22.9 to 26.2)
    8.6 (7.5 to 9.7)
    3.5 (2.7 to 4.5)
    35.0 (32.2 to 37.9)
    8.6 (7.0 to 10.5)
        Headache: Severe
    3.2 (2.5 to 4.1)
    3.4 (2.7 to 4.1)
    0.7 (0.4 to 1.1)
    0.3 (0.1 to 0.6)
    2.0 (1.3 to 3.0)
    0.1 (0.0 to 0.5)
        Headache: Grade 4
    0.1 (0.0 to 0.3)
    0 (0.0 to 0.1)
    0 (0.0 to 0.1)
    0 (0.0 to 0.2)
    0 (0.0 to 0.3)
    0 (0.0 to 0.3)
        Chills: Mild
    12.3 (10.9 to 13.9)
    17.8 (16.4 to 19.3)
    3.3 (2.7 to 4.1)
    2.5 (1.8 to 3.3)
    20.1 (17.8 to 22.6)
    4.8 (3.6 to 6.3)
        Chills: Moderate
    9.9 (8.6 to 11.4)
    17.5 (16.1 to 19.0)
    0.9 (0.5 to 1.3)
    0 (0.0 to 0.2)
    19.5 (17.2 to 22.0)
    1.9 (1.2 to 3.0)
        Chills: Severe
    1.1 (0.7 to 1.7)
    2.6 (2.0 to 3.2)
    0.1 (0.0 to 0.3)
    0 (0.0 to 0.2)
    1.8 (1.1 to 2.8)
    0 (0.0 to 0.3)
        Chills: Grade 4
    0 (0.0 to 0.2)
    0 (0.0 to 0.1)
    0 (0.0 to 0.1)
    0 (0.0 to 0.2)
    0 (0.0 to 0.3)
    0 (0.0 to 0.3)
        Vomiting: Mild
    0.5 (0.3 to 1.0)
    1.6 (1.1 to 2.1)
    0.7 (0.5 to 1.1)
    0.3 (0.1 to 0.6)
    2.3 (1.5 to 3.3)
    1.0 (0.5 to 1.8)
        Vomiting: Moderate
    0.1 (0.0 to 0.3)
    0.4 (0.2 to 0.8)
    0.4 (0.2 to 0.7)
    0 (0.0 to 0.2)
    0.4 (0.1 to 0.9)
    0.1 (0.0 to 0.5)
        Vomiting: Severe
    0.1 (0.0 to 0.4)
    0.1 (0.0 to 0.4)
    0 (0.0 to 0.1)
    0 (0.0 to 0.2)
    0 (0.0 to 0.3)
    0 (0.0 to 0.3)
        Vomiting: Grade 4
    0 (0.0 to 0.2)
    0 (0.0 to 0.1)
    0 (0.0 to 0.1)
    0 (0.0 to 0.2)
    0 (0.0 to 0.3)
    0 (0.0 to 0.3)
        Diarrhea: Mild
    6.7 (5.6 to 8.0)
    8.2 (7.2 to 9.3)
    6.3 (5.4 to 7.3)
    4.1 (3.3 to 5.2)
    5.4 (4.1 to 6.9)
    3.5 (2.5 to 4.8)
        Diarrhea: Moderate
    1.3 (0.9 to 2.0)
    1.6 (1.2 to 2.2)
    1.3 (0.9 to 1.8)
    1.2 (0.8 to 1.8)
    0.5 (0.2 to 1.2)
    0.5 (0.2 to 1.1)
        Diarrhea: Severe
    0.1 (0.0 to 0.4)
    0.2 (0.1 to 0.5)
    0.0 (0.0 to 0.2)
    0.2 (0.1 to 0.6)
    0 (0.0 to 0.3)
    0 (0.0 to 0.3)
        Diarrhea: Grade 4
    0 (0.0 to 0.2)
    0 (0.0 to 0.1)
    0 (0.0 to 0.1)
    0 (0.0 to 0.2)
    0 (0.0 to 0.3)
    0 (0.0 to 0.3)
        New or worsened muscle pain: Mild
    12.3 (10.9 to 13.9)
    16.4 (15.1 to 17.9)
    5.6 (4.7 to 6.5)
    3.5 (2.7 to 4.5)
    13.9 (11.9 to 16.0)
    4.7 (3.5 to 6.2)
        New or worsened muscle pain: Moderate
    15.5 (13.9 to 17.2)
    20.6 (19.1 to 22.2)
    3.1 (2.5 to 3.9)
    1.8 (1.2 to 2.5)
    18.0 (15.7 to 20.4)
    3.4 (2.4 to 4.7)
        New or worsened muscle pain: Severe
    1.1 (0.7 to 1.7)
    2.3 (1.8 to 3.0)
    0.1 (0.0 to 0.3)
    0.1 (0.0 to 0.3)
    0.5 (0.2 to 1.2)
    0.2 (0.0 to 0.7)
        New or worsened muscle pain: Grade 4
    0 (0.0 to 0.2)
    0 (0.0 to 0.1)
    0 (0.0 to 0.1)
    0 (0.0 to 0.2)
    0 (0.0 to 0.3)
    0 (0.0 to 0.3)
        New or worsened joint pain: Mild
    9.8 (8.5 to 11.3)
    10.9 (9.7 to 12.1)
    3.1 (2.4 to 3.8)
    2.4 (1.7 to 3.2)
    8.3 (6.7 to 10.1)
    2.8 (1.9 to 3.9)
        New or worsened joint pain: Moderate
    8.7 (7.4 to 10.0)
    11.9 (10.7 to 13.2)
    2.3 (1.7 to 2.9)
    1.5 (1.0 to 2.1)
    7.1 (5.7 to 8.8)
    1.9 (1.2 to 3.0)
        New or worsened joint pain: Severe
    0.5 (0.2 to 0.9)
    1.0 (0.7 to 1.5)
    0.1 (0.0 to 0.4)
    0.1 (0.0 to 0.3)
    0.4 (0.1 to 0.9)
    0 (0.0 to 0.3)
        New or worsened joint pain: Grade 4
    0 (0.0 to 0.2)
    0 (0.0 to 0.1)
    0 (0.0 to 0.1)
    0 (0.0 to 0.2)
    0 (0.0 to 0.3)
    0 (0.0 to 0.3)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: Phase 2/3

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    End point title
    		 Percentage of Subjects Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: Phase 2/3 [27]
    End point description
    An AE was any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 95% CI was based on the Clopper and Pearson method. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    From Dose 1 through 1 month after Dose 2
    Notes
    [27] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis performed for this endpoint
    End point values
    		 BNT162b2 (30 mcg): >=16 years of age BNT162b2 (30 mcg): 12-15 years of age Placebo: 12-15 years of age Placebo: >=16 years of age
    Number of subjects analysed
    21926
    1131
    1129
    21921
    Units: Percentage of subjects
        number (confidence interval 95%)
    30.2 (29.6 to 30.8)
    6.0 (4.7 to 7.6)
    5.9 (4.6 to 7.5)
    13.9 (13.4 to 14.4)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: Phase 2/3

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    End point title
    		 Percentage of Subjects Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: Phase 2/3 [28]
    End point description
    An SAE was any untoward medical occurrence that occurred, at any dose: resulted in death; required inpatient hospitalisation or prolongation of existing hospitalisation; was life-threatening; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect and other important medical events. 95% CI was based on the Clopper and Pearson method. Safety population include all randomised subjects who received at least 1 dose of the study intervention.
    End point type
    Primary
    End point timeframe
    From Dose 1 to 6 Months After Dose 2
    Notes
    [28] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis performed for this endpoint
    End point values
    		 BNT162b2 (30 mcg): 12-15 years of age Placebo: 12-15 years of age Placebo/BNT162b2 30 mcg: 12-15 years of age BNT162b2 30 mcg: >=16 years of age Placebo/BNT162b2 30 mcg: >=16 years of age Placebo: >=16 years of age
    Number of subjects analysed
    1131
    1129
    1014
    21910
    20267
    21911
    Units: Percentage of subjects
        number (confidence interval 95%)
    1.1 (0.6 to 2.0)
    0.2 (0.0 to 0.6)
    1.3 (0.7 to 2.2)
    2.0 (1.8 to 2.1)
    1.7 (1.6 to 1.9)
    1.3 (1.2 to 1.5)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Titers: Phase 1

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    End point title
    		 Geometric Mean Titers (GMTs) of Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Titers: Phase 1
    End point description
    GMTs of severe acute respiratory syndrome coronavirus 2 neutralizing titers were reported in this endpoint. SARS-CoV-2 neutralization assay - NT50 and SARS-CoV-2 neutralization assay - NT90 were evaluated. Dose 2 evaluable immunogenicity population included all eligible randomised subjects who received 2 doses of the vaccine to which they were randomly assigned, with Dose 2 received within the predefined window (within 19-42 days after Dose 1), have at least 1 valid and determinate immunogenicity result after Dose 2 from the blood collection within an appropriate window after Dose 2 (within 6-8 days after Dose 2 for Phase 1 and within 28-42 days after Dose 2 for Phase 2/3), and had no other important protocol deviations as determined by the clinician. -99999 to 999999 indicates that the 95% CI was not estimated as there were less/no subjects in the particular group.
    End point type
    Secondary
    End point timeframe
    7, 21 days after dose 1; 7, 14 days and 1, 6months after dose 2
    End point values
    		 BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b1 10 mcg dose, 65-85 years of age 30 mcg dose, 65-85 years of age B2 Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    11
    12
    12
    9
    12
    12
    9
    12
    12
    11
    11
    9
    7
    Units: Titers
    geometric mean (confidence interval 95%)
        NT50 titer: 7 days after dose 1
    10.0 (10.0 to 10.0)
    0 (-99999 to 99999)
    10.0 (10.0 to 10.0)
    10.0 (10.0 to 10.0)
    10.0 (10.0 to 10.0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    10.0 (10.0 to 10.0)
    10.0 (10.0 to 10.0)
    100.8 (45.7 to 222.3)
    10.0 (10.0 to 10.0)
    79.3 (50.6 to 124.5)
    79.3 (40.9 to 153.5)
    19.9 (11.7 to 33.9)
    155.7 (80.4 to 301.7)
    10.0 (10.0 to 10.0)
    0 (0 to 0)
        NT50 (titer): 21 days after dose 1
    12.7 (9.6 to 16.8)
    12.5 (9.0 to 17.5)
    28.6 (17.1 to 47.9)
    32.5 (17.0 to 62.4)
    10.0 (10.0 to 10.0)
    16.6 (9.8 to 27.9)
    18.9 (11.1 to 32.3)
    14.4 (10.1 to 20.4)
    10.0 (10.0 to 10.0)
    10.0 (10.0 to 10.0)
    12.5 (9.0 to 17.4)
    10.0 (10.0 to 10.0)
    10.0 (10.0 to 10.0)
    10.0 (10.0 to 10.0)
    11.2 (8.7 to 14.4)
    12.0 (9.0 to 16.0)
    10.0 (10.0 to 10.0)
    10.0 (10.0 to 10.0)
        NT50 (titer): 7 days after dose 2
    167.9 (112.5 to 253.5)
    160.3 (80.1 to 320.9)
    267.1 (172.9 to 412.7)
    0 (0 to 0)
    0 (0 to 0)
    169.0 (102.7 to 278.2)
    362.5 (256.9 to 511.6)
    360.9 (237.4 to 548.6)
    10.0 (10.0 to 10.0)
    178.7 (94.5 to 337.7)
    100.8 (45.7 to 222.3)
    10.0 (10.0 to 10.0)
    79.3 (50.6 to 124.5)
    79.3 (40.9 to 153.5)
    19.9 (11.7 to 33.9)
    155.7 (80.4 to 301.7)
    10.0 (10.0 to 10.0)
    10.0 (10.0 to 10.0)
        NT50 (titer): 14 days after dose 2
    180.1 (107.2 to 302.5)
    202.9 (123.4 to 333.4)
    437.0 (302.6 to 631.1)
    0 (0 to 0)
    0 (0 to 0)
    108.8 (54.7 to 216.5)
    292.1 (179.3 to 475.7)
    161.6 (109.3 to 238.8)
    10.0 (10.0 to 10.0)
    104.7 (43.7 to 250.5)
    105.5 (50.0 to 222.6)
    10.0 (10.0 to 10.0)
    111.1 (81.0 to 152.3)
    73.7 (32.8 to 165.6)
    28.5 (13.7 to 59.2)
    214.1 (105.9 to 433.2)
    10.0 (10.0 to 10.0)
    10.0 (10.0 to 10.0)
        NT50 (titer): 1 month after dose 2
    68.5 (41.8 to 112.0)
    161.2 (102.5 to 253.4)
    180.5 (108.4 to 300.7)
    0 (0 to 0)
    0 (0 to 0)
    105.3 (65.1 to 170.6)
    251.7 (143.5 to 441.4)
    143.6 (103.8 to 198.6)
    10.0 (10.0 to 10.0)
    125.3 (74.7 to 210.0)
    144.7 (70.3 to 298.1)
    10.0 (10.0 to 10.0)
    69.6 (43.0 to 112.7)
    49.6 (23.1 to 106.6)
    22.7 (11.3 to 45.3)
    152.3 (81.2 to 285.6)
    10.0 (10.0 to 10.0)
    10.0 (10.0 to 10.0)
        NT50 (titer): 6 months after dose 2
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.057 (0.045 to 0.073)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.052 (0.042 to 0.063)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
        NT90 (titer): 7 days after dose 1
    10.0 (10.0 to 10.0)
    0 (-99999 to 99999)
    10.0 (10.0 to 10.0)
    10.0 (10.0 to 10.0)
    10.0 (10.0 to 10.0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    10.0 (10.0 to 10.0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
        NT90 (titer): 21 days after dose 1
    10.0 (10.0 to 10.0)
    10.0 (10.0 to 10.0)
    11.9 (9.1 to 15.6)
    15.0 (9.3 to 24.4)
    10.0 (10.0 to 10.0)
    10.9 (9.0 to 13.2)
    10.7 (9.2 to 12.5)
    10.8 (9.1 to 12.8)
    10.0 (10.0 to 10.0)
    10.0 (10.0 to 10.0)
    10.0 (10.0 to 10.0)
    10.0 (10.0 to 10.0)
    10.0 (10.0 to 10.0)
    10.0 (10.0 to 10.0)
    10.0 (10.0 to 10.0)
    10.0 (10.0 to 10.0)
    10.0 (10.0 to 10.0)
    10.0 (10.0 to 10.0)
        NT90 (titer): 7 days after dose 2
    10.0 (10.0 to 10.0)
    0 (-99999 to 99999)
    10.0 (10.0 to 10.0)
    10.0 (10.0 to 10.0)
    10.0 (10.0 to 10.0)
    70.1 (42.7 to 115.0)
    142.2 (103.3 to 195.7)
    122.8 (79.2 to 190.4)
    10.0 (10.0 to 10.0)
    178.7 (94.5 to 337.7)
    47.6 (22.1 to 102.3)
    10.0 (10.0 to 10.0)
    40.0 (26.5 to 60.3)
    33.4 (18.1 to 61.4)
    12.1 (9.0 to 16.3)
    53.5 (26.1 to 109.4)
    10.0 (10.0 to 10.0)
    10.0 (10.0 to 10.0)
        NT90 (titer): 14 days after dose 2
    76.5 (44.4 to 131.6)
    110.4 (71.4 to 170.5)
    188.1 (126.4 to 279.8)
    0 (0 to 0)
    0 (0 to 0)
    46.6 (25.1 to 86.5)
    112.7 (73.9 to 171.8)
    54.3 (37.5 to 78.6)
    10.0 (10.0 to 10.0)
    49.0 (25.0 to 95.9)
    50.3 (25.4 to 99.5)
    10.0 (10.0 to 10.0)
    56.0 (35.4 to 88.6)
    29.3 (16.3 to 52.6)
    16.5 (9.6 to 28.1)
    60.3 (25.2 to 144.1)
    10.0 (10.0 to 10.0)
    10.0 (10.0 to 10.0)
        NT90 (titer): 1 month after dose 2
    37.0 (24.6 to 55.5)
    40.1 (25.0 to 64.3)
    62.0 (35.5 to 108.3)
    0 (0 to 0)
    0 (0 to 0)
    34.4 (18.4 to 64.7)
    60.0 (33.3 to 108.2)
    54.7 (41.2 to 72.6)
    10.0 (10.0 to 10.0)
    48.4 (26.0 to 90.2)
    59.9 (30.4 to 118.0)
    10.0 (10.0 to 10.0)
    20.2 (12.1 to 33.7)
    24.6 (12.9 to 47.0)
    14.2 (9.0 to 22.4)
    50.9 (28.3 to 91.6)
    10.0 (10.0 to 10.0)
    10.0 (10.0 to 10.0)
        NT90 (titer): 6 months after dose 2
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    No statistical analyses for this end point

    Secondary: Geometric Mean Concentrations (GMCs) of Severe Acute Respiratory Syndrome Coronavirus 2: S1-binding and RBD-binding IgG level assay: Phase 1

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    End point title
    		 Geometric Mean Concentrations (GMCs) of Severe Acute Respiratory Syndrome Coronavirus 2: S1-binding and RBD-binding IgG level assay: Phase 1
    End point description
    GMCs of severe acute respiratory syndrome coronavirus S1-binding and RBD-binding IgG level were reported in this endpoint. Dose 2 evaluable immunogenicity population included all eligible randomised subjects who received 2 doses of the vaccine to which they were randomly assigned, with Dose 2 received within the predefined window (within 19-42 days after Dose 1), have at least 1 valid and determinate immunogenicity result after Dose 2 from the blood collection within an appropriate window after Dose 2 (within 6-8 days after Dose 2 for Phase 1 and within 28-42 days after Dose 2 for Phase 2/3), and had no other important protocol deviations as determined by the clinician. -99999 to 999999 indicates that the 95% CI was not estimated as there were less/no subjects in the particular group.
    End point type
    Secondary
    End point timeframe
    7, 21 days after dose 1; 7, 14 days and 1, 6 months after dose 2
    End point values
    		 BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Units per milliliter
    number (confidence interval 95%)
        S1-binding IgG level assay:7 days after Dose1
    0.8 (0.5 to 1.1)
    0 (-99999 to 99999)
    0.9 (0.5 to 1.4)
    0.9 (0.4 to 1.9)
    0.6 (0.6 to 0.6)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 0)
    1.0 (0.5 to 2.2)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
        S1-binding IgG level assay: 21 days after Dose 1
    294.2 (126.8 to 682.8)
    204.1 (57.5 to 723.9)
    852.7 (479.5 to 1516.4)
    1074.4 (702.2 to 1643.9)
    0.6 (0.6 to 0.6)
    611.7 (332.0 to 1126.8)
    546.7 (346.3 to 863.1)
    1264.8 (912.6 to 1753.1)
    0.8 (0.4 to 1.6)
    34.1 (9.7 to 120.2)
    125.1 (56.2 to 278.4)
    86.3 (27.7 to 269.2)
    1.1 (0.6 to 2.3)
    172.0 (92.0 to 321.7)
    80.9 (31.7 to 206.8)
    283.2 (115.7 to 693.2)
    0.8 (0.6 to 1.2)
    0.6 (0.6 to 0.6)
        S1-binding IgG level assay:7 days after Dose 2
    3868.2 (2052.5 to 7290.0)
    3243.1 (689.9 to 15244.1)
    23516.5 (16552.7 to 33409.8)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    6014.0 (4061.6 to 8904.9)
    12464.0 (9249.2 to 16796.1)
    9136.4 (6385.0 to 13073.3)
    1.2 (0.5 to 2.7)
    860.7 (372.4 to 1989.3)
    10622.7 (5607.8 to 20122.3)
    6579.6 (2827.6 to 15310.2)
    1.3 (0.5 to 3.2)
    3203.3 (2314.5 to 4433.4)
    2734.2 (1211.8 to 6169.3)
    7547.9 (4224.0 to 13487.6)
    0.9 (0.6 to 1.5)
    0.6 (0.6 to 0.6)
        S1-binding IgG level assay:14 days after Dose 2
    5120.2 (3529.2 to 7428.5)
    7480.5 (4670.8 to 11980.2)
    13940.1 (9746.7 to 19937.5)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    4757.7 (2926.8 to 7733.9)
    7366.9 (4774.3 to 11367.4)
    7639.4 (6308.6 to 9251.1)
    0.9 (0.5 to 1.9)
    1436.6 (760.1 to 2715.0)
    6399.4 (3481.6 to 11762.3)
    4798.4 (2209.3 to 10421.9)
    0.9 (0.5 to 1.7)
    3560.2 (2282.4 to 5553.5)
    2522.7 (1182.4 to 5382.1)
    5844.0 (3620.4 to 9433.3)
    0.8 (0.6 to 1.1)
    0.6 (0.6 to 0.6)
        S1-binding IgG level assay:1Month after Dose 2
    2530.8 (1684.3 to 3802.5)
    5329.2 (3789.4 to 7494.7)
    8095.2 (5563.4 to 11779.1)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    3098.6 (2088.1 to 4598.0)
    5784.7 (4131.4 to 8099.8)
    5296.0 (4139.6 to 6775.4)
    0.9 (0.5 to 1.7)
    1089.8 (556.7 to 2133.4)
    5138.2 (2788.0 to 9469.5)
    4151.0 (1872.9 to 9200.2)
    1.2 (0.6 to 2.6)
    2350.5 (1787.1 to 3091.7)
    1491.5 (682.0 to 3262.0)
    4592.4 (2874.1 to 7337.9)
    0.8 (0.5 to 1.3)
    0.8 (0.5 to 1.2)
        S1-binding IgG level assay:6Months after Dose 2
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    960.8 (483.8 to 1908.1)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    559.6 (363.0 to 862.8)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
        RBD-binding IgG level assay:7 days after Dose1
    0.9 (0.5 to 1.6)
    0 (-99999 to 99999)
    0.8 (0.5 to 1.5)
    1.2 (0.6 to 2.6)
    0.8 (0.2 to 3.2)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0.9 (0.4 to 2.1)
    0 (-99999 to 99999)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
        RBD-binding IgG level assay:21 days after Dose1
    534.4 (244.1 to 1169.6)
    362.5 (89.5 to 1468.4)
    1535.9 (938.1 to 2514.6)
    1778.3 (1218.9 to 2594.7)
    0.9 (0.1 to 5.0)
    338.9 (172.6 to 665.4)
    347.2 (223.0 to 540.4)
    862.3 (581.2 to 1279.5)
    0.8 (0.5 to 1.6)
    61.2 (17.1 to 218.9)
    234.4 (102.9 to 533.9)
    99.2 (30.3 to 324.3)
    1.2 (0.4 to 3.6)
    83.6 (26.6 to 262.6)
    50.9 (16.7 to 155.2)
    198.6 (67.6 to 583.5)
    1.0 (0.5 to 2.1)
    0.9 (0.5 to 1.6)
        RBD-binding IgG level assay:7 days after Dose 2
    4813.1 (2479.5 to 9343.1)
    4033.8 (832.8 to 19538.0)
    27871.8 (19430.0 to 39981.4)
    0 (0 to 0)
    0 (-99999 to 99999)
    4926.8 (3239.2 to 7493.7)
    12258.1 (8875.8 to 16929.4)
    7759.7 (5537.3 to 10874.0)
    0.9 (0.5 to 1.5)
    1283.5 (535.2 to 3078.4)
    12932.8 (7091.0 to 23587.3)
    7527.5 (3564.2 to 15897.7)
    1.4 (0.4 to 5.0)
    2521.8 (1642.3 to 3872.3)
    2567.2 (979.5 to 6728.1)
    5877.3 (3426.5 to 10080.9)
    1.1 (0.5 to 2.6)
    0.9 (0.5 to 1.6)
        RBD-binding IgG level assay:14 days after Dose 2
    5880.4 (4249.8 to 8136.8)
    6376.7 (4314.0 to 9425.7)
    16165.9 (11013.3 to 23729.2)
    0 (0 to 0)
    0 (-99999 to 99999)
    3984.8 (2278.2 to 6969.9)
    6383.2 (4422.7 to 9212.7)
    6825.6 (5103.5 to 9129.0)
    0.7 (0.5 to 1.0)
    1771.9 (947.6 to 3313.3)
    6983.1 (3878.5 to 12573.1)
    6006.5 (2821.3 to 12787.6)
    1.4 (0.4 to 4.2)
    2941.7 (1915.7 to 4517.2)
    1734.0 (775.0 to 3879.8)
    5642.0 (3343.2 to 9518.5)
    1.0 (0.5 to 2.2)
    0.9 (0.5 to 1.7)
        RBD-binding IgG level assay:1Month after Dose 2
    3674.2 (2595.4 to 5201.4)
    6215.2 (4312.8 to 8956.8)
    9489.6 (6258.7 to 14388.4)
    0 (0 to 0)
    0 (-99999 to 99999)
    2612.6 (1711.1 to 3989.0)
    4183.7 (3011.7 to 5811.6)
    5059.8 (3974.2 to 6442.0)
    0.7 (0.4 to 1.3)
    1495.4 (825.3 to 2709.5)
    5641.9 (3114.1 to 10221.3)
    4488.5 (2131.3 to 9452.6)
    1.2 (0.4 to 4.0)
    2214.5 (1631.6 to 3005.7)
    1272.1 (540.7 to 2993.2)
    3468.6 (1998.4 to 6020.4)
    0.9 (0.4 to 1.9)
    1.0 (0.5 to 2.3)
        RBD-binding IgG level assay:6Months after Dose 2
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (-99999 to 99999)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralising Titers: Phase 1

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    End point title
    		 Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralising Titers: Phase 1
    End point description
    GMFR of SARS-CoV-2 neutralising titers were reported in this endpoint. Dose 2 evaluable immunogenicity population included all eligible randomised subjects who received 2 doses of the vaccine to which they were randomly assigned, with Dose 2 received within the predefined window (within 19-42 days after Dose 1), have at least 1 valid and determinate immunogenicity result after Dose 2 from the blood collection within an appropriate window after Dose 2 (within 6-8 days after Dose 2 for Phase 1 and within 28-42 days after Dose 2 for Phase 2/3), and had no other important protocol deviations as determined by the clinician. -99999 to 999999 indicates that the 95% CI was not estimated as there were less/no subjects in the particular group.
    End point type
    Secondary
    End point timeframe
    7, 21 days after dose 1; 7, 14 days and 1, 6 months after dose 2
    End point values
    		 BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    11
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Fold rise
    geometric mean (confidence interval 95%)
        NT50 titer: 7 days after dose 1
    1.0 (1.0 to 1.0)
    0 (-99999 to 99999)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    0 (-99999 to 99999)
    0 (0 to 0)
    0 (0 to 0)
    1.0 (1.0 to 1.0)
    0 (-99999 to 99999)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
        NT50 (titer): 21 days after dose 1
    1.3 (1.0 to 1.7)
    1.3 (0.9 to 1.8)
    2.9 (1.7 to 4.8)
    3.3 (1.7 to 6.2)
    1.0 (1.0 to 1.0)
    1.7 (1.0 to 2.8)
    1.9 (1.1 to 3.2)
    1.4 (1.0 to 2.0)
    1.0 (1.0 to 1.0)
    1.1 (0.9 to 1.4)
    1.0 (1.0 to 1.0)
    1.2 (0.9 to 1.7)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.2 (0.9 to 1.6)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
        NT50 (titer): 7 days after dose 2
    16.8 (11.1 to 25.3)
    16.0 (8.0 to 32.1)
    26.7 (17.3 to 41.3)
    0 (0 to 0)
    0 (0 to 0)
    16.9 (10.3 to 27.8)
    36.3 (25.7 to 51.2)
    36.1 (23.7 to 54.9)
    1.0 (1.0 to 1.0)
    2.0 (1.2 to 3.4)
    17.9 (9.5 to 33.8)
    10.1 (4.6 to 22.2)
    1.0 (1.0 to 1.0)
    7.9 (5.1 to 12.4)
    7.9 (4.1 to 15.3)
    15.6 (8.0 to 30.2)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
        NT50 (titer): 14days after dose 2
    18.0 (10.7 to 30.3)
    20.3 (12.3 to 33.3)
    43.7 (30.3 to 63.1)
    0 (0 to 0)
    0 (0 to 0)
    10.9 (5.5 to 21.7)
    29.2 (17.9 to 47.6)
    16.2 (10.9 to 23.9)
    1.0 (1.0 to 1.0)
    2.8 (1.4 to 5.9)
    10.5 (4.4 to 25.0)
    10.5 (5.0 to 22.3)
    1.0 (1.0 to 1.0)
    11.1 (8.1 to 15.2)
    7.4 (3.3 to 16.6)
    21.4 (10.6 to 43.3)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
        NT50 (titer): 1 month after dose 2
    6.8 (4.2 to 11.2)
    16.1 (10.3 to 25.3)
    18.1 (10.8 to 30.1)
    0 (0 to 0)
    0 (0 to 0)
    10.5 (6.5 to 17.1)
    25.2 (14.3 to 44.1)
    14.4 (10.4 to 19.9)
    1.0 (1.0 to 1.0)
    2.3 (1.1 to 4.5)
    12.5 (7.5 to 21.0)
    14.5 (7.0 to 29.8)
    1.0 (1.0 to 1.0)
    7.0 (4.3 to 11.3)
    5.0 (2.3 to 10.7)
    15.2 (8.1 to 28.6)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
        NT50 (titer): 6 months after dose 2
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    5.5 (2.5 to 12.1)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    2.9 (1.9 to 4.3)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
        NT90 (titer): 7 days after dose 1
    1.0 (1.0 to 1.0)
    0 (-99999 to 99999)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    1.0 (1.0 to 1.0)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
        NT90 (titer): 21 days after dose 1
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.2 (0.9 to 1.6)
    1.5 (0.9 to 2.4)
    1.0 (1.0 to 1.0)
    1.1 (0.9 to 1.3)
    1.1 (0.9 to 1.2)
    1.1 (0.9 to 1.3)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
        NT90 (titer): 7 days after dose 2
    5.7 (3.5 to 9.1)
    6.7 (4.0 to 11.1)
    12.2 (7.9 to 18.8)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    7.0 (4.3 to 11.5)
    14.2 (10.3 to 19.6)
    12.3 (7.9 to 19.0)
    1.0 (1.0 to 1.0)
    1.2 (0.9 to 1.6)
    7.4 (3.5 to 15.7)
    4.8 (2.2 to 10.2)
    1.0 (1.0 to 1.0)
    4.0 (2.7 to 6.0)
    3.3 (1.8 to 6.1)
    5.3 (2.6 to 10.9)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
        NT90 (titer): 14 days after dose 2
    7.6 (4.4 to 13.2)
    11.0 (7.1 to 17.1)
    18.8 (12.6 to 28.0)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    4.7 (2.5 to 8.7)
    11.3 (7.4 to 17.2)
    5.4 (3.8 to 7.9)
    1.0 (1.0 to 1.0)
    1.6 (1.0 to 2.8)
    4.9 (2.5 to 9.6)
    5.0 (2.5 to 10.0)
    1.0 (1.0 to 1.0)
    5.6 (3.5 to 8.9)
    2.9 (1.6 to 5.3)
    6.0 (2.5 to 14.4)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
        NT90 (titer): 1 month after dose 2
    3.7 (2.5 to 5.5)
    4.0 (2.5 to 6.4)
    6.2 (3.5 to 10.8)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    3.4 (1.8 to 6.5)
    6.0 (3.3 to 10.8)
    5.5 (4.1 to 7.3)
    1.0 (1.0 to 1.0)
    1.4 (0.9 to 2.2)
    4.8 (2.6 to 9.0)
    6.0 (3.0 to 11.8)
    1.0 (1.0 to 1.0)
    2.0 (1.2 to 3.4)
    2.5 (1.3 to 4.7)
    5.1 (2.8 to 9.2)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.0)
        NT90 (titer): 6 months after dose 2
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
    0 (0 to 0)
    0 (-99999 to 99999)
    No statistical analyses for this end point

    Secondary: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 S1-binding and RBD-binding IgG level assay: Phase 1

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    End point title
    		 Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 S1-binding and RBD-binding IgG level assay: Phase 1
    End point description
    GMFR of S1-binding and RBD-binding IgG level assay were reported in this endpoint. Dose 2 evaluable immunogenicity population included all eligible randomised subjects who received 2 doses of the vaccine to which they were randomly assigned, with Dose 2 received within the predefined window (within 19-42 days after Dose 1), have at least 1 valid and determinate immunogenicity result after Dose 2 from the blood collection within an appropriate window after Dose 2 (within 6-8 days after Dose 2 for Phase 1 and within 28-42 days after Dose 2 for Phase 2/3), and had no other important protocol deviations as determined by the clinician. -99999 to 999999 indicates that the 95% CI was not estimated as there were less/no subjects in the particular group.
    End point type
    Secondary
    End point timeframe
    7, 21 days after dose 1; 7, 14 days and 1, 6 months after dose 2
    End point values
    		 BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Fold rise
    geometric mean (confidence interval 95%)
        S1-binding IgG level assay:7days after dose1
    1.0 (1.0 to 1.0)
    0 (-99999 to 99999)
    1.1 (0.8 to 1.3)
    1.1 (0.9 to 1.5)
    1.0 (1.0 to 1.0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0.8 (0.5 to 1.4)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
        S1-binding IgG level assay:21days after dose1
    387.6 (182.9 to 821.1)
    271.3 (77.3 to 951.6)
    1027.5 (543.5 to 1942.4)
    1378.3 (718.0 to 2645.9)
    1.0 (1.0 to 1.0)
    965.9 (524.4 to 1779.4)
    636.8 (296.9 to 1365.6)
    1997.4 (1441.1 to 2768.4)
    0.9 (0.7 to 1.1)
    34.4 (7.3 to 161.9)
    162.6 (81.8 to 323.1)
    124.8 (41.4 to 376.3)
    1.0 (1.0 to 1.1)
    223.5 (112.1 to 445.8)
    98.2 (36.4 to 265.2)
    447.2 (182.6 to 1094.7)
    1.0 (1.0 to 1.1)
    0.0 (0.0 to 41.0)
        S1-binding IgG level assay:7days after dose2
    5095.8 (2819.1 to 9211.0)
    4311.2 (899.3 to 20668.6)
    28336.5 (17881.6 to 44904.3)
    0 (0 to 0)
    0 (0 to 0)
    9497.1 (6413.9 to 14062.2)
    14516.5 (9188.0 to 22935.3)
    14427.7 (10082.9 to 20644.7)
    1.3 (0.9 to 1.8)
    868.3 (276.9 to 2722.5)
    13807.8 (7573.0 to 25175.6)
    9516.4 (4262.5 to 21246.3)
    1.2 (0.9 to 1.6)
    4162.5 (2679.8 to 6465.4)
    3240.5 (1349.3 to 7782.7)
    11919.3 (6670.3 to 21299.0)
    1.2 (0.9 to 1.6)
    0.0 (0.0 to 41.0)
        S1-binding IgG level assay:14days after dose2
    6745.2 (4430.5 to 10269.0)
    9944.3 (5315.2 to 18604.8)
    16797.3 (10604.5 to 26606.6)
    0 (0 to 0)
    0 (0 to 0)
    7513.2 (4621.9 to 12213.0)
    8580.1 (5164.3 to 14255.0)
    12063.8 (9962.2 to 14608.8)
    1.0 (0.9 to 1.0)
    1449.3 (521.4 to 4028.2)
    8318.2 (4793.1 to 14435.8)
    6940.3 (3323.6 to 14492.3)
    0.8 (0.6 to 1.1)
    4545.1 (2529.5 to 8166.6)
    2989.8 (1255.2 to 7121.5)
    9228.6 (5717.2 to 14896.6)
    1.0 (0.9 to 1.1)
    0.0 (0.0 to 41.0)
        S1-binding IgG level assay:1month after dose2
    3333.9 (2382.9 to 4664.5)
    7084.4 (4443.5 to 11295.0)
    9754.4 (5820.9 to 16346.0)
    0 (0 to 0)
    0 (0 to 0)
    4893.1 (3297.4 to 7261.0)
    6553.4 (3787.8 to 11338.5)
    8363.2 (6537.1 to 10699.5)
    0.9 (0.8 to 1.0)
    1099.4 (364.6 to 3314.9)
    6678.8 (3844.9 to 11601.5)
    6003.8 (2793.3 to 12904.6)
    1.1 (0.9 to 1.4)
    3054.4 (2015.9 to 4627.9)
    1767.7 (700.5 to 4460.6)
    7252.1 (4538.7 to 11587.7)
    1.0 (0.6 to 1.7)
    0.0 (0.0 to 41.0)
        S1-binding IgG level assay:6months after dose2
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    1517.2 (764.0 to 3013.2)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    883.7 (573.2 to 1362.5)
    0 (-99999 to 99999)
    0 (-99999 to 99999)
        RBD-binding IgG level assay:7days after dose1
    1.1 (0.8 to 1.4)
    0 (-99999 to 99999)
    1.0 (0.9 to 1.0)
    1.3 (1.0 to 1.8)
    1.4 (0.3 to 5.6)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    1.0 (0.6 to 1.7)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0.0 (0.0 to 41.0)
        RBD-binding IgG level assay:21days after dose1
    640.7 (321.9 to 1275.0)
    292.9 (71.9 to 1193.1)
    1763.1 (930.9 to 3339.4)
    1966.5 (1039.6 to 3719.6)
    1.5 (0.3 to 8.7)
    516.9 (230.3 to 1160.4)
    557.1 (347.7 to 892.7)
    821.1 (456.9 to 1475.9)
    1.1 (0.8 to 1.6)
    44.4 (9.3 to 212.1)
    407.4 (178.8 to 928.2)
    159.6 (49.1 to 518.9)
    1.0 (0.9 to 1.0)
    89.6 (30.5 to 263.0)
    62.9 (17.4 to 227.0)
    316.3 (116.5 to 858.6)
    1.2 (0.7 to 2.2)
    0.0 (0.0 to 41.0)
        RBD-binding IgG level assay:7days after dose2
    5770.9 (2945.0 to 11308.3)
    3258.8 (646.1 to 16436.3)
    31996.2 (16410.0 to 62386.2)
    0 (0 to 0)
    0 (0 to 0)
    7514.3 (4609.8 to 12249.0)
    19671.3 (12848.3 to 30117.6)
    8442.8 (4885.5 to 14590.4)
    1.1 (0.7 to 1.8)
    931.4 (217.9 to 3982.1)
    22482.1 (12326.8 to 41003.5)
    12115.3 (5507.4 to 26651.4)
    1.1 (0.9 to 1.4)
    2703.3 (1629.0 to 4486.1)
    3070.3 (905.7 to 10408.5)
    9357.1 (6075.0 to 14412.3)
    1.4 (0.7 to 2.8)
    0.0 (0.0 to 41.0)
        RBD-binding IgG level assay:14days after dose2
    7050.6 (4405.1 to 11284.8)
    5151.7 (2469.6 to 10747.0)
    18558.1 (9354.8 to 36815.6)
    0 (0 to 0)
    0 (0 to 0)
    6077.6 (3328.1 to 11098.6)
    10243.4 (6509.5 to 16119.2)
    8213.0 (5507.4 to 12247.7)
    0.9 (0.7 to 1.2)
    1285.8 (329.7 to 5015.2)
    12139.3 (6742.2 to 21856.7)
    9667.2 (4456.0 to 20972.9)
    1.1 (0.8 to 1.5)
    3017.9 (1697.6 to 5364.9)
    2073.9 (698.9 to 6153.9)
    8982.5 (5966.6 to 13522.8)
    1.2 (0.6 to 2.6)
    0.0 (0.0 to 41.0)
        RBD-binding IgG level assay:1month after dose2
    4405.3 (2727.7 to 7114.7)
    5021.3 (2410.1 to 10461.6)
    10893.9 (5125.4 to 23154.7)
    0 (0 to 0)
    0 (0 to 0)
    3984.7 (2412.4 to 6581.7)
    6665.1 (4292.1 to 10350.2)
    5505.3 (3394.8 to 8927.8)
    1.0 (0.8 to 1.1)
    1085.2 (274.9 to 4283.7)
    9807.7 (5413.5 to 17768.4)
    7224.1 (3355.8 to 15551.5)
    1.0 (0.9 to 1.1)
    2373.9 (1454.3 to 3875.1)
    1521.5 (511.7 to 4523.9)
    5522.3 (3610.4 to 8446.6)
    1.3 (0.6 to 2.8)
    0.0 (0.0 to 41.0)
        RBD-binding IgG level assay:6months after dose2
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving a >= 4-Fold Rise From Before Vaccination to After Vaccination: Neutralising Titers: Phase 1

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    End point title
    		 Percentage of Subjects Achieving a >= 4-Fold Rise From Before Vaccination to After Vaccination: Neutralising Titers: Phase 1
    End point description
    Percentage of subjects that achieved >=4-fold rise from before vaccination to after vaccination were reported in this endpoint. -99999 to 999999 indicates that the 95% CI was not estimated as there were less/no subjects in the particular group.
    End point type
    Secondary
    End point timeframe
    7, 21 days after dose 1; 7, 14 days and 1, 6 months after dose 2
    End point values
    		 BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b1 10 mcg dose, 65-85 years of age 30 mcg dose, 65-85 years of age B2 Placebo: 18-55 years of age for BNT162b1 Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    11
    12
    12
    12
    12
    9
    12
    12
    11
    11
    6
    9
    9
    Units: Percentage of subjects
    number (confidence interval 95%)
        NT50 titer: 7 days after dose 1
    0.0 (0.0 to 26.5)
    0 (-99999 to 99999)
    0.0 (0.0 to 26.5)
    0.0 (0.0 to 26.5)
    0.0 (0.0 to 70.8)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    90.9 (58.7 to 99.8)
    0.0 (0.0 to 45.9)
    0 (0.0 to 33.6)
    0.0 (0.0 to 41.0)
        NT50 (titer): 21 days after dose 1
    0.0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    25.0 (5.5 to 57.2)
    50.0 (21.1 to 78.9)
    0.0 (0.0 to 70.8)
    18.2 (2.3 to 51.8)
    25.0 (5.5 to 57.2)
    0.0 (0.0 to 26.5)
    0.0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0 (0.0 to 33.6)
    0 (0.0 to 26.5)
    0 (0.0 to 26.5)
    0.0 (0.0 to 28.5)
    0 (0.0 to 28.5)
    0.0 (0.0 to 33.6)
    0 (0.0 to 33.6)
    0 (0.0 to 41.0)
        NT50 (titer): 7 days after dose 2
    91.7 (61.5 to 99.8)
    91.7 (61.5 to 99.8)
    100.0 (73.5 to 100.0)
    0 (0 to 0)
    0 (0 to 0)
    100.0 (71.5 to 100.0)
    100.0 (73.5 to 100.0)
    100.0 (71.5 to 100.0)
    91.7 (61.5 to 99.8)
    75.0 (42.8 to 94.5)
    0.0 (0.0 to 33.6)
    83.3 (51.6 to 97.9)
    81.8 (48.2 to 97.7)
    9.1 (0.2 to 41.3)
    90.9 (58.7 to 99.8)
    0 (0.0 to 33.6)
    0.0 (0.0 to 33.6)
    0.0 (0.0 to 41.0)
        NT50 (titer): 14days after dose 2
    91.7 (61.5 to 99.8)
    100.0 (73.5 to 100.0)
    100.0 (73.5 to 100.0)
    0 (0 to 0)
    0 (0 to 0)
    45.5 (16.7 to 76.6)
    91.7 (61.5 to 99.8)
    66.7 (29.9 to 92.5)
    75.0 (42.8 to 94.5)
    83.3 (51.6 to 97.9)
    0.0 (0.0 to 33.6)
    100.0 (71.5 to 100.0)
    72.7 (39.0 to 94.0)
    36.4 (10.9 to 69.2)
    100.0 (71.5 to 100.0)
    0.0 (0.0 to 33.6)
    0.0 (0.0 to 33.6)
    0.0 (0.0 to 41.0)
        NT50 (titer): 1 month after dose 2
    83.3 (51.6 to 97.9)
    100.0 (73.5 to 100.0)
    91.7 (61.5 to 99.8)
    0 (0 to 0)
    0 (0 to 0)
    100.0 (71.5 to 100.0)
    100.0 (71.5 to 100.0)
    100.0 (71.5 to 100.0)
    91.7 (61.5 to 99.8)
    81.3 (51.6 to 97.9)
    0 (0.0 to 33.6)
    75.0 (42.8 to 94.5)
    54.5 (23.4 to 83.3)
    18.2 (2.3 to 51.8)
    100.0 (71.5 to 100.0)
    0 (0.0 to 33.6)
    0.0 (0.0 to 36.9)
    0.0 (0.0 to 41.0)
        NT50 (titer): 6 months after dose 2
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0 (0 to 0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    60.0 (26.2 to 87.8)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    27.3 (6.0 to 61.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
        NT90 (titer): 7 days after dose 1
    0.0 (0.0 to 26.5)
    0 (-99999 to 99999)
    0.0 (0.0 to 26.5)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0.6)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0.0 (0.0 to 45.9)
    0 (0 to 0)
    0.0 (0.0 to 41.0)
        NT90 (titer): 21 days after dose 1
    0 (0.0 to 26.5)
    0.0 (0.0 to 26.5)
    0.0 (0.0 to 26.5)
    0 (0 to 0)
    0 (0 to 0)
    0.0 (0.0 to 28.5)
    0.0 (0.0 to 26.5)
    0.0 (0.0 to 26.5)
    0.0 (0.0 to 26.5)
    0.0 (0.0 to 26.5)
    0.0 (0.0 to 33.6)
    0.0 (0.0 to 26.5)
    0.0 (0.0 to 26.5)
    0.0 (0.0 to 28.5)
    0.0 (0.0 to 28.5)
    0.0 (0.0 to 33.6)
    0 (0.0 to 33.6)
    0.0 (0.0 to 41.0)
        NT90 (titer): 7 days after dose 2
    83.3 (51.6 to 97.9)
    81.8 (48.2 to 97.7)
    91.7 (61.5 to 99.8)
    0 (0 to 0)
    0 (0 to 0)
    81.8 (48.2 to 97.7)
    100.0 (73.5 to 100.0)
    100.0 (71.5 to 100.0)
    66.7 (34.9 to 90.1)
    58.3 (27.7 to 84.8)
    0 (0.0 to 33.6)
    41.7 (15.2 to 72.3)
    45.5 (16.7 to 76.6)
    0.0 (0.0 to 28.5)
    63.6 (30.8 to 89.1)
    0.0 (0.0 to 33.6)
    0 (0.0 to 33.6)
    0.0 (0.0 to 41.0)
        NT90 (titer): 14 days after dose 2
    83.3 (51.6 to 97.9)
    91.7 (61.5 to 99.8)
    100.0 (73.5 to 100.0)
    0 (0 to 0)
    0 (0 to 0)
    45.5 (16.7 to 76.6)
    91.7 (61.5 to 99.8)
    66.7 (29.9 to 92.5)
    58.3 (27.7 to 84.8)
    63.6 (30.8 to 89.1)
    0 (0.0 to 33.6)
    81.8 (48.2 to 97.7)
    27.3 (6.0 to 61.0)
    18.2 (2.3 to 51.8)
    60.0 (26.2 to 87.8)
    0.0 (0.0 to 33.6)
    0 (0.0 to 33.6)
    0.0 (0.0 to 41.0)
        NT90 (titer): 1 month after dose 2
    41.7 (15.2 to 72.3)
    54.5 (23.4 to 83.3)
    63.6 (30.8 to 89.1)
    0 (0 to 0)
    0 (0 to 0)
    45.5 (16.7 to 76.6)
    81.8 (48.2 to 97.7)
    72.7 (39.0 to 94.0)
    66.7 (34.9 to 90.1)
    66.7 (34.9 to 90.1)
    0 (0.0 to 33.6)
    16.7 (2.1 to 48.4)
    27.3 (6.0 to 61.0)
    9.1 (0.2 to 41.3)
    63.6 (30.8 to 89.1)
    0.0 (0.0 to 33.6)
    0 (0.0 to 36.9)
    0.0 (0.0 to 41.0)
        NT90 (titer): 6 months after dose 2
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0 (0 to 0)
    0 (0 to 0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Achieving a >= 4-Fold Rise From Before Vaccination to After Vaccination: S1-binding and RBD-binding IgG level assay: Phase 1

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    End point title
    		 Percentage of Subjects Achieving a >= 4-Fold Rise From Before Vaccination to After Vaccination: S1-binding and RBD-binding IgG level assay: Phase 1
    End point description
    End point type
    Secondary
    End point timeframe
    7, 21 days after dose 1; 7, 14 days and 1, 6 months after dose 2
    End point values
    		 BNT162b1 10 mcg dose: 18-55 years of age BNT162b1 20 mcg dose: 18-55 years of age BNT162b1 30 mcg dose: 18-55 years of age BNT162b1 100 mcg dose, 18-55 years of age Placebo 18-55 Years of Age for BNT162b1 100 mcg BNT162b2 10 mcg dose, 18-55 years of age BNT162b2 20 mcg dose, 18-55 years of age BNT162b2 30 mcg dose, 18-55 years of age Placebo: 18-55 years of age for BNT162b1 BNT162b1 10 mcg dose, 65-85 years of age BNT162b1 20 mcg dose, 65-85 years of age BNT162b1 30 mcg dose, 65-85 years of age Placebo, 65-85 years of age for BNT162b1 BNT162b2 10 mcg dose, 65-85 years of age BNT162b2 20 mcg dose, 65-85 years of age BNT162b2 30 mcg dose, 65-85 years of age Placebo: 65-85 years of age for BNT162b2 Placebo: 18-55 years of age for BNT162b2
    Number of subjects analysed
    12
    12
    12
    12
    3
    12
    12
    12
    9
    12
    12
    12
    9
    12
    12
    12
    9
    9
    Units: Units per milliliter
    number (confidence interval 95%)
        S1-binding IgG level assay:7days after dose1
    0.0 (0.0 to 26.5)
    0 (-99999 to 99999)
    0.0 (0.0 to 26.5)
    0.0 (0.0 to 26.5)
    0.0 (0.0 to 70.8)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0.0 (0.0 to 33.6)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
        S1-binding IgG level assay:21days after dose1
    100.0 (73.5 to 100.0)
    91.7 (61.5 to 99.8)
    100.0 (73.5 to 100.0)
    50.0 (21.1 to 78.9)
    0.0 (0.0 to 70.8)
    100.0 (71.5 to 100.0)
    100.0 (73.5 to 100.0)
    100.0 (73.5 to 100.0)
    0.0 (0.0 to 33.6)
    72.7 (39.0 to 94.0)
    100.0 (73.5 to 100.0)
    100.0 (73.5 to 100.0)
    0.0 (0.0 to 33.6)
    100.0 (73.5 to 100.0)
    91.7 (61.5 to 99.8)
    100.0 (71.5 to 100.0)
    0.0 (0.0 to 33.6)
    0.0 (0.0 to 41.0)
        S1-binding IgG level assay:7days after dose2
    100.0 (73.5 to 100.0)
    91.7 (61.5 to 91.8)
    100.0 (73.5 to 100.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    100.0 (71.5 to 100.0)
    100.0 (73.5 to 100.0)
    100.0 (71.5 to 100.0)
    0.0 (0.0 to 33.6)
    100.0 (71.5 to 100.0)
    100.0 (73.5 to 100.0)
    100.0 (73.5 to 100.0)
    0.0 (0.0 to 33.6)
    100.0 (73.5 to 100.0)
    100.0 (71.5 to 100.0)
    100.0 (71.5 to 100.0)
    0.0 (0.0 to 33.6)
    0.0 (0.0 to 41.0)
        S1-binding IgG level assay:14days after dose2
    100.0 (73.5 to 100.0)
    100.0 (73.5 to 100.0)
    100.0 (73.5 to 100.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    100.0 (71.5 to 100.0)
    100.0 (73.5 to 100.0)
    100.0 (66.4 to 100.0)
    0.0 (0.0 to 33.6)
    100.0 (71.5 to 100.0)
    100.0 (73.5 to 100.0)
    100.0 (73.5 to 100.0)
    0.0 (0.0 to 33.6)
    100.0 (71.5 to 100.0)
    100.0 (71.5 to 100.0)
    100.0 (71.5 to 100.0)
    0.0 (0.0 to 33.6)
    0.0 (0.0 to 41.0)
        S1-binding IgG level assay:1month after dose2
    100.0 (73.5 to 100.0)
    100.0 (73.5 to 100.0)
    100.0 (73.5 to 100.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    100.0 (71.5 to 100.0)
    100.0 (71.5 to 100.0)
    100.0 (71.5 to 100.0)
    0.0 (0.0 to 33.6)
    100.0 (71.5 to 100.0)
    100.0 (73.5 to 100.0)
    100.0 (73.5 to 100.0)
    0.0 (0.0 to 33.6)
    100.0 (73.5 to 100.0)
    100.0 (71.5 to 100.0)
    100.0 (71.5 to 100.0)
    0.0 (0.0 to 36.9)
    0.0 (0.0 to 41.0)
        S1-binding IgG level assay:6months after dose2
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    100.0 (69.2 to 100.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    100.0 (71.5 to 100.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
        RBD-binding IgG level assay:7days after dose1
    0.0 (0.0 to 26.5)
    0 (-99999 to 99999)
    0.0 (0.0 to 26.5)
    8.3 (0.2 to 38.5)
    0.0 (0.0 to 70.8)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0.0 (0.0 to 33.6)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0.0 (0.0 to 33.6)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
    0 (0 to 0)
        RBD-binding IgG level assay:21days after dose1
    100.0 (73.5 to 100.0)
    91.7 (61.5 to 99.8)
    100.0 (73.5 to 100.0)
    100.0 (73.5 to 100.0)
    0.0 (0.0 to 70.8)
    100.0 (71.5 to 100.0)
    100.0 (73.5 to 100.0)
    100.0 (73.5 to 100.0)
    0.0 (0.0 to 33.6)
    72.7 (39.0 to 94.0)
    100.0 (73.5 to 100.0)
    100.0 (73.5 to 100.0)
    0.0 (0.0 to 33.6)
    91.7 (61.5 to 99.8)
    83.3 (51.6 to 97.9)
    100.0 (71.5 to 100.0)
    11.1 (0.3 to 48.2)
    0.0 (0.0 to 41.0)
        RBD-binding IgG level assay:7days after dose2
    100.0 (73.5 to 100.0)
    91.7 (61.5 to 99.8)
    100.0 (73.5 to 100.0)
    0 (0 to 0)
    0 (0 to 0)
    100.0 (71.5 to 100.0)
    100.0 (73.5 to 100.0)
    100.0 (71.5 to 100.0)
    0.0 (0.0 to 33.6)
    100.0 (71.5 to 100.0)
    100.0 (73.5 to 100.0)
    100.0 (73.5 to 100.0)
    0.0 (0.0 to 33.6)
    100.0 (73.5 to 100.0)
    100.0 (71.5 to 100.0)
    100.0 (71.5 to 100.0)
    11.1 (0.3 to 48.2)
    0.0 (0.0 to 41.0)
        RBD-binding IgG level assay:14days after dose2
    100.0 (73.5 to 100.0)
    100.0 (73.5 to 100.0)
    100.0 (73.5 to 100.0)
    0 (0 to 0)
    0 (0 to 0)
    100.0 (71.5 to 100.0)
    100.0 (73.5 to 100.0)
    100.0 (66.4 to 100.0)
    0.0 (0.0 to 33.6)
    100.0 (71.5 to 100.0)
    100.0 (73.5 to 100.0)
    100.0 (73.5 to 100.0)
    0.0 (0.0 to 33.6)
    100.0 (71.5 to 100.0)
    100.0 (71.5 to 100.0)
    100.0 (71.5 to 100.0)
    11.1 (0.3 to 48.2)
    0.0 (0.0 to 41.0)
        RBD-binding IgG level assay:1month after dose2
    100.0 (73.5 to 100.0)
    100.0 (73.5 to 100.0)
    100.0 (73.5 to 100.0)
    0 (0 to 0)
    0 (0 to 0)
    100.0 (71.5 to 100.0)
    100.0 (71.5 to 100.0)
    100.0 (71.5 to 100.0)
    0.0 (0.0 to 33.6)
    100.0 (71.5 to 100.0)
    100.0 (73.5 to 100.0)
    100.0 (73.5 to 100.0)
    0.0 (0.0 to 33.6)
    100.0 (73.5 to 100.0)
    100.0 (71.5 to 100.0)
    100.0 (71.5 to 100.0)
    12.5 (0.3 to 52.7)
    0.0 (0.0 to 41.0)
        RBD-binding IgG level assay:6months after dose2
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    No statistical analyses for this end point

    Secondary: GMR Based on GMT NT50 - Comparison of Subjects 12 to 15 Years of Age to Subjects 16 to 25 Years of Age (Immunogenicity Subset) - Subjects Without Evidence of Infection up to 1 Month After Dose 2 - Dose 2 Evaluable Immunogenicity Population: Phase2/3

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    End point title
    		 GMR Based on GMT NT50 - Comparison of Subjects 12 to 15 Years of Age to Subjects 16 to 25 Years of Age (Immunogenicity Subset) - Subjects Without Evidence of Infection up to 1 Month After Dose 2 - Dose 2 Evaluable Immunogenicity Population: Phase2/3
    End point description
    GMR based on GMT NT50 - comparison of subjects 12 through 15 years of age to subjects 16 through 25 years of age: subjects without evidence of infection up to 1 month after dose 2 were reported in this endpoint.
    End point type
    Secondary
    End point timeframe
    1 Month After Dose 2
    End point values
    		 BNT162b2 (30 mcg): 12-15 years of age BNT162b2 (30 mcg): 16-25 years of age
    Number of subjects analysed
    190
    170
    Units: Ratio
        geometric mean (confidence interval 95%)
    1239.5 (1095.5 to 1402.5)
    705.1 (621.4 to 800.2)
    Statistical analysis title
    		 BNT162b2 30mcg 12-15 years vs 16-25 years of age
    Comparison groups
    BNT162b2 (30 mcg): 12-15 years of age v BNT162b2 (30 mcg): 16-25 years of age
    Number of subjects included in analysis
    360
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Geometric mean ratio
    Point estimate
    1.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.47
         upper limit
    		 2.1

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment emergent adverse events are reported from time of first dose of study treatment up to 9999 days after last dose of study treatment .
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    PC Fup Period - Ph1 - BNT162b1 10 mcg
    Reporting group description
    		 Blinded Placebo-Controlled Follow-up Period - Phase 1 / BNT162b1 10 mcg

    Reporting group title
    PC Fup Period - Ph1 - BNT162b1 20 mcg
    Reporting group description
    		 Blinded Placebo-Controlled Follow-up Period - Phase 1 / BNT162b1 20 mcg

    Reporting group title
    PC Fup Period - Ph3 Sub 12-15 YOA - BNT162b2 (30 mcg)
    Reporting group description
    		 Blinded Placebo-Controlled Follow-up Period - Phase 3 - Subjects 12 Through 15 Years of Age / BNT162b2 (30 mcg)

    Reporting group title
    PC Fup Period - Ph3 Sub 12-15 YOA - Placebo
    Reporting group description
    		 Blinded Placebo-Controlled Follow-up Period - Phase 3 - Subjects 12 Through 15 Years of Age / Placebo

    Reporting group title
    OL Fup Period - Ph2/3 Sub >=16 YOA (Final) - Pla/B2 (30 mcg)
    Reporting group description
    		 Open Label Crossover Follow-up Period - Phase 2/3 Subjects >=16 Years of Age (Final) / Original Placebo/BNT162b2 (30 mcg)

    Reporting group title
    PC Fup Period - Ph2/3 Sub >=16 YOA (Final) - BNT162b2 (30 mcg)
    Reporting group description
    		 Blinded Placebo-Controlled Follow-up Period - Phase 2/3 Subjects >=16 Years of Age (Final) / BNT162b2 (30 mcg)

    Reporting group title
    PC Fup Period - Ph2/3 Sub >=16 YOA (Final) - Placeb
    Reporting group description
    		 Blinded Placebo-Controlled Follow-up Period - Phase 2/3 Subjects >=16 Years of Age (Final) / Placebo

    Reporting group title
    PC Fup Period - Ph1 - Placebo
    Reporting group description
    		 Blinded Placebo-Controlled Follow-up Period - Phase 1 / Placebo

    Reporting group title
    OL Fup Period - Ph1 - Placebo/BNT162b2 30 mcg
    Reporting group description
    		 Open Label Follow-up Period - Phase 1 (Crossover BNT Group for Subjects Who Originally Received Placebo ) / Original Placebo/BNT162b2 30 mcg

    Reporting group title
    PC Fup Period - Ph1 - BNT162b2 30 mcg
    Reporting group description
    		 Blinded Placebo-Controlled Follow-up Period - Phase 1 / BNT162b2 30 mcg

    Reporting group title
    PC Fup Period - Ph1 - BNT162b2 20 mcg
    Reporting group description
    		 Blinded Placebo-Controlled Follow-up Period - Phase 1 / BNT162b2 20 mcg

    Reporting group title
    PC Fup Period - Ph1 - BNT162b2 10 mcg
    Reporting group description
    		 Blinded Placebo-Controlled Follow-up Period - Phase 1 / BNT162b2 10 mcg

    Reporting group title
    PC Fup Period - Ph1 - BNT162b1 100 mcg
    Reporting group description
    		 Blinded Placebo-Controlled Follow-up Period - Phase 1 / BNT162b1 100 mcg

    Reporting group title
    PC Fup Period - Ph1 - BNT162b1 30 mcg
    Reporting group description
    		 Blinded Placebo-Controlled Follow-up Period - Phase 1 / BNT162b1 30 mcg

    Reporting group title
    OL Fup Period - Ph3 Sub 12-15 YOA - Placebo/BNT162b2 (30 mcg)
    Reporting group description
    		 Open Label Crossover Follow-up Period - Phase 3 - Subjects 12 Through 15 Years of Age / Original Placebo/BNT162b2 (30 mcg)

    Reporting group title
    PC Fup Period - Ph2 - BNT162b2 (30 mcg)
    Reporting group description
    		 Blinded Placebo-Controlled Follow-up Period - Phase 2 / BNT162b2 (30 mcg)

    Reporting group title
    Sub Rerand to Receive 1 Booster Dose - BNT162b2 (10 mcg)
    Reporting group description
    		 G4 LD - BNT162b2-Experienced Subjects Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose) / BNT162b2 (10 mcg)

    Reporting group title
    Sub Rerand to Receive 1 Booster Dose - BNT162b2 (5 mcg)
    Reporting group description
    		 G4 LD - BNT162b2-Experienced Subjects Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose) / BNT162b2 (5 mcg)

    Reporting group title
    BNT162b2-Naive Subjects / BNT162b2SA (30 mcg)
    Reporting group description
    		 BNT162b2-Naive Subjects / BNT162b2SA (30 mcg)

    Reporting group title
    Sub Rerand to Receive 1 Booster Dose - BNT162b2SA (30 mcg)
    Reporting group description
    		 Booster G12 - BNT162b2-Experienced Subjects Who Were Rerandomized to Receive 1 Booster Dose (30 mcg) / BNT162b2SA (30 mcg)

    Reporting group title
    PC Fup Period - Ph2 - Placebo
    Reporting group description
    		 Blinded Placebo-Controlled Follow-up Period - Phase 2 / Placebo

    Reporting group title
    Sub Assigned to 2 Booster Doses - BNT162b2SA (30 mcg, 2 doses)
    Reporting group description
    		 Booster G0 - BNT162b2-Experienced Subjects Who Were Assigned to Receive 2 Booster Doses (30 mcg) / BNT162b2SA (30 mcg, 2 doses)

    Reporting group title
    Naive Sub Received Booster Dose (PA 18) - BNT162b2 (30 mcg)
    Reporting group description
    		 BNT162b2-Naive Subjects - Subjects Who Received Booster Dose of BNT162b2 (30 mcg) as Part of Protocol Amendment 18 / BNT162b2 (30 mcg)

    Reporting group title
    Add Booster for Low Dose Booster Sub - BNT162b2 (30 mcg)
    Reporting group description
    		 Additional Booster LD - BNT162b2-Experienced Subjects Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose) / BNT162b2 (30 mcg)

    Reporting group title
    Add Booster for 2 Booster Doses Sub - BNT162b2 (30 mcg)
    Reporting group description
    		 Additional Booster G0 - BNT162b2-Experienced Subjects Who Were Assigned to Receive 2 Booster Doses (30 mcg) / BNT162b2 (30 mcg)

    Reporting group title
    Add Booster for 1 Booster Dose Sub - BNT162b2 (30 mcg)
    Reporting group description
    		 Additional Booster G12 - BNT162b2-Experienced Subjects Who Were Rerandomized to Receive 1 Booster Dose (30 mcg) / BNT162b2 (30 mcg)

    Reporting group title
    Ph2/3 - Subjects Who are Part of PA 18 - BNT162b2 (30 mcg)
    Reporting group description
    		 Phase 2/3 - Subjects Who Received Booster Dose of BNT162b2 (30 mcg) as Part of Protocol Amendment 18 / BNT162b2 (30 mcg)

    Reporting group title
    Sub Rerand to 1 Booster Dose - BNT162b2 (30 mcg)
    Reporting group description
    		 Booster G12 - BNT162b2-Experienced Subjects Who Were Rerandomized to Receive 1 Booster Dose (30 mcg) / BNT162b2 (30 mcg)

    Serious adverse events
    		 PC Fup Period - Ph1 - BNT162b1 10 mcg PC Fup Period - Ph1 - BNT162b1 20 mcg PC Fup Period - Ph3 Sub 12-15 YOA - BNT162b2 (30 mcg) PC Fup Period - Ph3 Sub 12-15 YOA - Placebo OL Fup Period - Ph2/3 Sub >=16 YOA (Final) - Pla/B2 (30 mcg) PC Fup Period - Ph2/3 Sub >=16 YOA (Final) - BNT162b2 (30 mcg) PC Fup Period - Ph2/3 Sub >=16 YOA (Final) - Placeb PC Fup Period - Ph1 - Placebo OL Fup Period - Ph1 - Placebo/BNT162b2 30 mcg PC Fup Period - Ph1 - BNT162b2 30 mcg PC Fup Period - Ph1 - BNT162b2 20 mcg PC Fup Period - Ph1 - BNT162b2 10 mcg PC Fup Period - Ph1 - BNT162b1 100 mcg PC Fup Period - Ph1 - BNT162b1 30 mcg OL Fup Period - Ph3 Sub 12-15 YOA - Placebo/BNT162b2 (30 mcg) PC Fup Period - Ph2 - BNT162b2 (30 mcg) Sub Rerand to Receive 1 Booster Dose - BNT162b2 (10 mcg) Sub Rerand to Receive 1 Booster Dose - BNT162b2 (5 mcg) BNT162b2-Naive Subjects / BNT162b2SA (30 mcg) Sub Rerand to Receive 1 Booster Dose - BNT162b2SA (30 mcg) PC Fup Period - Ph2 - Placebo Sub Assigned to 2 Booster Doses - BNT162b2SA (30 mcg, 2 doses) Naive Sub Received Booster Dose (PA 18) - BNT162b2 (30 mcg) Add Booster for Low Dose Booster Sub - BNT162b2 (30 mcg) Add Booster for 2 Booster Doses Sub - BNT162b2 (30 mcg) Add Booster for 1 Booster Dose Sub - BNT162b2 (30 mcg) Ph2/3 - Subjects Who are Part of PA 18 - BNT162b2 (30 mcg) Sub Rerand to 1 Booster Dose - BNT162b2 (30 mcg)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    13 / 1131 (1.15%)
    2 / 1129 (0.18%)
    353 / 20267 (1.74%)
    428 / 21910 (1.95%)
    291 / 21911 (1.33%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    1 / 24 (4.17%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    13 / 1014 (1.28%)
    1 / 180 (0.56%)
    0 / 76 (0.00%)
    1 / 79 (1.27%)
    4 / 324 (1.23%)
    2 / 315 (0.63%)
    0 / 180 (0.00%)
    1 / 30 (3.33%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    1 / 378 (0.26%)
    67 / 23295 (0.29%)
    2 / 306 (0.65%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma gastric
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    1 / 180 (0.56%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    3 / 21910 (0.01%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma pancreas
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    3 / 21910 (0.01%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adrenal gland cancer
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adrenal neoplasm
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal cancer
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angiosarcoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    B-cell lymphoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    2 / 21910 (0.01%)
    2 / 21911 (0.01%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign hydatidiform mole
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biliary cancer metastatic
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    1 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer recurrent
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Borderline serous tumour of ovary
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain neoplasm
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    3 / 20267 (0.01%)
    6 / 21910 (0.03%)
    4 / 21911 (0.02%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 6
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer in situ
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer metastatic
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    2 / 20267 (0.01%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer stage I
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    1 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic myeloid leukaemia
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clear cell renal cell carcinoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colorectal adenoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cutaneous T-cell lymphoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ductal adenocarcinoma of pancreas
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endometrial adenocarcinoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    2 / 20267 (0.01%)
    1 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endometrial cancer
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Follicular lymphoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gallbladder cancer stage II
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal stromal tumour
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hormone receptor positive breast cancer
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypergammaglobulinaemia benign monoclonal
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intraductal proliferative breast lesion
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    2 / 20267 (0.01%)
    1 / 21910 (0.00%)
    2 / 21911 (0.01%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive breast carcinoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    5 / 20267 (0.02%)
    2 / 21910 (0.01%)
    2 / 21911 (0.01%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 5
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive lobular breast carcinoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    2 / 20267 (0.01%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngeal papilloma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leydig cell tumour of the testis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lobular breast carcinoma in situ
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    1 / 21910 (0.00%)
    2 / 21911 (0.01%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    2 / 20267 (0.01%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphocytic leukaemia
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    2 / 20267 (0.01%)
    1 / 21910 (0.00%)
    5 / 21911 (0.02%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 5
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mantle cell lymphoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    1 / 324 (0.31%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mesothelioma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to liver
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to lung
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to lymph nodes
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    2 / 21911 (0.01%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastatic gastric cancer
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastatic malignant melanoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastatic squamous cell carcinoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mucoepidermoid carcinoma of salivary gland
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuroendocrine carcinoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuroendocrine tumour
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma recurrent
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-small cell lung cancer stage III
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-small cell lung cancer stage IV
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oropharyngeal cancer recurrent
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oropharyngeal squamous cell carcinoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian adenoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    1 / 306 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cancer stage I
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    2 / 21911 (0.01%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma metastatic
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    2 / 21910 (0.01%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic neuroendocrine tumour
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Papillary serous endometrial carcinoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    2 / 21911 (0.01%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parathyroid tumour benign
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pituitary tumour benign
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    9 / 20267 (0.04%)
    3 / 21910 (0.01%)
    2 / 21911 (0.01%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 9
    0 / 3
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polycythaemia vera
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer stage II
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer metastatic
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhabdomyosarcoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin cancer
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of head and neck
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of the cervix
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Teratoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Testis cancer
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsil cancer
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thyroid cancer
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    2 / 21910 (0.01%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transitional cell carcinoma recurrent
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine cancer
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    2 / 20267 (0.01%)
    1 / 21910 (0.00%)
    4 / 21911 (0.02%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular neoplasm
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine leiomyosarcoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Accelerated hypertension
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic aneurysm
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    2 / 21910 (0.01%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aneurysm
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    2 / 21911 (0.01%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic dissection
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    3 / 21910 (0.01%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    4 / 20267 (0.02%)
    4 / 21910 (0.02%)
    4 / 21911 (0.02%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    1 / 315 (0.32%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    0 / 4
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    2 / 20267 (0.01%)
    3 / 21910 (0.01%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive urgency
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    2 / 21910 (0.01%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iliac artery dissection
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    2 / 21911 (0.01%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Superficial vein thrombosis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Finger amputation
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion incomplete
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abortion spontaneous
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    8 / 20267 (0.04%)
    6 / 21910 (0.03%)
    3 / 21911 (0.01%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 8
    0 / 6
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abortion spontaneous incomplete
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ectopic pregnancy
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gestational hypertension
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retained products of conception
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    2 / 20267 (0.01%)
    5 / 21910 (0.02%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 5
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    1 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug withdrawal syndrome
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    2 / 20267 (0.01%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Electrocution
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypothermia
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Impaired healing
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza like illness
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    3 / 20267 (0.01%)
    4 / 21910 (0.02%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Shoulder injury related to vaccine administration
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Treatment noncompliance
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular stent occlusion
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaphylactoid reaction
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaphylactic shock
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Miscarriage of partner
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    2 / 21910 (0.01%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy of partner
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Abnormal uterine bleeding
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenomyosis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adnexal torsion
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    2 / 21911 (0.01%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endometrial thickening
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast hyperplasia
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Heavy menstrual bleeding
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endometriosis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    2 / 21910 (0.01%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian mass
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectocele
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vaginal prolapse
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    2 / 20267 (0.01%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    5 / 20267 (0.02%)
    2 / 21910 (0.01%)
    2 / 21911 (0.01%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 5
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    2 / 21910 (0.01%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthmatic crisis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    4 / 21910 (0.02%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 5
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diaphragmatic paralysis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    1 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nasal septum deviation
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    3 / 20267 (0.01%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    2 / 20267 (0.01%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    11 / 20267 (0.05%)
    5 / 21910 (0.02%)
    7 / 21911 (0.03%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 11
    0 / 5
    0 / 7
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary sarcoidosis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory arrest
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Acute psychosis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Affective disorder
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcohol abuse
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcohol withdrawal syndrome
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    2 / 20267 (0.01%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcoholism
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anorexia nervosa
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    1 / 1014 (0.10%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 1131 (0.09%)
    0 / 1129 (0.00%)
    2 / 20267 (0.01%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bipolar I disorder
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bipolar disorder
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    2 / 20267 (0.01%)
    1 / 21910 (0.00%)
    2 / 21911 (0.01%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    2 / 20267 (0.01%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Conversion disorder
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 1131 (0.09%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    3 / 1131 (0.27%)
    0 / 1129 (0.00%)
    3 / 20267 (0.01%)
    4 / 21910 (0.02%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
    0 / 0
    0 / 3
    0 / 4
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression suicidal
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Disorientation
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug abuse
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug dependence
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hallucination
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    2 / 20267 (0.01%)
    0 / 21910 (0.00%)
    2 / 21911 (0.01%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    1 / 1014 (0.10%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental disorder
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obsessive-compulsive disorder
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Panic attack
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post-traumatic stress disorder
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    1 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    1 / 1014 (0.10%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal behaviour
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    4 / 1131 (0.35%)
    0 / 1129 (0.00%)
    5 / 20267 (0.02%)
    0 / 21910 (0.00%)
    2 / 21911 (0.01%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    1 / 1014 (0.10%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
    0 / 0
    0 / 6
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 1131 (0.09%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    1 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    1 / 1014 (0.10%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Alcoholic liver disease
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute hepatic failure
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bile duct stone
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    2 / 21910 (0.01%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Autoimmune hepatitis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biliary colic
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    2 / 21910 (0.01%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biliary dyskinesia
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biliary obstruction
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    7 / 21910 (0.03%)
    3 / 21911 (0.01%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    2 / 23295 (0.01%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 7
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    2 / 20267 (0.01%)
    2 / 21910 (0.01%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    6 / 20267 (0.03%)
    6 / 21910 (0.03%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 6
    0 / 6
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis obstructive
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis acute
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatocellular injury
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperbilirubinaemia neonatal
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Portal vein thrombosis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Portosplenomesenteric venous thrombosis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood glucose abnormal
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood lactic acid
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood pressure increased
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Red blood cell morphology abnormal
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcohol poisoning
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anastomotic complication
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anastomotic stenosis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Animal bite
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    3 / 20267 (0.01%)
    3 / 21910 (0.01%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arterial injury
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthropod bite
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain contusion
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Burns second degree
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Burns third degree
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    2 / 23295 (0.01%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon injury
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    1 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Delayed recovery from anaesthesia
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Exposure during pregnancy
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    2 / 20267 (0.01%)
    2 / 21910 (0.01%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    2 / 20267 (0.01%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 1131 (0.09%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Flail chest
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    1 / 21910 (0.00%)
    2 / 21911 (0.01%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fractured sacrum
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    1 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    2 / 21911 (0.01%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    1 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    2 / 21911 (0.01%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle contusion
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle rupture
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neck injury
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Open fracture
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    2 / 20267 (0.01%)
    3 / 21910 (0.01%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    1 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    2 / 20267 (0.01%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural complication
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post-traumatic pain
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative ileus
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural dizziness
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural haemorrhage
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    1 / 1014 (0.10%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    4 / 21910 (0.02%)
    3 / 21911 (0.01%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    2 / 23295 (0.01%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 4
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    4 / 20267 (0.02%)
    2 / 21910 (0.01%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Scapula fracture
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal column injury
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal cord injury cervical
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Splenic rupture
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    2 / 20267 (0.01%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic haemothorax
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic intracranial haemorrhage
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic liver injury
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    1 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic renal injury
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    1 / 1014 (0.10%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    1 / 1014 (0.10%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    2 / 21910 (0.01%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    1 / 1014 (0.10%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    2 / 21910 (0.01%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    BRCA1 gene mutation
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    1 / 20267 (0.00%)
    0 / 21910 (0.00%)
    0 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital bladder neck obstruction
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 1131 (0.00%)
    0 / 1129 (0.00%)
    0 / 20267 (0.00%)
    0 / 21910 (0.00%)
    1 / 21911 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 24 (0.00%)
    0 / 1014 (0.00%)
    0 / 180 (0.00%)
    0 / 76 (0.00%)
    0 / 79 (0.00%)
    0 / 324 (0.00%)
    0 / 315 (0.00%)
    0 / 180 (0.00%)
    0 / 30 (0.00%)
    0 / 236 (0.00%)
    0 / 71 (0.00%)
    0 / 15 (0.00%)
    0 / 378 (0.00%)
    0 / 23295 (0.00%)
    0 / 306 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0