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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	v2(current)
This version publication date	28 Sep 2023
First version publication date	26 Aug 2023
Other versions	v1
Version creation reason

Trial information 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

Trial information Top of page

Subject disposition Top of page
Recruitment
Recruitment details	The study consisted of 2 parts, Phase 1 and Phase 2/3. The overall period presented below was created to support display of the demographic characteristics for all study phases. The complete disposition information is presented below in separate tables for each individual phase, respectively.
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:18-55 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: 18-85 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 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
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: 18-55 years of age
Arm description	Subjects aged 18-55 years were assigned to receive 2 doses of 30 microgram BNT162b2 SA 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 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:18-55 years of age 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: 18-85 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: 18-55 years of age 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 (1 dose)
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 (1 dose) 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 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 aged 12-15 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)
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 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 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 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 microgram/0.5 milliliter
Arm title	Phase2/3: Placebo 12-15 years of age
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 of age Phase2/3: Placebo 12-15 years of age 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: 18-55 years of age
Arm description	Subjects aged 18-55 years were assigned to receive 2 doses of 30 microgram BNT162b2 SA 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 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: 18-55 years of age Started 333 Completed 228 Not completed 105      Consent withdrawn by subject 19      Adverse event, non-fatal 1      No longer meets eligibility criteria 8      Unspecified 24      Lost to follow-up 50      Protocol deviation 3

Subject disposition Top of page

Baseline characteristics Top of page
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:18-55 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: 18-85 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 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 (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: 18-55 years of age
Reporting group description	Subjects aged 18-55 years were assigned to receive 2 doses of 30 microgram BNT162b2 SA vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
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:18-55 years of age 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: 18-85 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: 18-55 years of age 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

Baseline characteristics Top of page

End points Top of page
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:18-55 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: 18-85 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 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 (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: 18-55 years of age
Reporting group description	Subjects aged 18-55 years were assigned to receive 2 doses of 30 microgram BNT162b2 SA vaccine (250 microgram/0.5 milliliter) intramuscularly separated by 21 days interval as part of this study.
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 (1 dose)
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 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 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 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	Phase2/3: 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 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: 18-55 years of age
Reporting group description	Subjects aged 18-55 years were assigned to receive 2 doses of 30 microgram BNT162b2 SA 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: 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 2 doses of 100 microgram BNT162b1 vaccine 250 microgram/0.5 milliliter intramuscularly and received only 1 dose due to reactogenicity.
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 randomised to receive 0.9% sodium chloride solution for injection intramuscularly.
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 BNT162b2 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 2 doses of 20 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 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 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): >=16 years of age
Subject analysis set type	Per protocol
Subject analysis set 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.
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: 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 randomised to receive 0.9% sodium chloride solution for injection intramuscularly.
Subject analysis set title	BNT162b2 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 BNT162b2 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 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 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 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 BNT162b2 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 2 doses of 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 2 doses of 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 2 doses of 30 microgram BNT162b1 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	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 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 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 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): 56-85 years of age
Subject analysis set type	Per protocol
Subject analysis set description	Subjects aged 56-85 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.
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: 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 of age
Subject analysis set type	Per protocol
Subject analysis set description	Subjects aged 56-85 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.
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 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: 18-85 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 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	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 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): 56-85 Years
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: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 BNT162b2 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 of age
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	BNT162b2-experienced subjects originally randomised to receive 2 doses of 30 microgram BNT162b2SA vaccine (250 microgram/0.5 milliliter) and assigned to receive 2 booster doses of 30 microgram BNT162b2 (250 microgram/0.5 milliliter).
Subject analysis set title	BNT162b2 (30 mcg)
Subject analysis set type	Per protocol
Subject analysis set description	BNT162b2-experienced subjects re-randomised to receive 1 dose of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter) and had e-diary data after Dose 1.
Subject analysis set title	BNT162b2SA (30 mcg)
Subject analysis set type	Per protocol
Subject analysis set description	BNT162b2-experienced subjects re-randomised to receive 1 dose of 30 microgram BNT162b2SA vaccine (250 microgram/0.5 milliliter) and had e-diary data after Dose 1.
Subject analysis set title	BNT162b2SA (30 mcg), 2 doses
Subject analysis set type	Per protocol
Subject analysis set description	BNT162b2-experienced subjects who were assigned to receive 2 booster doses of 30 microgram BNT162b2SA vaccine (250 microgram/0.5 milliliter) intramuscularly.
Subject analysis set title	BNT162b2SA (30 mcg)
Subject analysis set type	Per protocol
Subject analysis set description	BNT162b2-experienced subjects who were assigned to receive 2 booster doses of 30 microgram BNT162b2SA vaccine (250 microgram/0.5 milliliter) intramuscularly and had e-diary data after Dose 2.
Subject analysis set title	BNT162b2SA (30 mcg)
Subject analysis set type	Per protocol
Subject analysis set description	BNT162b2-naive subjects enrolled to receive 2 dose of 30 microgram BNT162b2SA vaccine (250 microgram/0.5 milliliter) and had ediary data after Dose 1.
Subject analysis set title	BNT162b2SA (30 mcg)
Subject analysis set type	Per protocol
Subject analysis set description	BNT162b2-naive subjects enrolled to receive 2 dose of 30 microgram BNT162b2SA vaccine (250 microgram/0.5 milliliter) and had e-diary data after Dose 2.
Subject analysis set title	BNT162b2 (30 mcg)
Subject analysis set type	Per protocol
Subject analysis set description	BNT162b2-experienced subjects re-randomised to receive 1 dose of 30 microgram BNT162b2 vaccine (250 microgram/0.5 milliliter).
Subject analysis set title	BNT162b2SA (30 mcg)
Subject analysis set type	Per protocol
Subject analysis set description	BNT162b2-experienced subjects re-randomised to receive 1 dose of 30 microgram BNT162b2SA vaccine (250 microgram/0.5 milliliter).
Subject analysis set title	BNT162b2SA (30 mcg)
Subject analysis set type	Per protocol
Subject analysis set description	BNT162b2-naive subjects enrolled to receive 2 dose of 30 microgram BNT162b2SA vaccine (250 microgram/0.5 milliliter).
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	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 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): 1 Month After Booster Dose
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 and then re-randomised to receive a booster dose of BNT162b2.
Subject analysis set title	BNT162b2SA (30 mcg):1 Month After Booster Dose
Subject analysis set type	Per protocol
Subject analysis set description	Subjects were randomised to receive 2 doses of 30 microgram BNT162b2SA vaccine 250 microgram/0.5 milliliter intramuscularly and then re-randomised to receive a booster dose of BNT162b2.
Subject analysis set title	BNT162b2 (30 mcg): 1 Month After Dose 2
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 and then re-randomised to receive a booster dose of BNT162b2.
Subject analysis set title	BNT162b2SA 30 mcg: 1 Month After Dose 2
Subject analysis set type	Per protocol
Subject analysis set description	Subjects were randomised to receive 2 doses of 30 microgram BNT162b2SA vaccine 250 microgram/0.5 milliliter intramuscularly and then re-randomised to receive a booster dose of BNT162b2.
Subject analysis set title	BNT162b2 (30 mcg): 1 Month After Booster Dose
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 and then re-randomised to receive a booster dose of BNT162b2.
Subject analysis set title	BNT162b2SA (30 mcg): 1 Month After Booster Dose
Subject analysis set type	Per protocol
Subject analysis set description	Subjects were randomised to receive 2 doses of 30 microgram BNT162b2SA vaccine 250 microgram/0.5 milliliter intramuscularly and then re-randomised to receive a booster dose of BNT162b2.
Subject analysis set title	BNT162b2 (30 mcg): 1 Month After Dose 2
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 and then re-randomised to receive a booster dose of BNT162b2.
Subject analysis set title	BNT162b2SA 30 mcg: 1 Month After Dose 2
Subject analysis set type	Per protocol
Subject analysis set description	Subjects were randomised to receive 2 doses of 30 microgram BNT162b2SA vaccine 250 microgram/0.5 milliliter intramusculary and then rerandomised to receive a booster dose of BNT162b2.
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 BNT162b2SA 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 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 BNT162b2SA 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): 1 Month After Second Booster Dose
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 BNT162b2SA 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	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 (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: 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 received 2 doses of placebo followed by 2 doses of BNT162b2.
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.
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 (30 mcg): 1 Month After Dose 2
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 5 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 BNT162b2 5 mcg (250mcg/0.5ml) intramuscularly.
Subject analysis set title	BNT162b2 5 mcg: >55 years of age
Subject analysis set type	Per protocol
Subject analysis set description	Subjects aged >55 years were randomised to receive BNT162b2 5 mcg (250mcg/0.5ml) intramuscularly.
Subject analysis set title	BNT162b2 10 mcg: 18-55 years of age
Subject analysis set type	Per protocol
Subject analysis set description	Subjects aged 18-55 years were randomised to receive BNT162b2 5 mcg (250mcg/0.5ml) intramuscularly.
Subject analysis set title	BNT162b2 10 mcg: >55 years of age
Subject analysis set type	Per protocol
Subject analysis set description	Subjects aged >55 years were randomised to receive BNT162b2 5 mcg (250mcg/0.5ml) intramuscularly.

End points Top of page

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Dose 1: Phase 1 Top of page
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.
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 was planned 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%)     Redness: Mild 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) 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) 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 Local Reactions Within 7 Days After Dose 1: Phase 1 Top of page

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Dose 2: Phase 1 Top of page
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 .
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 was planned 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) 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: Moderate 0 (0.0 to 26.5) 0 (0.0 to 26.5) 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 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)     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) 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) 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) 0 (0.0 to 26.5) 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 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) 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 75 (42.8 to 94.5) 50.0 (21.1 to 78.9) 66.7 (34.9 to 90.1) 50.0 (21.1 to 78.9) 58.3 (27.7 to 84.8) 75.0 (42.8 to 94.5) 22.2 (2.8 to 60.0) 50.0 (21.1 to 78.9) 66.7 (34.9 to 90.1) 58.3 (27.7 to 84.8) 0 (0.0 to 33.6) 25.0 (5.5 to 57.2) 58.3 (27.7 to 84.8) 50.0 (34.9 to 90.1) 11.1 (0.3 to 48.2) 22.2 (2.8 to 60.0)     Pain at injection site: Moderate 8.3 (0.2 to 38.5) 25.0 (5.5 to 57.2) 33.3 (9.9 to 65.1) 8.3 (0.2 to 38.5) 25.0 (5.5 to 27.2) 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) 0 (0.0 to 26.5) 16.7 (2.1 to 48.4) 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) 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: 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 Local Reactions Within 7 Days After Dose 2: Phase 1 Top of page

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Dose 1: Phase 1 Top of page
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 or parents/legal guardians of subjects using e-diary. Fever=temperature >=38.0 deg C categorised as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg 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 (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalisation for hypotensive shock). Diarrhea:mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (≥6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalisation). Number analyzed = Safety population with e-diary data after Dose 1.
End point type	Primary
End point timeframe	Within 7 Days After Dose 1
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 was planned 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 1: Phase 1 Top of page

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Dose 2: Phase 1 Top of page
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 or parents/legal guardians of subjects using e-diary. Fever=temperature >=38.0 deg C categorised as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg 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 (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalisation for hypotensive shock). Diarrhea:mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (≥6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalisation). Number analyzed = Safety population with e-diary data after Dose 2.
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 was planned 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%)     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) 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) 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 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 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) 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) 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) 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 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) 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) 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) 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 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) 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) 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) 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 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 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 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 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 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) 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) 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 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 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) 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) 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) 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 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 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) 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) 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 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 2: Phase 1 Top of page

Primary: Percentage of Subjects Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: Phase 1 Top of page
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. 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 was planned 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 12 9 9 Units: Percentage of subjects     number (confidence interval 95%) 50.0 (21.1 to 78.9) 41.7 (15.2 to 72.3) 50.0 (21.1 to 78.9) 66.7 (34.9 to 90.1) 33.3 (0.8 to 90.6) 33.3 (9.9 to 65.1) 41.7 (15.2 to 72.3) 41.7 (15.2 to 72.3) 22.2 (2.8 to 60.0) 58.3 (27.7 to 84.8) 25.0 (5.5 to 57.2) 44.4 (13.7 to 78.8) 8.3 (0.2 to 38.5) 8.3 (0.2 to 38.5) 25.0 (5.5 to 57.2) 50.0 (21.1 to 78.9) 22.2 (2.8 to 60.0) 22.2 (2.8 to 60.0)
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 Top of page

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

Primary: Percentage of Subjects With Abnormalities in Hematology Parameters 1 Day After Dose 1: Phase 1 Top of page
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. Number of Subjects Analyzed signifies the subjects who had safety lab measurements 1 Day after Dose 1.
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 was planned 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 1 Day After Dose 1: Phase 1 Top of page

Primary: Percentage of Subjects With Abnormalities in Hematology Parameters 7 Days After Dose 1: Phase 1 Top of page
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. Number of Subjects Analyzed signifies the subjects who had safety lab measurements 7 days after Dose 1.
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 was planned 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 7 Days After Dose 1: Phase 1 Top of page

Primary: Percentage of Subjects With Abnormalities in Hematology Parameters Before Dose 2: Phase 1 Top of page
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. Number of Subjects Analyzed signifies the subjects who had safety lab measurements before Dose 2.
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 was planned 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 Before Dose 2: Phase 1 Top of page

Primary: Percentage of Subjects With Abnormalities in Hematology Parameters 7 Days After Dose 2: Phase 1 Top of page
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. Number of Subjects Analyzed signifies the subjects who had safety lab measurements 7 days after Dose 2.
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 was planned 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 (not applicable)     Neutrophils 8.3 0 8.3 0 0 0 0 0 8.3 0 0 8.3 0 0 0 0     Monocytes 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 8.3 0 0 0 0 0 0 0     Lymphocytes 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 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 2: Phase 1 Top of page

Primary: Percentage of Subjects With Abnormalities in Chemistry Parameters 1 Day After Dose 1: Phase 1 Top of page
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 reported for this endpoint are for bilirubin. Safety population include all randomised subjects who received at least 1 dose of the study intervention. Number of Subjects Analyzed signifies the subjects who had safety lab measurements 1 day after Dose 1.
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 was planned 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 1 Day After Dose 1: Phase 1 Top of page

Primary: Percentage of Subjects With Abnormalities in Chemistry Parameters 7 Days After Dose 1: Phase 1 Top of page
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. Number of Subjects Analyzed signifies the subjects who had safety lab measurements 7 days after Dose 1.
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 was planned 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 7 Days After Dose 1: Phase 1 Top of page

Primary: Percentage of Subjects With Abnormalities in Chemistry Parameters Before Dose 2: Phase 1 Top of page
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. Number of Subjects Analyzed signifies the subjects who had safety lab measurements before Dose 2.
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 was planned 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 Before Dose 2: Phase 1 Top of page

Primary: Percentage of Subjects With Abnormalities in Chemistry Parameters 7 Days After Dose 2: Phase 1 Top of page
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. Number of Subjects Analyzed signifies the subjects who had safety lab measurements 7 days after dose 2.
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 was planned 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 (not applicable) 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 7 Days After Dose 2: Phase 1 Top of page

Primary: Percentage of Subjects With Grade Shift in Hematology Parameters 1 Day After Dose 1: Phase 1 Top of page
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. Number of Subjects Analyzed signifies the subjects who had safety lab measurements at both baseline and 1 Day after Dose 1.
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 was planned 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 1 Day After Dose 1: Phase 1 Top of page

Primary: Percentage of Subjects With Grade Shift in Hematology Parameters 7 Days After Dose 1: Phase 1 Top of page
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. Number of Subjects Analyzed signifies the subjects who had safety lab measurements at baseline and 7 Days after Dose 1.
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 was planned 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 7 Days After Dose 1: Phase 1 Top of page

Primary: Percentage of Subjects With Grade Shift in Hematology Parameters Before Dose 2: Phase 1 Top of page
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. Number of Subjects Analyzed signifies the subjects who had safety lab measurements at baseline and before Dose 2.
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 was planned 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 Before Dose 2: Phase 1 Top of page

Primary: Percentage of Subjects With Grade Shift in Hematology Parameters 7 Days After Dose 2: Phase 1 Top of page
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. Number of Subjects Analyzed signifies the subjects who had safety lab measurements at baseline and 7 Days after Dose 2.
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 was planned 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 (not applicable)     Hemoglobin: Baseline Normal to Normal 58.3 66.7 91.7 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 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 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 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 8.3 0 0 0 0 0 0 0     Lymphocytes: Baseline Normal to Normal 91.7 83.3 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 11.1     Lymphocytes: Grade 1 to Normal 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 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 8.3 0 11.1     Neutrophil Decrease: Baseline Normal to Normal 75.0 83.3 83.3 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 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 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 8.3 0 0 0 8.3 0 0 0 0     Neutrophil Decrease: Grade 1 to Normal 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 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 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 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     Platelets Decrease: Grade 1 to Grade 1 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 8.3 0 0 11.1 0     Urea Nitrogen: Baseline Normal to Normal 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 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 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 11.1     Urea Nitrogen: Grade 1 to Grade 1 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 8.3 0 0 0 0 0 0 0 0     Urea Nitrogen: Normal to Grade 2 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 11.1 0 0 0 0 0     WBC Decrease: Baseline Normal to Normal 91.7 0 91.7 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 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 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 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 Hematology Parameters 7 Days After Dose 2: Phase 1 Top of page

Primary: Percentage of Subjects With Grade Shift in Chemistry Parameters 1 Day After Dose 1: Phase 1 Top of page
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. Number of Subjects Analyzed signifies the subjects who had safety lab measurements at baseline and 1 Day after Dose 1.
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 was planned 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 1 Day After Dose 1: Phase 1 Top of page

Primary: Percentage of Subjects With Grade Shift in Chemistry Parameters 7 Days After Dose 1: Phase 1 Top of page
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. Number of Subjects Analyzed signifies the subjects who had safety lab measurements at baseline and 7 days after Dose 1.
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 was planned 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 7 Days After Dose 1: Phase 1 Top of page

Primary: Percentage of Subjects With Grade Shift in Chemistry Parameters Before Dose 2: Phase 1 Top of page
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. Number of Subjects Analyzed signifies the subjects who had safety lab measurements at baseline and before Dose 2.
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 was planned 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 Before Dose 2: Phase 1 Top of page

Primary: Percentage of Subjects With Grade Shift in Chemistry Parameters 7 Days After Dose 2: Phase 1 Top of page
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. Number of Subjects Analyzed signifies the subjects who had safety lab measurements at baseline and 7 days after Dose 2.
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 was planned 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 (not applicable)     ALT Increased: Baseline Normal to Normal 0 91.7 91.7 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 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     ALT Increased: Grade 1 to Grade 1 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 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 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 8.3 11.1 0 0 0 0 0     AST Increased: Baseline Normal to Normal 0 90.9 91.7 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 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     AST Increased: Normal to Grade 1 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 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 8.3 0 0 0 0 0 0 0 0 0 0     Bilirubin: Grade 1 to Grade 1 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 11.1     Creatinine Increased: Baseline Normal to Normal 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 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 Top of page

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

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Dose 2: Phase 2/3 Top of page
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. Number of Subjects Analysed signifies the subjects 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 [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 was planned 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 Local Reactions Within 7 Days After Dose 2: Phase 2/3 Top of page

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Dose 1: Phase 2/3 Top of page
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 using e-diary.Fever=temperature >=38.0 deg C categorised as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg C. Fatigue, headache, chills, new/worsened muscle pain, new/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(>2 times in 24h), severe(requires IV hydration), Grade 4(emergency room visit/hospitalisation for hypotensive shock). Diarrhea:mild(2-3 loose stools in 24h),moderate(4-5 loose stools in 24h),severe (≥6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalisation).Number analyzed = Safety population with e-diary data after Dose 1. HIV positive subjects excluded.
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 was planned 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 1: Phase 2/3 Top of page

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Dose 2: Phase 2/3 Top of page
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 using e-diary.Fever=temperature >=38.0 deg C categorised as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg C. Fatigue, headache, chills, new/worsened muscle pain, new/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(>2 times in 24h), severe(requires IV hydration), Grade 4(emergency room visit/hospitalisation for hypotensive shock). Diarrhea:mild(2-3 loose stools in 24h),moderate(4-5 loose stools in 24h),severe (≥6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalisation).Number analyzed = Safety population with e-diary data after Dose 2. HIV positive subjects excluded.
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 was planned for this endpoint
End point values BNT162b2 (30 mcg): 56-85 Years BNT162b2 (30 mcg): 18-55 years of age 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 With Systemic Events Within 7 Days After Dose 2: Phase 2/3 Top of page

Primary: Percentage of Subjects Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: Phase 2/3 Top of page
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. Number of Subjects Analysed signifies the subjects in the safety population. HIV positive subjects were excluded from this analysis.
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 was planned 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 Adverse Events From Dose 1 to 1 Month After Dose 2: Phase 2/3 Top of page

Primary: Percentage of Subjects Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: Phase 2/3 Top of page
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. Number of Subjects Analysed signifies the subjects in the safety population. HIV positive subjects were excluded from this analysis.
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 was planned 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

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

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Dose 1: Phase 2 Top of page
End point title	Percentage of Subjects With Local Reactions Within 7 Days After Dose 1: Phase 2 [29]
End point description	Local reactions included redness, swelling and, pain at the injection site, recorded by subjects in an 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 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 percent (%) confidence interval (CI) 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=subjects in safety population, had e-diary data after Dose 1.
End point type	Primary
End point timeframe	Within 7 Days after Dose 1
Notes [29] - 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 was planned for this endpoint
End point values BNT162b2 (30 mcg): 18-55 years of age BNT162b2 (30 mcg): 56-85 years of age Placebo:18-55 years of age Placebo: 56 to 85 years of age Number of subjects analysed 88 92 90 90 Units: Percentage of subjects number (confidence interval 95%)     Redness: Mild 1.1 (0.0 to 6.2) 2.2 (0.3 to 7.6) 1.7 (0.3 to 4.8) 0.6 (0.0 to 3.1)     Redness: Moderate 2.3 (0.3 to 8.0) 2.2 (0.3 to 7.6) 2.2 (0.6 to 5.6) 0 (0.0 to 2.0)     Redness: Severe 0 (0.0 to 4.1) 0 (0.0 to 3.9) 0 (0.0 to 2.0) 0 (0.0 to 2.0)     Redness: Grade 4 0 (0.0 to 4.1) 0 (0.0 to 3.9) 0 (0.0 to 2.0) 0 (0.0 to 2.0)     Swelling: Mild 2.3 (0.3 to 8.0) 2.2 (0.3 to 7.6) 2.2 (0.6 to 5.6) 0 (0.0 to 2.0)     Swelling: Moderate 4.5 (1.3 to 11.2) 4.3 (1.2 to 10.8) 4.4 (1.9 to 8.6) 0 (0.0 to 2.0)     Swelling: Severe 0 (0.0 to 4.1) 0 (0.0 to 3.9) 0 (0.0 to 4.1) 0 (0.0 to 2.0)     Swelling: Grade 4 0 (0.0 to 4.1) 0 (0.0 to 3.9) 0 (0.0 to 4.1) 0 (0.0 to 2.0)     Pain at injection site: Mild 56.8 (45.8 to 67.3) 53.3 (42.6 to 63.7) 55.0 (47.4 to 62.4) 8.9 (5.2 to 14.0)     Pain at injection site: Moderate 28.4 (19.3 to 39.0) 16.3 (9.4 to 25.5) 22.2 (16.4 to 29.0) 0 (0.0 to 2.0)     Pain at injection site: Severe 0 (0.0 to 4.1) 1.1 (0.0 to 5.9) 0.6 (0.0 to 3.1) 0 (0.0 to 2.0)     Pain at injection site: Grade 4 0 (0.0 to 4.1) 0 (0.0 to 3.9) 0 (0.0 to 2.0) 0 (0.0 to 2.0)
No statistical analyses for this end point

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

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Dose 2: Phase 2 Top of page
End point title	Percentage of Subjects With Local Reactions Within 7 Days After Dose 2: Phase 2 [30]
End point description	Local reactions included redness, swelling and, pain at the injection site, recorded by 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 2.
End point type	Primary
End point timeframe	Within 7 Days after Dose 2
Notes [30] - 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 was planned for this endpoint
End point values BNT162b2 (30 mcg): 18-55 years of age BNT162b2 (30 mcg): 56-85 years of age Placebo:18-55 years of age Placebo: 56 to 85 years of age Number of subjects analysed 86 91 90 90 Units: Percentage of subjects number (confidence interval 95%)     Redness: Mild 2.3 (0.3 to 8.1) 2.2 (0.3 to 7.7) 2.3 (0.6 to 5.7) 0 (0.0 to 2.1)     Redness: Moderate 1.2 (0.0 to 6.3) 4.4 (1.2 to 10.9) 2.8 (0.9 to 6.5) 0 (0.0 to 2.1)     Redness: Severe 0 (0.0 to 4.2) 1.1 (0.0 to 6.0) 0.6 (0.0 to 3.1) 0 (0.0 to 2.1)     Redness: Grade 4 0 (0.0 to 4.2) 0 (0.0 to 4.0) 0 (0.0 to 2.1) 0 (0.0 to 2.1)     Swelling: Mild 3.5 (0.7 to 9.9) 5.5 (1.8 to 12.4) 4.5 (2.0 to 8.7) 0 (0.0 to 2.1)     Swelling: Moderate 0 (0.0 to 4.2) 0 (0.0 to 4.2) 0 (0.0 to 4.2) 0 (0.0 to 2.1)     Swelling: Severe 0 (0.0 to 4.2) 0 (0.0 to 4.0) 0 (0.0 to 2.1) 0 (0.0 to 2.1)     Swelling: Grade 4 0 (0.0 to 4.2) 0 (0.0 to 4.0) 0 (0.0 to 2.1) 0 (0.0 to 2.1)     Pain at injection site: Mild 53.5 (42.4 to 64.3) 54.9 (44.2 to 65.4) 54.2 (46.6 to 61.7) 8.5 (4.8 to 13.7)     Pain at injection site: Moderate 25.6 (16.8 to 36.1) 17.6 (10.4 to 27.0) 21.5 (15.7 to 28.3) 1.1 (0.1 to 4.0)     Pain at injection site: Severe 1.2 (0.0 to 6.3) 0 (0.0 to 4.0) 0.6 (0.0 to 3.1) 0 (0.0 to 2.1)     Pain at injection site: Grade 4 0 (0.0 to 4.2) 0 (0.0 to 4.0) 0 (0.0 to 2.1) 0 (0.0 to 2.1)
No statistical analyses for this end point

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

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Dose 1: Phase 2 Top of page
End point title	Percentage of Subjects With Systemic Events Within 7 Days After Dose 1: Phase 2 [31]
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 deg C categorised as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg 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 (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalisation for hypotensive shock). Diarrhea:mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (≥6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalisation). Number analyzed = Safety population with e-diary data after Dose 1.
End point type	Primary
End point timeframe	Within 7 Days after Dose 1
Notes [31] - 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 was planned for this endpoint
End point values BNT162b2 (30 mcg): 18-55 years of age BNT162b2 (30 mcg): 56-85 years of age Placebo:18-55 years of age Placebo: 56 to 85 years of age Number of subjects analysed 88 92 90 90 Units: Percentage of subjects number (confidence interval 95%)     Fever: 38.0°C to 38.4°C 0 (0.0 to 4.1) 0 (0.0 to 3.9) 0 (00 to 2.0) 0 (0.0 to 2.0)     Fever: >38.4°C to 38.9°C 3.4 (0.7 to 9.6) 0 (0.0 to 3.9) 1.7 (0.3 to 4.8) 0 (0.0 to 2.0)     Fever: >38.9°C to 40.0°C 0 (0.0 to 4.1) 0 (0.0 to 3.9) 0 (0.0 to 2.0) 0 (0.0 to 2.0)     Fever: >40.0°C 0 (0.0 to 4.1) 0 (0.0 to 3.9) 0 (0.0 to 2.0) 0 (0.0 to 2.0)     Fatigue: Mild 29.5 (20.3 to 40.2) 17.4 (10.3 to 26.7) 23.3 (17.4 to 30.2) 17.8 (12.5 to 24.2)     Fatigue: Moderate 20.5 (12.6 to 30.4) 18.5 (11.1 to 27.9) 19.4 (13.9 to 26.0) 9.4 (5.6 to 14.7)     Fatigue: Severe 0 (0.0 to 4.1) 0 (0.0 to 3.9) 0 (0.0 to 2.0) 0 (0.0 to 2.0)     Fatigue: Grade 4 0 (0.0 to 4.1) 0 (0.0 to 3.9) 0 (0.0 to 2.0) 0 (0.0 to 2.0)     Headache: Mild 20.5 (12.6 to 30.4) 22.8 (14.7 to 32.8) 21.7 (15.9 to 28.4) 15.6 (10.6 to 21.7)     Headache: Moderate 11.4 (5.6 to 19.9) 4.3 (1.2 to 10.8) 7.8 (4.3 to 12.7) 8.3 (4.7 to 13.4)     Headache: Severe 0 (0.0 to 4.1) 0 (0.0 to 3.9) 0 (0.0 to 2.0) 0.6 (0.0 to 3.1)     Headache: Grade 4 0 (0.0 to 4.1) 0 (0.0 to 3.9) 0 (0.0 to 2.0) 0 (0.0 to 2.0)     Chills: Mild 6.8 (2.5 to 14.3) 5.4 (1.8 to 12.2) 6.1 (3.1 to 10.7) 3.9 (1.6 to 7.8)     Chills: Moderate 2.3 (0.3 to 8.0) 2.2 (0.3 to 7.6) 2.2 (0.6 to 5.6) 0 (0.0 to 2.0)     Chills: Severe 0 (0.0 to 4.1) 0 (0.0 to 3.9) 0 (0.0 to 2.0) 0 (0.0 to 2.0)     Chills: Grade 4 0 (0.0 to 4.1) 0 (0.0 to 3.9) 0 (0.0 to 2.0) 0 (0.0 to 2.0)     Vomiting: Mild 0 (0.0 to 4.1) 0 (0.0 to 3.9) 0 (0.0 to 2.0) 0 (0.0 to 2.0)     Vomiting: Moderate 0 (0.0 to 4.1) 0 (0.0 to 3.9) 0 (0.0 to 2.0) 0 (0.0 to 2.0)     Vomiting: Severe 0 (0.0 to 4.1) 0 (0.0 to 3.9) 0 (0.0 to 2.0) 0 (0.0 to 2.0)     Vomiting: Grade 4 0 (0.0 to 4.1) 0 (0.0 to 3.9) 0 (0.0 to 2.0) 0 (0.0 to 2.0)     Diarrhea: Mild 10.2 (4.8 to 18.5) 9.8 (4.6 to 17.8) 10.0 (6.0 to 15.3) 10.6 (6.5 to 16.0)     Diarrhea: Moderate 6.8 (2.5 to 14.3) 2.2 (0.3 to 7.6) 4.4 (1.9 to 8.6) 1.7 (0.3 to 4.8)     Diarrhea: Severe 0 (0.0 to 4.1) 0 (0.0 to 3.9) 0 (0.0 to 2.0) 0 (0.0 to 2.0)     Diarrhea: Grade 4 0 (0.0 to 4.1) 0 (0.0 to 3.9) 0 (0.0 to 2.0) 0 (0.0 to 2.0)     New or worsened muscle pain: Mild 13.6 (7.2 to 22.6) 8.7 (3.8 to 16.4) 11.1 (6.9 to 16.6) 4.4 (1.9 to 8.6)     New or worsened muscle pain: Moderate 10.2 (4.8 to 18.5) 5.4 (1.8 to 12.2) 7.8 (4.3 to 12.7) 1.7 (0.3 to 4.8)     New or worsened muscle pain: Severe 0 (0.0 to 4.1) 0 (0.0 to 3.9) 0 (0.0 to 2.0) 0 (0.0 to 2.0)     New or worsened muscle pain: Grade 4 0 (0.0 to 4.1) 0 (0.0 to 3.9) 0 (0.0 to 2.0) 0 (0.0 to 2.0)     New or worsened joint pain: Mild 6.8 (2.5 to 14.3) 3.3 (0.7 to 9.2) 5.0 (2.3 to 9.3) 2.2 (0.6 to 5.6)     New or worsened joint pain: Moderate 2.3 (0.3 to 8.0) 1.1 (0.0 to 5.9) 1.7 (0.3 to 4.8) 1.7 (0.3 to 4.8)     New or worsened joint pain: Severe 0 (0.0 to 4.1) 0 (0.0 to 3.9) 0 (0.0 to 2.0) 0 (0.0 to 2.0)     New or worsened joint pain: Grade 4 0 (0.0 to 4.1) 0 (0.0 to 3.9) 0 (0.0 to 2.0) 0 (0.0 to 2.0)
No statistical analyses for this end point

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

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Dose 2: Phase 2 Top of page
End point title	Percentage of Subjects With Systemic Events Within 7 Days After Dose 2: Phase 2 [32]
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 deg C categorised as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg 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 (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalisation for hypotensive shock). Diarrhea:mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (≥6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalisation). Number analyzed = Safety population with e-diary data after Dose 2.
End point type	Primary
End point timeframe	Within 7 Days After Dose 2
Notes [32] - 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 was planned for this endpoint
End point values BNT162b2 (30 mcg): 18-55 years of age BNT162b2 (30 mcg): 56-85 years of age Placebo:18-55 years of age Placebo: 56 to 85 years of age Number of subjects analysed 86 91 90 90 Units: Percentage of subjects number (confidence interval 95%)     Fever: 38.0°C to 38.4°C 8.1 (3.3 to 16.1) 7.7 (3.1 to 15.2) 7.9 (4.4 to 12.9) 0 (0.0 to 2.1)     Fever: >38.4°C to 38.9°C 7.0 (2.6 to 14.6) 3.3 (0.7 to 9.3) 5.1 (2.4 to 9.4) 0 (0.0 to 2.1)     Fever: >38.9°C to 40.0°C 2.3 (0.3 to 8.1) 0 (0.0 to 4.0) 1.1 (0.1 to 4.0) 0 (0.0 to 2.1)     Fever: >40.0°C 0 (0.0 to 4.2) 0 (0.0 to 4.0) 0 (0.0 to 2.1) 0 (0.0 to 2.1)     Fatigue: Mild 16.3 (9.2 to 25.8) 24.2 (15.8 to 34.3) 20.3 (14.7 to 27.0) 11.9 (7.5 to 17.7)     Fatigue: Moderate 37.2 (27.0 to 48.3) 26.4 (17.7 to 36.7) 31.6 (24.9 to 39.0) 8.5 (4.8 to 13.7)     Fatigue: Severe 5.8 (1.9 to 13.0) 2.2 (0.3 to 7.7) 4.0 (1.6 to 8.0) 0 (0.0 to 2.1)     Fatigue: Grade 4 0 (0.0 to 4.2) 0 (0.0 to 4.0) 0 (0.0 to 2.1) 0 (0.0 to 2.1)     Headache: Mild 22.1 (13.9 to 32.3) 19.8 (12.2 to 29.4) 20.9 (15.2 to 27.6) 9.7 (5.7 to 15.0)     Headache: Moderate 24.4 (15.8 to 34.9) 15.4 (8.7 to 24.5) 19.8 (14.2 to 26.4) 6.3 (3.2 to 10.9)     Headache: Severe 4.7 (1.3 to 11.5) 1.1 (0.0 to 6.0) 2.8 (0.9 to 6.5) 0.6 (0.0 to 3.1)     Headache: Grade 4 0 (0.0 to 4.2) 0 (0.0 to 4.0) 0 (0.0 to 2.1) 0 (0.0 to 2.1)     Chills: Mild 22.1 (13.9 to 32.3) 9.9 (4.6 to 17.9) 15.8 (10.8 to 22.0) 1.7 (0.4 to 4.9)     Chills: Moderate 15.1 (8.3 to 24.5) 9.9 (4.6 to 17.9) 12.4 (8.0 to 18.2) 0.6 (0.0 to 3.1)     Chills: Severe 3.5 (0.7 to 9.9) 1.1 (0.0 to 6.0) 2.3 (0.6 to 5.7) 0 (0.0 to 2.1)     Chills: Grade 4 0 (0.0 to 4.2) 0 (0.0 to 4.0) 0 (0.0 to 2.1) 0 (0.0 to 2.1)     Vomiting: Mild 2.3 (0.3 to 8.1) 0 (0.0 to 4.0) 1.1 (0.1 to 4.0) 0.6 (0.0 to 3.1)     Vomiting: Moderate 0 (0.0 to 4.2) 0 (0.0 to 4.0) 0 (0.0 to 2.1) 0 (0.0 to 2.1)     Vomiting: Severe 0 (0.0 to 4.2) 0 (0.0 to 4.0) 0 (0.0 to 2.1) 0 (0.0 to 2.1)     Vomiting: Grade 4 0 (0.0 to 4.2) 0 (0.0 to 4.0) 0 (0.0 to 2.1) 0 (0.0 to 2.1)     Diarrhea: Mild 16.3 (9.2 to 25.8) 6.6 (2.5 to 13.8) 11.3 (7.0 to 16.9) 6.8 (3.6 to 11.6)     Diarrhea: Moderate 3.5 (0.7 to 9.9) 2.2 (0.3 to 7.7) 2.8 (0.9 to 6.5) 1.1 (0.1 to 4.0)     Diarrhea: Severe 0 (0.0 to 4.2) 0 (0.0 to 4.0) 0 (0.0 to 2.1) 0 (0.0 to 2.1)     Diarrhea: Grade 4 0 (0.0 to 4.2) 0 (0.0 to 4.0) 0 (0.0 to 2.1) 0 (0.0 to 2.1)     New or worsened muscle pain: Mild 20.9 (12.9 to 31.0) 12.1 (6.2 to 20.6) 16.4 (11.3 to 22.7) 2.3 (0.6 to 5.7)     New or worsened muscle pain: Moderate 22.1 (13.9 to 32.3) 15.4 (8.7 to 24.5) 18.6 (13.2 to 25.2) 1.1 (0.1 to 4.0)     New or worsened muscle pain: Severe 0 (0.0 to 4.2) 1.1 (0.0 to 6.0) 1.7 (0.4 to 4.9) 0 (0.0 to 2.1)     New or worsened muscle pain: Grade 4 0 (0.0 to 4.2) 0 (0.0 to 4.0) 0 (0.0 to 2.1) 0 (0.0 to 2.1)     New or worsened joint pain: Mild 9.3 (4.1 to 17.5) 8.8 (3.9 to 16.6) 9.0 (5.3 to 14.3) 2.3 (0.6 to 5.7)     New or worsened joint pain: Moderate 8.1 (3.3 to 16.1) 7.7 (3.1 to 15.2) 7.9 (4.4 to 12.9) 2.3 (0.6 to 5.7)     New or worsened joint pain: Severe 0 (0.0 to 4.2) 0 (0.0 to 4.0) 0 (0.0 to 2.1) 0 (0.0 to 2.1)     New or worsened joint pain: Grade 4 0 (0.0 to 4.2) 0 (0.0 to 4.0) 0 (0.0 to 2.1) 0 (0.0 to 2.1)
No statistical analyses for this end point

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

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Booster Dose: BNT162b2 Experienced Subjects who Were Rerandomised to Receive 1 Booster Dose Top of page
End point title	Percentage of Subjects With Local Reactions Within 7 Days After Booster Dose: BNT162b2 Experienced Subjects who Were Rerandomised to Receive 1 Booster Dose [33]
End point description	Local reactions included redness, swelling and, pain at the injection site, recorded by 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 analysed = safety population with e-diary data after booster dose. HIV positive subjects were excluded.
End point type	Primary
End point timeframe	Within 7 Days After Booster Dose
Notes [33] - 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 was planned for this endpoint
End point values BNT162b2 (30 mcg) BNT162b2SA (30 mcg) Number of subjects analysed 289 298 Units: Percentage of subjects number (confidence interval 95%)     Redness: Mild 3.5 (1.7 to 6.3) 1.7 (0.5 to 3.9)     Redness: Moderate 2.4 (1.0 to 4.9) 3.0 (1.4 to 5.7)     Redness: Severe 0 (0.0 to 1.3) 0.3 (0.0 to 1.9)     Redness: Grade 4 0 (0.0 to 1.3) 0 (0.0 to 1.2)     Swelling: Mild 4.5 (2.4 to 7.6) 4.4 (2.3 to 7.3)     Swelling: Moderate 3.1 (1.4 to 5.8) 2.0 (0.7 to 4.3)     Swelling: Severe 0.3 (0.0 to 1.9) 0.3 (0.0 to 1.9)     Swelling: Grade 4 0 (0.0 to 1.3) 0 (0.0 to 1.2)     Pain at injection site: Mild 60.2 (54.3 to 65.9) 53.0 (47.2 to 58.8)     Pain at injection site: Moderate 22.5 (17.8 to 27.7) 28.9 (23.8 to 34.4)     Pain at injection site: Severe 0.3 (0.0 to 1.9) 1.0 (0.2 to 2.9)     Pain at injection site: Grade 4 0 (0.0 to 1.3) 0 (0.0 to 1.2)
No statistical analyses for this end point

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Booster Dose: BNT162b2 Experienced Subjects who Were Rerandomised to Receive 1 Booster Dose Top of page

Primary: Percentage of Subjects Reporting Adverse Events From Dose 1 to 7 Days After Dose 2: Phase 2 Top of page
End point title	Percentage of Subjects Reporting Adverse Events From Dose 1 to 7 Days After Dose 2: Phase 2 [34]
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 to 7 Days After Dose 2
Notes [34] - 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 was planned for this endpoint
End point values BNT162b2 (30 mcg): 18-55 years of age BNT162b2 (30 mcg): 56-85 years of age Placebo:18-55 years of age Placebo: 56 to 85 years of age Number of subjects analysed 88 92 90 90 Units: Percentage of subjects     number (confidence interval 95%) 9.1 (4.0 to 17.1) 4.3 (1.2 to 10.8) 6.7 (3.5 to 11.4) 10.0 (6.0 to 15.3)
No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Adverse Events From Dose 1 to 7 Days After Dose 2: Phase 2 Top of page

Primary: Percentage of Subjects Reporting Serious Adverse Events From Dose 1 to 7 Days After Dose 2: Phase 2 Top of page
End point title	Percentage of Subjects Reporting Serious Adverse Events From Dose 1 to 7 Days After Dose 2: Phase 2 [35]
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 7 Days After Dose 2
Notes [35] - 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 was planned for this endpoint
End point values BNT162b2 (30 mcg): 18-55 years of age BNT162b2 (30 mcg): 56-85 years of age Placebo:18-55 years of age Placebo: 56 to 85 years of age Number of subjects analysed 88 92 90 90 Units: Percentage of subjects     number (confidence interval 95%) 1.1 (0.0 to 6.2) 0 (0.0 to 3.9) 0.6 (0.0 to 3.1) 0 (0.0 to 2.0)
No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Serious Adverse Events From Dose 1 to 7 Days After Dose 2: Phase 2 Top of page

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Booster Dose 1: BNT162b2 Experienced Subjects who Were Rerandomised to Receive 1 Booster Dose Top of page
End point title	Percentage of Subjects With Systemic Events Within 7 Days After Booster Dose 1: BNT162b2 Experienced Subjects who Were Rerandomised to Receive 1 Booster Dose [36]
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 deg C categorised as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg 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 (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalisation for hypotensive shock). Diarrhea:mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (≥6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalisation). Number analyzed = Safety population with e-diary data after booster dose. HIV positive subjects were excluded.
End point type	Primary
End point timeframe	Within 7 Days After Booster Dose
Notes [36] - 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 was planned for this endpoint
End point values BNT162b2 (30 mcg) BNT162b2SA (30 mcg) Number of subjects analysed 289 298 Units: Percentage of subjects number (confidence interval 95%)     Fever: 38.0°C to 38.4°C 4.2 (2.2 to 7.1) 4.0 (2.1 to 6.9)     Fever: >38.4°C to 38.9°C 4.2 (2.2 to 7.1) 4.0 (2.1 to 6.9)     Fever: >38.9°C to 40.0°C 0.3 (0.0 to 1.9) 4.0 (2.1 to 6.9)     Fever: >40.0°C 0 (0.0 to 1.3) 1.3 (0.4 to 3.4)     Fatigue: Mild 23.5 (18.8 to 28.9) 23.8 (19.1 to 29.1)     Fatigue: Moderate 35.6 (30.1 to 41.5) 41.3 (35.6 to 47.1)     Fatigue: Severe 4.5 (2.4 to 7.6) 4.7 (2.6 to 7.8)     Fatigue: Grade 4 0 (0.0 to 1.3) 0 (0.0 to 1.2)     Headache: Mild 28.7 (23.6 to 34.3) 28.2 (23.2 to 33.7)     Headache: Moderate 18.7 (14.4 to 23.7) 23.5 (18.8 to 28.7)     Headache: Severe 1.0 (0.2 to 3.0) 2.0 (0.7 to 4.3)     Headache: Grade 4 0 (0.0 to 1.3) 0 (0.0 to 1.2)     Chills: Mild 12.8 (9.2 to 17.2) 18.5 (14.2 to 23.3)     Chills: Moderate 15.2 (11.3 to 19.9) 16.1 (12.1 to 20.8)     Chills: Severe 1.0 (0.2 to 3.0) 2.0 (0.7 to 4.3)     Chills: Grade 4 0 (0.0 to 1.3) 0 (0.0 to 1.2)     Vomiting: Mild 1.7 (0.6 to 4.0) 0.7 (0.1 to 2.4)     Vomiting: Moderate 0 (0.0 to 1.3) 0 (0.0 to 1.2)     Vomiting: Severe 0 (0.0 to 1.3) 0 (0.0 to 1.2)     Vomiting: Grade 4 0 (0.0 to 1.3) 0 (0.0 to 1.2)     Diarrhea: Mild 7.3 (4.6 to 10.9) 8.1 (5.2 to 11.7)     Diarrhea: Moderate 1.4 (0.4 to 3.5) 1.3 (0.4 to 3.4)     Diarrhea: Severe 0 (0.0 to 1.3) 0.3 (0.0 to 1.9)     Diarrhea: Grade 4 0 (0.0 to 1.3) 0 (0.0 to 1.2)     New or worsened muscle pain: Mild 18.0 (13.7 to 22.9) 14.8 (10.9 to 19.3)     New or worsened muscle pain: Moderate 19.7 (15.3 to 24.8) 21.8 (17.3 to 26.9)     New or worsened muscle pain: Severe 1.4 (0.4 to 3.5) 2.0 (0.7 to 4.3)     New or worsened muscle pain: Grade 4 0 (0.0 to 1.3) 0 (0.0 to 1.2)     New or worsened joint pain: Mild 12.5 (8.9 to 16.8) 10.4 (7.2 to 14.4)     New or worsened joint pain: Moderate 12.5 (8.9 to 16.8) 11.4 (8.0 to 15.6)     New or worsened joint pain: Severe 0.3 (0.0 to 1.9) 0.7 (0.1 to 2.4)     New or worsened joint pain: Grade 4 0 (0.0 to 1.3) 0 (0.0 to 1.2)
No statistical analyses for this end point

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Booster Dose 1: BNT162b2 Experienced Subjects who Were Rerandomised to Receive 1 Booster Dose Top of page

Primary: Percentage of Subjects Reporting Adverse Events From First Booster Dose to 1 Month After Booster Dose: BNT162b2 Experienced Subjects who Were Rerandomised to Receive 1 Booster Dose Top of page
End point title	Percentage of Subjects Reporting Adverse Events From First Booster Dose to 1 Month After Booster Dose: BNT162b2 Experienced Subjects who Were Rerandomised to Receive 1 Booster Dose [37]
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. Number analysed = safety population who received booster dose. HIV positive subjects were excluded.
End point type	Primary
End point timeframe	From First Booster Dose to 1 Month After Booster Dose
Notes [37] - 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 was planned for this endpoint
End point values BNT162b2 (30 mcg) BNT162b2SA (30 mcg) Number of subjects analysed 306 315 Units: Percentage of subjects     number (confidence interval 95%) 15.0 (11.2 to 19.5) 10.8 (7.6 to 14.8)
No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Adverse Events From First Booster Dose to 1 Month After Booster Dose: BNT162b2 Experienced Subjects who Were Rerandomised to Receive 1 Booster Dose Top of page

Primary: Percentage of Subjects Reporting Serious Adverse Events From First Booster Dose to 6 Months After Booster Dose: BNT162b2 Experienced Subjects who Were Rerandomised to Receive 1 Booster Dose Top of page
End point title	Percentage of Subjects Reporting Serious Adverse Events From First Booster Dose to 6 Months After Booster Dose: BNT162b2 Experienced Subjects who Were Rerandomised to Receive 1 Booster Dose [38]
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. Number analysed = safety population who received booster dose. HIV positive subjects were excluded.
End point type	Primary
End point timeframe	From First Booster Dose to 6 Months After Booster Dose
Notes [38] - 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 was planned for this endpoint
End point values BNT162b2 (30 mcg) BNT162b2SA (30 mcg) Number of subjects analysed 306 315 Units: Percentage of subjects     number (confidence interval 95%) 0.7 (0.1 to 2.3) 0.6 (0.1 to 2.3)
No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Serious Adverse Events From First Booster Dose to 6 Months After Booster Dose: BNT162b2 Experienced Subjects who Were Rerandomised to Receive 1 Booster Dose Top of page

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Booster Dose 1: BNT162b2 Experienced Subjects Assigned to Receive 2 Booster Doses of BNT162b2SA Top of page
End point title	Percentage of Subjects With Local Reactions Within 7 Days After Booster Dose 1: BNT162b2 Experienced Subjects Assigned to Receive 2 Booster Doses of BNT162b2SA [39]
End point description	Local reactions included redness, swelling and, pain at the injection site, recorded by 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 analysed = safety population with e-diary data after booster dose. HIV positive subjects were excluded.
End point type	Primary
End point timeframe	Within 7 Days After Booster Dose 1
Notes [39] - 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 was planned for this endpoint
End point values BNT162b2SA (30 mcg), 2 doses Number of subjects analysed 30 Units: Percentage of subjects number (confidence interval 95%)     Redness: Mild 0 (0.0 to 11.6)     Redness: Moderate 0 (0.0 to 11.6)     Redness: Severe 0 (0.0 to 11.6)     Redness: Grade 4 0 (0.0 to 11.6)     Swelling: Mild 0 (0.0 to 11.6)     Swelling: Moderate 0 (0.0 to 11.6)     Swelling: Severe 0 (0.0 to 11.6)     Swelling: Grade 4 0 (0.0 to 11.6)     Pain at injection site: Mild 56.7 (37.4 to 74.5)     Pain at injection site: Moderate 20.0 (7.7 to 38.6)     Pain at injection site: Severe 0 (0.0 to 11.6)     Pain at injection site: Grade 4 0 (0.0 to 11.6)
No statistical analyses for this end point

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Booster Dose 1: BNT162b2 Experienced Subjects Assigned to Receive 2 Booster Doses of BNT162b2SA Top of page

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Booster Dose 2: BNT162b2 Experienced Subjects Assigned to Receive 2 Booster Doses of BNT162b2SA Top of page
End point title	Percentage of Subjects With Local Reactions Within 7 Days After Booster Dose 2: BNT162b2 Experienced Subjects Assigned to Receive 2 Booster Doses of BNT162b2SA [40]
End point description	Local reactions included redness, swelling and, pain at the injection site, recorded by 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 analysed = safety population with e-diary data after booster Dose 2. HIV positive subjects were excluded.
End point type	Primary
End point timeframe	Within 7 Days after Booster Dose 2
Notes [40] - 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 was planned for this endpoint
End point values BNT162b2 (30 mcg) Number of subjects analysed 28 Units: Percentage of subjects number (confidence interval 95%)     Redness: Mild 0 (0.0 to 12.3)     Redness: Moderate 0 (0.0 to 12.3)     Redness: Severe 0 (0.0 to 12.3)     Redness: Grade 4 0 (0.0 to 12.3)     Swelling: Mild 0 (0.0 to 12.3)     Swelling: Moderate 0 (0.0 to 12.3)     Swelling: Severe 0 (0.0 to 12.3)     Swelling: Grade 4 0 (0.0 to 12.3)     Pain at injection site: Mild 50.0 (30.6 to 69.4)     Pain at injection site: Moderate 17.9 (6.1 to 36.9)     Pain at injection site: Severe 0 (0.0 to 12.3)     Pain at injection site: Grade 4 0 (0.0 to 12.3)
No statistical analyses for this end point

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Booster Dose 2: BNT162b2 Experienced Subjects Assigned to Receive 2 Booster Doses of BNT162b2SA Top of page

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Booster Dose 1: BNT162b2 Experienced Subjects Assigned to Receive 2 Booster Doses of BNT162b2SA Top of page
End point title	Percentage of Subjects With Systemic Events Within 7 Days After Booster Dose 1: BNT162b2 Experienced Subjects Assigned to Receive 2 Booster Doses of BNT162b2SA [41]
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 deg C categorised as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg 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 (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalisation for hypotensive shock). Diarrhea:mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (≥6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalisation). Number analyzed = Safety population with e-diary data after booster Dose 1. HIV positive subjects were excluded.
End point type	Primary
End point timeframe	Within 7 Days After Booster Dose 1
Notes [41] - 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 was planned for this endpoint
End point values BNT162b2SA (30 mcg), 2 doses Number of subjects analysed 30 Units: Percentage of subjects number (confidence interval 95%)     Fever: 38.0°C to 38.4°C 3.3 (0.1 to 17.2)     Fever: >38.4°C to 38.9°C 6.7 (0.8 to 22.1)     Fever: >38.9°C to 40.0°C 3.3 (0.1 to 17.2)     Fever: >40.0°C 0 (0.0 to 11.6)     Fatigue: Mild 26.7 (12.3 to 45.9)     Fatigue: Moderate 33.3 (17.3 to 52.8)     Fatigue: Severe 3.3 (0.1 to 17.2)     Fatigue: Grade 4 0 (0.0 to 11.6)     Headache: Mild 33.3 (17.3 to 52.8)     Headache: Moderate 20.0 (7.7 to 38.6)     Headache: Severe 0 (0.0 to 11.6)     Headache: Grade 4 0 (0.0 to 11.6)     Chills: Mild 13.3 (3.8 to 30.7)     Chills: Moderate 16.7 (5.6 to 34.7)     Chills: Severe 3.3 (0.1 to 17.2)     Chills: Grade 4 0 (0.0 to 11.6)     Vomiting: Mild 3.3 (0.1 to 17.2)     Vomiting: Moderate 0 (0.0 to 11.6)     Vomiting: Severe 0 (0.0 to 11.6)     Vomiting: Grade 4 0 (0.0 to 11.6)     Diarrhea: Mild 6.7 (0.8 to 22.1)     Diarrhea: Moderate 3.3 (0.1 to 17.2)     Diarrhea: Severe 0 (0.0 to 11.6)     Diarrhea: Grade 4 0 (0.0 to 11.6)     New or worsened muscle pain: Mild 20.0 (7.0 to 38.6)     New or worsened muscle pain: Moderate 20.0 (7.0 to 38.6)     New or worsened muscle pain: Severe 0 (0.0 to 11.6)     New or worsened muscle pain: Grade 4 0 (0.0 to 11.6)     New or worsened joint pain: Mild 13.3 (3.3 to 38.7)     New or worsened joint pain: Moderate 20.0 (7.7 to 38.6)     New or worsened joint pain: Severe 0 (0.0 to 11.6)     New or worsened joint pain: Grade 4 0 (0.0 to 11.6)
No statistical analyses for this end point

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Booster Dose 1: BNT162b2 Experienced Subjects Assigned to Receive 2 Booster Doses of BNT162b2SA Top of page

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Booster Dose 2: BNT162b2 Experienced Subjects Assigned to Receive 2 Booster Doses of BNT162b2SA Top of page
End point title	Percentage of Subjects With Systemic Events Within 7 Days After Booster Dose 2: BNT162b2 Experienced Subjects Assigned to Receive 2 Booster Doses of BNT162b2SA [42]
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 deg C categorised as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg 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 (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalisation for hypotensive shock). Diarrhea:mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (≥6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalisation). Number analyzed = Safety population with e-diary data after booster Dose 2. HIV positive subjects were excluded.
End point type	Primary
End point timeframe	Within 7 Days After Booster Dose 2
Notes [42] - 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 was planned for this endpoint
End point values BNT162b2SA (30 mcg), 2 doses Number of subjects analysed 28 Units: Percentage of subjects number (confidence interval 95%)     Fever: 38.0°C to 38.4°C 3.6 (0.1 to 18.3)     Fever: >38.4°C to 38.9°C 3.6 (0.1 to 18.3)     Fever: >38.9°C to 40.0°C 3.6 (0.1 to 16.3)     Fever: >40.0°C 0 (0.0 to 12.3)     Fatigue: Mild 32.1 (15.9 to 52.4)     Fatigue: Moderate 21.4 (8.3 to 41.0)     Fatigue: Severe 0 (0.0 to 12.3)     Fatigue: Grade 4 0 (0.0 to 12.3)     Headache: Mild 25.0 (10.7 to 44.9)     Headache: Moderate 17.9 (6.1 to 36.9)     Headache: Severe 0 (0.0 to 12.3)     Headache: Grade 4 0 (0.0 to 12.3)     Chills: Mild 14.3 (4.0 to 32.7)     Chills: Moderate 14.3 (4.0 to 32.7)     Chills: Severe 0 (0.0 to 12.3)     Chills: Grade 4 0 (0.0 to 12.3)     Vomiting: Mild 0 (0.0 to 12.3)     Vomiting: Moderate 0 (0.0 to 12.3)     Vomiting: Severe 0 (0.0 to 12.3)     Vomiting: Grade 4 0 (0.0 to 12.3)     Diarrhea: Mild 14.3 (4.0 to 32.7)     Diarrhea: Moderate 0 (0.0 to 12.3)     Diarrhea: Severe 0 (0.0 to 12.3)     Diarrhea: Grade 4 0 (0.0 to 12.3)     New or worsened muscle pain: Mild 14.3 (4.0 to 32.7)     New or worsened muscle pain: Moderate 21.4 (8.3 to 41.0)     New or worsened muscle pain: Severe 0 (0.0 to 12.3)     New or worsened muscle pain: Grade 4 0 (0.0 to 12.3)     New or worsened joint pain: Mild 17.9 (6.1 to 36.9)     New or worsened joint pain: Moderate 10.7 (2.3 to 28.2)     New or worsened joint pain: Severe 0 (0.0 to 12.3)     New or worsened joint pain: Grade 4 0 (0.0 to 12.3)
No statistical analyses for this end point

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Booster Dose 2: BNT162b2 Experienced Subjects Assigned to Receive 2 Booster Doses of BNT162b2SA Top of page

Primary: Percentage of Subjects Reporting Adverse Events From First Booster Dose to 1 Month After Second Booster Dose: BNT162b2 Experienced Subjects Assigned to Receive 2 Booster Doses of BNT162b2SA Top of page
End point title	Percentage of Subjects Reporting Adverse Events From First Booster Dose to 1 Month After Second Booster Dose: BNT162b2 Experienced Subjects Assigned to Receive 2 Booster Doses of BNT162b2SA [43]
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. Number analysed = safety population who received booster dose. HIV positive subjects were excluded.
End point type	Primary
End point timeframe	From First Booster Dose to 1 Month After Second Booster Dose
Notes [43] - 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 was planned for this endpoint
End point values BNT162b2SA (30 mcg), 2 doses Number of subjects analysed 30 Units: Percentage of subjects     number (confidence interval 95%) 20.0 (7.7 to 38.6)
No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Adverse Events From First Booster Dose to 1 Month After Second Booster Dose: BNT162b2 Experienced Subjects Assigned to Receive 2 Booster Doses of BNT162b2SA Top of page

Primary: Percentage of Subjects Reporting Serious Adverse Events From First Booster Dose to 5 Months After Second Booster Dose: BNT162b2 Experienced Subjects Assigned to Receive 2 Booster Doses of BNT162b2SA Top of page
End point title	Percentage of Subjects Reporting Serious Adverse Events From First Booster Dose to 5 Months After Second Booster Dose: BNT162b2 Experienced Subjects Assigned to Receive 2 Booster Doses of BNT162b2SA [44]
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. Number analysed = safety population who received booster dose. HIV positive subjects were excluded.
End point type	Primary
End point timeframe	From First Booster Dose to 5 Months After Second Booster Dose
Notes [44] - 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 was planned for this endpoint
End point values BNT162b2SA (30 mcg), 2 doses Number of subjects analysed 30 Units: Percentage of subjects     number (confidence interval 95%) 3.3 (0.1 to 17.2)
No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Serious Adverse Events From First Booster Dose to 5 Months After Second Booster Dose: BNT162b2 Experienced Subjects Assigned to Receive 2 Booster Doses of BNT162b2SA Top of page

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Dose 1: BNT162b2 Naive Subjects who Were Enrolled to Receive BNT162b2SA Top of page
End point title	Percentage of Subjects With Local Reactions Within 7 Days After Dose 1: BNT162b2 Naive Subjects who Were Enrolled to Receive BNT162b2SA [45]
End point description	Local reactions included redness, swelling and, pain at the injection site, recorded by 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 analysed = safety population with e-diary data after Dose 1. HIV positive subjects were excluded.
End point type	Primary
End point timeframe	Within 7 Days After Dose 1
Notes [45] - 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 was planned for this endpoint
End point values BNT162b2SA (30 mcg) Number of subjects analysed 313 Units: Percentage of subjects number (confidence interval 95%)     Redness: Mild 1.6 (0.5 to 3.7)     Redness: Moderate 0.3 (0.0 to 1.8)     Redness: Severe 0 (0.0 to 1.2)     Redness: Grade 4 0 (0.0 to 1.2)     Swelling: Mild 1.9 (0.7 to 4.1)     Swelling: Moderate 1.6 (0.5 to 3.7)     Swelling: Severe 0 (0.0 to 1.2)     Swelling: Grade 4 0 (0.0 to 1.2)     Pain at injection site: Mild 68.1 (62.6 to 73.2)     Pain at injection site: Moderate 14.7 (11.0 to 19.1)     Pain at injection site: Severe 0.3 (0.0 to 1.8)     Pain at injection site: Grade 4 0 (0.0 to 1.2)
No statistical analyses for this end point

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Dose 1: BNT162b2 Naive Subjects who Were Enrolled to Receive BNT162b2SA Top of page

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Dose 2: BNT162b2 Naive Subjects who Were Enrolled to Receive BNT162b2SA Top of page
End point title	Percentage of Subjects With Local Reactions Within 7 Days After Dose 2: BNT162b2 Naive Subjects who Were Enrolled to Receive BNT162b2SA [46]
End point description	Local reactions included redness, swelling and, pain at the injection site, recorded by 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 analysed = safety population with e-diary data after Dose 2. HIV positive subjects were excluded.
End point type	Primary
End point timeframe	Within 7 Days After Dose 2
Notes [46] - 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 was planned for this endpoint
End point values BNT162b2SA (30 mcg) Number of subjects analysed 316 Units: Percentage of subjects number (confidence interval 95%)     Redness: Mild 2.8 (1.3 to 5.3)     Redness: Moderate 1.9 (0.7 to 4.1)     Redness: Severe 0.3 (0.0 to 1.8)     Redness: Grade 4 0 (0.0 to 1.2)     Swelling: Mild 2.8 (1.3 to 5.3)     Swelling: Moderate 2.2 (0.9 to 4.5)     Swelling: Severe 0 (0.0 to 1.2)     Swelling: Grade 4 0 (0.0 to 1.2)     Pain at injection site: Mild 53.5 (47.8 to 59.1)     Pain at injection site: Moderate 19.3 (15.1 to 24.1)     Pain at injection site: Severe 0.3 (0.0 to 1.8)     Pain at injection site: Grade 4 0 (0.0 to 1.2)
No statistical analyses for this end point

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Dose 2: BNT162b2 Naive Subjects who Were Enrolled to Receive BNT162b2SA Top of page

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Dose 1: BNT162b2 Naive Subjects who Were Enrolled to Receive BNT162b2SA Top of page
End point title	Percentage of Subjects With Systemic Events Within 7 Days After Dose 1: BNT162b2 Naive Subjects who Were Enrolled to Receive BNT162b2SA [47]
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 deg C categorised as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg 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 (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalisation for hypotensive shock). Diarrhea:mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (≥6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalisation). Number analyzed = Safety population with e-diary data after Dose 1. HIV positive subjects were excluded.
End point type	Primary
End point timeframe	Within 7 Days After Dose 1
Notes [47] - 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 was planned for this endpoint
End point values BNT162b2SA (30 mcg) Number of subjects analysed 313 Units: Percentage of subjects number (confidence interval 95%)     Fever: 38.0°C to 38.4°C 1.0 (0.2 to 3.8)     Fever: >38.4°C to 38.9°C 0 (0.0 to 1.2)     Fever: >38.9°C to 40.0°C 0 (0.0 to 1.2)     Fever: >40.0°C 0 (0.0 to 1.2)     Fatigue: Mild 27.8 (22.9 to 33.1)     Fatigue: Moderate 21.1 (16.7 to 26.0)     Fatigue: Severe 0.6 (0.1 to 2.3)     Fatigue: Grade 4 0 (0.0 to 1.2)     Headache: Mild 22.0 (17.6 to 27.1)     Headache: Moderate 9.9 (6.8 to 13.8)     Headache: Severe 0.3 (0.0 to 1.8)     Headache: Grade 4 0 (0.0 to 1.2)     Chills: Mild 4.8 (2.7 to 7.8)     Chills: Moderate 1.6 (0.5 to 3.7)     Chills: Severe 0.3 (0.0 to 1.8)     Chills: Grade 4 0 (0.0 to 1.2)     Vomiting: Mild 1.3 (0.3 to 3.2)     Vomiting: Moderate 0 (0.0 to 1.2)     Vomiting: Severe 0 (0.0 to 1.2)     Vomiting: Grade 4 0 (0.0 to 1.2)     Diarrhea: Mild 6.7 (4.2 to 10.1)     Diarrhea: Moderate 1.3 (0.3 to 3.2)     Diarrhea: Severe 0.3 (0.0 to 1.8)     Diarrhea: Grade 4 0 (0.0 to 1.2)     New or worsened muscle pain: Mild 6.4 (3.9 to 9.7)     New or worsened muscle pain: Moderate 5.8 (3.4 to 8.9)     New or worsened muscle pain: Severe 0 (0.0 to 1.2)     New or worsened muscle pain: Grade 4 0 (0.0 to 1.2)     New or worsened joint pain: Mild 2.9 (1.3 to 5.4)     New or worsened joint pain: Moderate 1.9 (0.7 to 4.1)     New or worsened joint pain: Severe 0 (0.0 to 1.2)     New or worsened joint pain: Grade 4 0 (0.0 to 1.2)
No statistical analyses for this end point

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Dose 1: BNT162b2 Naive Subjects who Were Enrolled to Receive BNT162b2SA Top of page

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Dose 2: BNT162b2 Naive Subjects who Were Enrolled to Receive BNT162b2SA Top of page
End point title	Percentage of Subjects With Systemic Events Within 7 Days After Dose 2: BNT162b2 Naive Subjects who Were Enrolled to Receive BNT162b2SA [48]
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 deg C categorised as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg 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 (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalisation for hypotensive shock). Diarrhea:mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (≥6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalisation). Number analyzed = Safety population with e-diary data after Dose 2. HIV positive subjects were excluded.
End point type	Primary
End point timeframe	Within 7 Days After Dose 2
Notes [48] - 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 was planned for this endpoint
End point values BNT162b2SA (30 mcg) Number of subjects analysed 316 Units: Percentage of subjects number (confidence interval 95%)     Fever: 38.0°C to 38.4°C 1.6 (0.5 to 3.7)     Fever: >38.4°C to 38.9°C 1.6 (0.5 to 3.7)     Fever: >38.9°C to 40.0°C 0.6 (0.1 to 2.3)     Fever: >40.0°C 0 (0.0 to 1.2)     Fatigue: Mild 25.3 (20.6 to 30.5)     Fatigue: Moderate 36.1 (30.8 to 41.6)     Fatigue: Severe 4.1 (2.2 to 6.9)     Fatigue: Grade 4 0 (0.0 to 1.2)     Headache: Mild 29.7 (24.8 to 35.1)     Headache: Moderate 17.1 (13.1 to 21.7)     Headache: Severe 0.9 (0.2 to 2.7)     Headache: Grade 4 0 (0.0 to 1.2)     Chills: Mild 13.9 (10.3 to 18.2)     Chills: Moderate 12.7 (9.2 to 16.8)     Chills: Severe 0.9 (0.2 to 2.7)     Chills: Grade 4 0 (0.0 to 1.2)     Vomiting: Mild 0.9 (0.2 to 2.7)     Vomiting: Moderate 0 (0.0 to 1.2)     Vomiting: Severe 0 (0.0 to 1.2)     Vomiting: Grade 4 0 (0.0 to 1.2)     Diarrhea: Mild 6.0 (3.7 to 9.2)     Diarrhea: Moderate 0.6 (0.1 to 2.3)     Diarrhea: Severe 0 (0.0 to 1.2)     Diarrhea: Grade 4 0 (0.0 to 1.2)     New or worsened muscle pain: Mild 13.0 (9.5 to 17.2)     New or worsened muscle pain: Moderate 16.1 (12.3 to 20.7)     New or worsened muscle pain: Severe 1.3 (0.3 to 3.2)     New or worsened muscle pain: Grade 4 0 (0.0 to 1.2)     New or worsened joint pain: Mild 7.9 (5.2 to 11.5)     New or worsened joint pain: Moderate 12.7 (9.2 to 16.8)     New or worsened joint pain: Severe 0 (0.0 to 1.2)     New or worsened joint pain: Grade 4 0 (0.0 to 1.2)
No statistical analyses for this end point

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Dose 2: BNT162b2 Naive Subjects who Were Enrolled to Receive BNT162b2SA Top of page

Primary: Percentage of Subjects Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: BNT162b2-Naïve Subjects who Were Enrolled to Receive BNT162b2SA Top of page
End point title	Percentage of Subjects Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: BNT162b2-Naïve Subjects who Were Enrolled to Receive BNT162b2SA [49]
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. HIV positive subjects were excluded.
End point type	Primary
End point timeframe	From Dose 1 Through 1 Month After Dose 2
Notes [49] - 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 was planned for this endpoint
End point values BNT162b2SA (30 mcg) Number of subjects analysed 324 Units: Percentage of subjects     number (confidence interval 95%) 14.2 (10.6 to 18.5)
No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: BNT162b2-Naïve Subjects who Were Enrolled to Receive BNT162b2SA Top of page

Primary: Percentage of Subjects Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: BNT162b2-Naïve Subjects who Were Enrolled to Receive BNT162b2SA Top of page
End point title	Percentage of Subjects Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: BNT162b2-Naïve Subjects who Were Enrolled to Receive BNT162b2SA [50]
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. HIV positive subjects were excluded.
End point type	Primary
End point timeframe	From Dose 1 to 6 Months After Dose 2
Notes [50] - 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 was planned for this endpoint
End point values BNT162b2SA (30 mcg) Number of subjects analysed 324 Units: Percentage of subjects     number (confidence interval 95%) 1.2 (0.3 to 3.1)
No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: BNT162b2-Naïve Subjects who Were Enrolled to Receive BNT162b2SA Top of page

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Booster Dose: BNT162b2-Experienced Subjects Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose) Top of page
End point title	Percentage of Subjects With Local Reactions Within 7 Days After Booster Dose: BNT162b2-Experienced Subjects Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose) [51]
End point description	Local reactions included redness, swelling and, pain at the injection site, recorded by subjects in an 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 Booster Dose
Notes [51] - 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 was planned for this endpoint
End point values BNT162b2 5 mcg dose: 18-55 years of age BNT162b2 5 mcg: >55 years of age BNT162b2 10 mcg: 18-55 years of age BNT162b2 10 mcg: >55 years of age Number of subjects analysed 25 52 25 51 Units: Percentage of subjects number (confidence interval 95%)     Redness: Mild 0 (0.0 to 13.7) 0 (0.0 to 6.8) 0 (0.0 to 13.7) 0 (0.0 to 7.0)     Redness: Moderate 0 (0.0 to 13.7) 1.9 (0.0 to 10.3) 0 (0.0 to 13.7) 0 (0.0 to 7.0)     Redness: Severe 0 (0.0 to 13.7) 0 (0.0 to 6.8) 0 (0.0 to 13.7) 0 (0.0 to 7.0)     Redness: Grade 4 0 (0.0 to 13.7) 0 (0.0 to 6.8) 0 (0.0 to 13.7) 0 (0.0 to 7.0)     Swelling: Mild 0 (0.0 to 13.7) 1.9 (0.0 to 10.3) 0 (0.0 to 13.7) 3.9 (0.5 to 13.5)     Swelling: Moderate 0 (0.0 to 13.7) 0 (0.0 to 6.8) 0 (0.0 to 13.7) 2.0 (0.0 to 10.4)     Swelling: Severe 0 (0.0 to 13.7) 0 (0.0 to 6.8) 0 (0.0 to 13.7) 0 (0.0 to 7.0)     Swelling: Grade 4 0 (0.0 to 13.7) 0 (0.0 to 6.8) 0 (0.0 to 13.7) 0 (0.0 to 7.0)     Pain at injection site: Mild 56.0 (34.9 to 75.6) 34.6 (22.0 to 49.1) 48.0 (27.8 to 68.7) 66.7 (52.1 to 79.2)     Pain at injection site: Moderate 0 (0.0 to 13.7) 1.9 (0.0 to 10.3) 12.0 (2.5 to 31.2) 5.9 (1.2 to 16.2)     Pain at injection site: Severe 0 (0.0 to 13.7) 0 (0.0 to 6.8) 0 (0.0 to 13.7) 0 (0.0 to 7.0)     Pain at injection site: Grade 4 0 (0.0 to 13.7) 0 (0.0 to 6.8) 0 (0.0 to 13.7) 0 (0.0 to 7.0)
No statistical analyses for this end point

Primary: Percentage of Subjects With Local Reactions Within 7 Days After Booster Dose: BNT162b2-Experienced Subjects Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose) Top of page

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Booster Dose: BNT162b2-Experienced Subjects Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose) Top of page
End point title	Percentage of Subjects With Systemic Events Within 7 Days After Booster Dose: BNT162b2-Experienced Subjects Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose) [52]
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 deg C categorised as >=38.0 to 38.4, >38.4 to 38.9, >38.9 to 40.0 and >40.0 deg 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 (>2 times in 24 h), severe (requires IV hydration), Grade 4 (emergency room visit/hospitalisation for hypotensive shock). Diarrhea:mild (2-3 loose stools in 24h), moderate (4-5 loose stools in 24 h), severe (≥6 loose stools in 24 h) and Grade 4 (emergency room visit/hospitalisation). Number analyzed = Safety population with e-diary data after booster dose. HIV subjects were excluded.
End point type	Primary
End point timeframe	Within 7 Days After Booster Dose
Notes [52] - 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 was planned for this endpoint
End point values BNT162b2 5 mcg dose: 18-55 years of age BNT162b2 5 mcg: >55 years of age BNT162b2 10 mcg: 18-55 years of age BNT162b2 10 mcg: >55 years of age Number of subjects analysed 25 52 25 51 Units: Percenatge of subjects number (confidence interval 95%)     Fever: 38.0°C to 38.4°C 0 (0.0 to 13.7) 0 (0.0 to 6.8) 4.0 (0.1 to 20.4) 0 (0.0 to 7.0)     Fever: >38.4°C to 38.9°C 0 (0.0 to 13.7) 0 (0.0 to 6.8) 0 (0.0 to 13.7) 0 (0.0 to 7.0)     Fever: >38.9°C to 40.0°C 0 (0.0 to 13.7) 0 (0.0 to 6.8) 0 (0.0 to 13.7) 2.0 (0.0 to 10.4)     Fever: >40.0°C 0 (0.0 to 13.7) 0 (0.0 to 6.8) 0 (0.0 to 13.7) 0 (0.0 to 7.0)     Fatigue: Mild 20.0 (6.8 to 40.7) 15.4 (6.9 to 28.1) 32.0 (14.9 to 53.5) 29.4 (17.5 to 43.8)     Fatigue: Moderate 24.0 (9.4 to 45.1) 9.6 (3.2 to 21.0) 24.0 (9.4 to 45.1) 19.6 (9.8 to 33.1)     Fatigue: Severe 0 (0.0 to 13.7) 1.9 (0.0 to 10.3) 4.0 (0.1 to 20.4) 2.0 (0.0 to 10.4)     Fatigue: Grade 4 0 (0.0 to 13.7) 0 (0.0 to 6.8) 0 (0.0 to 13.7) 0 (0.0 to 7.0)     Headache: Mild 20.0 (6.8 to 40.7) 15.4 (6.9 to 28.1) 20.0 (6.8 to 40.7) 23.5 (12.8 to 37.5)     Headache: Moderate 4.0 (0.1 to 20.4) 7.7 (2.1 to 18.5) 16.0 (4.5 to 36.1) 13.7 (5.7 to 26.3)     Headache: Severe 0 (0.0 to 13.7) 0 (0.0 to 6.8) 4.0 (0.1 to 20.4) 0 (0.0 to 7.0)     Headache: Grade 4 0 (0.0 to 13.7) 0 (0.0 to 6.8) 0 (0.0 to 13.7) 0 (0.0 to 7.0)     Chills: Mild 8.0 (1.0 to 26.0) 9.6 (3.2 to 21.0) 12.0 (2.5 to 31.2) 13.7 (5.7 to 26.3)     Chills: Moderate 0 (0.0 to 13.7) 1.9 (0.0 to 10.3) 12.0 (2.5 to 31.2) 7.8 (2.2 to 18.9)     Chills: Severe 0 (0.0 to 13.7) 0 (0.0 to 6.8) 0 (0.0 to 13.7) 0 (0.0 to 7.0)     Chills: Grade 4 0 (0.0 to 13.7) 0 (0.0 to 6.8) 0 (0.0 to 13.7) 0 (0.0 to 7.0)     Vomiting: Mild 0 (0.0 to 13.7) 0 (0.0 to 6.8) 0 (0.0 to 13.7) 0 (0.0 to 7.0)     Vomiting: Moderate 0 (0.0 to 13.7) 3.8 (0.5 to 13.2) 0 (0.0 to 13.7) 0 (0.0 to 7.0)     Vomiting: Severe 0 (0.0 to 13.7) 0 (0.0 to 6.8) 0 (0.0 to 13.7) 0 (0.0 to 7.0)     Vomiting: Grade 4 0 (0.0 to 13.7) 0 (0.0 to 6.8) 0 (0.0 to 13.7) 0 (0.0 to 7.0)     Diarrhea: Mild 8.0 (1.0 to 26.0) 0 (0.0 to 6.8) 16.0 (4.5 to 36.1) 2.0 (0.0 to 10.4)     Diarrhea: Moderate 0 (0.0 to 13.7) 3.8 (0.5 to 13.2) 0 (0.0 to 13.7) 0 (0.0 to 7.0)     Diarrhea: Severe 0 (0.0 to 13.7) 0 (0.0 to 6.8) 0 (0.0 to 13.7) 0 (0.0 to 7.0)     Diarrhea: Grade 4 0 (0.0 to 13.7) 0 (0.0 to 6.8) 0 (0.0 to 13.7) 0 (0.0 to 7.0)     New or worsened muscle pain: Mild 24.0 (9.4 to 45.1) 11.5 (4.4 to 23.4) 16.0 (4.5 to 36.1) 5.9 (1.2 to 16.2)     New or worsened muscle pain: Moderate 0 (0.0 to 13.7) 1.9 (0.0 to 10.3) 12.0 (2.5 to 31.2) 7.8 (2.2 to 18.9)     New or worsened muscle pain: Severe 0 (0.0 to 13.7) 0 (0.0 to 6.8) 0 (0.0 to 13.7) 0 (0.0 to 7.0)     New or worsened muscle pain: Grade 4 0.0 (0.0 to 13.7) 0 (0.0 to 6.8) 0 (0.0 to 13.7) 0 (0.0 to 7.0)     New or worsened joint pain: Mild 4.0 (0.1 to 20.4) 0 (0.0 to 6.8) 8.0 (1.0 to 26.0) 7.8 (2.2 to 18.9)     New or worsened joint pain: Moderate 0 (0.0 to 13.7) 0 (0.0 to 6.8) 12.0 (2.5 to 31.2) 5.9 (1.2 to 16.2)     New or worsened joint pain: Severe 0 (0.0 to 13.7) 0 (0.0 to 6.8) 0 (0.0 to 13.7) 0 (0.0 to 7.0)     New or worsened joint pain: Grade 4 0 (0.0 to 13.7) 0 (0.0 to 6.8) 0 (0.0 to 13.7) 0 (0.0 to 7.0)
No statistical analyses for this end point

Primary: Percentage of Subjects With Systemic Events Within 7 Days After Booster Dose: BNT162b2-Experienced Subjects Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose) Top of page

Primary: Percentage of Subjects Reporting Adverse Events From Booster Dose to 1 Month After Booster Dose: BNT162b2-Experienced Subjects Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose) Top of page
End point title	Percentage of Subjects Reporting Adverse Events From Booster Dose to 1 Month After Booster Dose: BNT162b2-Experienced Subjects Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose) [53]
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. HIV participants were excluded.
End point type	Primary
End point timeframe	From Booster Dose to 1 Months After Booster Dose
Notes [53] - 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 was planned for this endpoint
End point values BNT162b2 5 mcg dose: 18-55 years of age BNT162b2 5 mcg: >55 years of age BNT162b2 10 mcg: 18-55 years of age BNT162b2 10 mcg: >55 years of age Number of subjects analysed 26 53 25 51 Units: Percentage of subjects     number (confidence interval 95%) 11.5 (2.4 to 30.2) 3.8 (0.5 to 13.0) 8.0 (1.0 to 26.0) 0.0 (0.0 to 7.0)
No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Adverse Events From Booster Dose to 1 Month After Booster Dose: BNT162b2-Experienced Subjects Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose) Top of page

Primary: Percentage of Subjects Reporting Serious Adverse Events From Booster Dose to 6 Months After Booster Dose: BNT162b2-Experienced Subjects Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose) Top of page
End point title	Percentage of Subjects Reporting Serious Adverse Events From Booster Dose to 6 Months After Booster Dose: BNT162b2-Experienced Subjects Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose) [54]
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. HIV positive subjects were excluded.
End point type	Primary
End point timeframe	From Booster Dose to 6 Months After Booster Dose
Notes [54] - 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 was planned for this endpoint
End point values BNT162b2 5 mcg dose: 18-55 years of age BNT162b2 5 mcg: >55 years of age BNT162b2 10 mcg: 18-55 years of age BNT162b2 10 mcg: >55 years of age Number of subjects analysed 26 53 25 51 Units: Percentage of subjects     number (confidence interval 95%) 0 (0.0 to 13.2) 1.9 (0.0 to 10.1) 0 (0.0 to 13.7) 0 (0.0 to 7.0)
No statistical analyses for this end point

Primary: Percentage of Subjects Reporting Serious Adverse Events From Booster Dose to 6 Months After Booster Dose: BNT162b2-Experienced Subjects Who Were Rerandomized to Receive 1 Booster Dose of BNT162b2 (Lower Dose) Top of page

Primary: COVID-19 Incidence Per 1000 Person-Years of Follow-up Based on Central Laboratory or Locally Confirmed Nucleic Acid Amplification Test (NAAT) in Subjects Without Serological or Virological Evidence: Phase 2/3 Top of page
End point title	COVID-19 Incidence Per 1000 Person-Years of Follow-up Based on Central Laboratory or Locally Confirmed Nucleic Acid Amplification Test (NAAT) in Subjects Without Serological or Virological Evidence: Phase 2/3
End point description	Occurrences of first COVID-19 infection in subjects followed up based on central laboratory or locally confirmed NAAT in subjects, without serological or virological evidence of prior SARS-CoV-2 infection were reported in this endpoint. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint. Evaluable efficacy:eligible randomized subjects who receive all vaccination(s) as randomized, with Dose 2 received within the predefined window (within 19-42 days after Dose 1) and have no other important protocol deviations were determined by the clinician on or before 7 days after Dose 2. HIV positive subjects were excluded from this analysis.
End point type	Primary
End point timeframe	From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 6.247, Placebo - 6.003)
End point values BNT162b2 (30 mcg) Placebo Number of subjects analysed 20712 20713 Units: Number of cases     number (not applicable) 77 850
Statistical analysis title	BNT162b2 30 mcg versus Placebo
Statistical analysis description	Confidence interval (CI) for VE is derived based on the Clopper and Pearson method adjusted for surveillance time.
Comparison groups	BNT162b2 (30 mcg) v Placebo
Number of subjects included in analysis	41425
Analysis specification	Pre-specified
Analysis type	superiority
Method
Parameter type	Vaccine efficacy
Point estimate	91.3
Confidence interval
level	95%
sides	2-sided
lower limit	89
upper limit	93.2

Primary: COVID-19 Incidence Per 1000 Person-Years of Follow-up Based on Central Laboratory or Locally Confirmed Nucleic Acid Amplification Test (NAAT) in Subjects Without Serological or Virological Evidence: Phase 2/3 Top of page

Primary: COVID-19 Incidence Per 1000 Person-Years of Follow-up Based on Central Laboratory or Locally Confirmed Nucleic Acid Amplification Test (NAAT) in Subjects Without Serological or Virological Evidence: Phase 2/3 (Analysis for EUA) Top of page
End point title	COVID-19 Incidence Per 1000 Person-Years of Follow-up Based on Central Laboratory or Locally Confirmed Nucleic Acid Amplification Test (NAAT) in Subjects Without Serological or Virological Evidence: Phase 2/3 (Analysis for EUA)
End point description	Occurrences of first COVID-19 infection in subjects followed up based on central laboratory or locally confirmed NAAT in subjects, without serological or virological evidence of prior SARS-CoV-2 were reported in this endpoint. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint. Evaluable efficacy:eligible randomized subjects who receive all vaccination(s) as randomized, with Dose 2 received within the predefined window (within 19-42 days after Dose 1) and have no other important protocol deviations were determined by the clinician on or before 7 days after Dose 2. HIV positive subjects were excluded from this analysis.
End point type	Primary
End point timeframe	From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 2.214, Placebo - 2.222)
End point values BNT162b2 (30 mcg) Placebo Number of subjects analysed 17411 17511 Units: Cases     number (not applicable) 8 162
Statistical analysis title	BNT162b2 30mcg versus Placebo
Statistical analysis description	Total surveillance time in 1000 person-years for the given endpoint across all subjects within each group at risk for the endpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
Comparison groups	BNT162b2 (30 mcg) v Placebo
Number of subjects included in analysis	34922
Analysis specification	Pre-specified
Analysis type	superiority [55]
Method
Parameter type	Beta binomial model
Point estimate	95
Confidence interval
level	95%
sides	2-sided
lower limit	90.3
upper limit	97.6
Notes [55] - Credible interval calculated using beta-binomial model with prior beta (0.700102, 1) adjusted for surveillance time.

Primary: COVID-19 Incidence Per 1000 Person-Years of Follow-up Based on Central Laboratory or Locally Confirmed Nucleic Acid Amplification Test (NAAT) in Subjects Without Serological or Virological Evidence: Phase 2/3 (Analysis for EUA) Top of page

Primary: COVID-19 Incidence Per 1000 Person-Years of Follow-up Based on Central Laboratory or Locally Confirmed Nucleic Acid Amplification Test (NAAT) in Subjects With or Without Serological or Virological Evidence: Phase 2/3 Top of page
End point title	COVID-19 Incidence Per 1000 Person-Years of Follow-up Based on Central Laboratory or Locally Confirmed Nucleic Acid Amplification Test (NAAT) in Subjects With or Without Serological or Virological Evidence: Phase 2/3
End point description	Occurrences of first COVID-19 infection in subjects followed up based on central laboratory or locally confirmed NAAT in subjects, with or without serological or virological evidence of prior SARS-CoV-2 infection were reported in this endpoint. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint. Evaluable efficacy:eligible randomized subjects who receive all vaccination(s) as randomized, with Dose 2 received within the predefined window (within 19-42 days after Dose 1) and have no other important protocol deviations were determined by the clinician on or before 7 days after Dose 2. HIV positive subjects were excluded from this analysis.
End point type	Primary
End point timeframe	From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 6.509, Placebo - 6.003)
End point values BNT162b2 (30 mcg) Placebo Number of subjects analysed 21642 21689 Units: Number of cases     number (not applicable) 81 873
Statistical analysis title	BNT162b2 30 mcg versus Placebo
Statistical analysis description	Confidence interval (CI) for VE is derived based on the Clopper and Pearson method adjusted for surveillance time.
Comparison groups	BNT162b2 (30 mcg) v Placebo
Number of subjects included in analysis	43331
Analysis specification	Pre-specified
Analysis type	superiority
Method
Parameter type	Vaccine efficacy (VE)
Point estimate	91.1
Confidence interval
level	95%
sides	2-sided
lower limit	88.8
upper limit	93

Primary: COVID-19 Incidence Per 1000 Person-Years of Follow-up Based on Central Laboratory or Locally Confirmed Nucleic Acid Amplification Test (NAAT) in Subjects With or Without Serological or Virological Evidence: Phase 2/3 Top of page

Primary: COVID-19 Incidence Per 1000 Person-Years of Follow-up Based on Central Laboratory or Locally Confirmed Nucleic Acid Amplification Test (NAAT) in Subjects With or Without Serological or Virological Evidence: Phase 2/3 (Analysis for EUA) Top of page
End point title	COVID-19 Incidence Per 1000 Person-Years of Follow-up Based on Central Laboratory or Locally Confirmed Nucleic Acid Amplification Test (NAAT) in Subjects With or Without Serological or Virological Evidence: Phase 2/3 (Analysis for EUA)
End point description	Occurrences of first COVID-19 infection in subjects followed up based on central laboratory or locally confirmed NAAT in subjects with or without serological or virological evidence of prior SARS-CoV-2 infection were reported in this endpoint. Here, 'Number of Subjects Analysed' signifies subjects evaluable for this endpoint. Evaluable efficacy:eligible randomized subjects who receive all vaccination(s) as randomized, with Dose 2 received within the predefined window (within 19-42 days after Dose 1) and have no other important protocol deviations were determined by the clinician on or before 7 days after Dose 2. HIV positive subjects were excluded from this analysis.
End point type	Primary
End point timeframe	From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 – 2.332, Placebo – 2.345)
End point values BNT162b2 (30 mcg) Placebo Number of subjects analysed 18559 18708 Units: Cases     number (not applicable) 9 169
Statistical analysis title	BNT162b2 (30 mcg) versus Placebo
Statistical analysis description	Total surveillance time in 1000 person-years for the given endpoint across all subjects within each group at risk for the endpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
Comparison groups	BNT162b2 (30 mcg) v Placebo
Number of subjects included in analysis	37267
Analysis specification	Pre-specified
Analysis type	superiority [56]
Method
Parameter type	Beta binomial model
Point estimate	94.6
Confidence interval
level	95%
sides	2-sided
lower limit	89.9
upper limit	97.3
Notes [56] - Credible interval calculated using beta-binomial model with prior beta (0.700102, 1) adjusted for surveillance time.

Primary: COVID-19 Incidence Per 1000 Person-Years of Follow-up Based on Central Laboratory or Locally Confirmed Nucleic Acid Amplification Test (NAAT) in Subjects With or Without Serological or Virological Evidence: Phase 2/3 (Analysis for EUA) Top of page

Primary: Percentage Difference of Subjects Achieving Seroresponse Comparison (N1b) of 1 Month After Dose 2 Between Vaccine Groups: BNT162b2-Naïve Subjects Without Evidence of Infection up to 1 Month After Dose 2: Phase 3 Top of page
End point title	Percentage Difference of Subjects Achieving Seroresponse Comparison (N1b) of 1 Month After Dose 2 Between Vaccine Groups: BNT162b2-Naïve Subjects Without Evidence of Infection up to 1 Month After Dose 2: Phase 3
End point description	Seroresponse was defined as achieving a >=4-fold rise from baseline (before Dose 1). If the baseline measurement was below the LLOQ, a postvaccination assay result ≥4 × LLOQ is considered a seroresponse. Sequential tests conducted was N1b. 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), had 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.
End point type	Primary
End point timeframe	1 Month After Dose 2
End point values BNT162b2SA (30 mcg) BNT162b2 (30 mcg) Number of subjects analysed 272 304 Units: Percentage difference     number (confidence interval 97.5%) 97.1 (94.3 to 98.7) 97.3 (94.6 to 98.9)
Statistical analysis title	BNT162b2SA (30 mcg) vs BNT162b2 (30 mcg)
Statistical analysis description	Noninferiority of N1b is declared if the lower bound of the 2-sided 97.5% CI for the percentage difference is greater than -10%.
Comparison groups	BNT162b2SA (30 mcg) v BNT162b2 (30 mcg)
Number of subjects included in analysis	576
Analysis specification	Pre-specified
Analysis type	non-inferiority [57]
Method
Parameter type	Percentage difference
Point estimate	-0.3
Confidence interval
level	97.5%
sides	2-sided
lower limit	-3.9
upper limit	3.4
Notes [57] - Analysis was done for BNT162b2SA (30 mcg):SA variant vs BNT162b2 (30 mcg): Ref strain

Primary: Percentage Difference of Subjects Achieving Seroresponse Comparison (N1b) of 1 Month After Dose 2 Between Vaccine Groups: BNT162b2-Naïve Subjects Without Evidence of Infection up to 1 Month After Dose 2: Phase 3 Top of page

Primary: GMR based on Geometric Mean Titer - Comparison of 1 Month After Dose 2 Between Vaccine Groups: BNT162b2-Naïve Subjects Without Evidence of Infection (N1a) up to 1 Month After Dose 2: Phase 3 Top of page
End point title	GMR based on Geometric Mean Titer - Comparison of 1 Month After Dose 2 Between Vaccine Groups: BNT162b2-Naïve Subjects Without Evidence of Infection (N1a) up to 1 Month After Dose 2: Phase 3
End point description	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), had 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.
End point type	Primary
End point timeframe	1 Month After Dose 2
End point values BNT162b2SA (30 mcg) BNT162b2 (30 mcg) Number of subjects analysed 272 284 Units: Titer     number (confidence interval 95%) 1358.0 (1242.2 to 1484.5) 820.3 (745.7 to 902.3)
Statistical analysis title	BNT162b2SA:SA variant vs BNT162b2:Reference Strain
Statistical analysis description	Noninferiority of N1a is declared if the lower bound of the 2-sided 97.5% CI for the GMR is greater than 0.67 and the point estimate of the GMR is >=0.8.
Comparison groups	BNT162b2SA (30 mcg) v BNT162b2 (30 mcg)
Number of subjects included in analysis	556
Analysis specification	Pre-specified
Analysis type	non-inferiority [58]
Method
Parameter type	Geometric Mean Ratio
Point estimate	1.66
Confidence interval
level	97.5%
sides	2-sided
lower limit	1.43
upper limit	1.92
Notes [58] - Analysis was done for BNT162b2SA (30 mcg):SA variant vs BNT162b2 (30 mcg): Ref strain

Primary: GMR based on Geometric Mean Titer - Comparison of 1 Month After Dose 2 Between Vaccine Groups: BNT162b2-Naïve Subjects Without Evidence of Infection (N1a) up to 1 Month After Dose 2: Phase 3 Top of page

Primary: GMR of Neutralizing Titers(E1a) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Subjects That Received a Booster Dose of BNT162b2: Phase 3 Top of page
End point title	GMR of Neutralizing Titers(E1a) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Subjects That Received a Booster Dose of BNT162b2: Phase 3
End point description	Dose 3 booster evaluable immunogenicity population included all eligible randomised subjects who received 2 doses of BNT162b2 (or BNT162b1 for Phase 1) as initially randomised, with Dose 2 received within the predefined window (within 19-42 days after Dose 1), receive a third dose of BNT162b2 or BNT162b2SA as rerandomized (or receive a third dose of BNT162b2 for Phase 1), have at least 1 valid and determinate immunogenicity result after Dose 3 from a blood collection within an appropriate window (within 28-42 days after Dose 3), and had no other important protocol deviations as determined by the clinician. HIV positive subjects were excluded from this analysis.
End point type	Primary
End point timeframe	1 Month After Booster Dose to 1 Month After Dose 2
End point values BNT162b2 (30 mcg): 1 Month After Booster Dose BNT162b2 (30 mcg): 1 Month After Dose 2 Number of subjects analysed 212 212 Units: Titer     number (confidence interval 95%) 2466.0 (2202.6 to 2760.8) 755.7 (663.1 to 861.2)
Statistical analysis title	BNT162b2SA:Ref strain vs BNT162b2:Ref Strain
Statistical analysis description	Noninferiority is declared if the lower bound of the 2-sided 97.5% CI for the GMR is greater than 0.67 and the point estimate of the GMR is >=0.8, if the previous objectives in the testing sequence are established.
Comparison groups	BNT162b2 (30 mcg): 1 Month After Booster Dose v BNT162b2 (30 mcg): 1 Month After Dose 2
Number of subjects included in analysis	424
Analysis specification	Pre-specified
Analysis type	non-inferiority [59]
Method
Parameter type	Geometric Mean Ratio
Point estimate	3.26
Confidence interval
level	95%
sides	2-sided
lower limit	2.76
upper limit	3.86
Notes [59] - While there are 424 data points (2 per subject) the number of subjects in this analysis was only 212.

Primary: GMR of Neutralizing Titers(E1a) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Subjects That Received a Booster Dose of BNT162b2: Phase 3 Top of page

Primary: GMR of Neutralising Titers (E2a) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Subjects: Phase 3 Top of page
End point title	GMR of Neutralising Titers (E2a) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Subjects: Phase 3
End point description	Dose 3 booster evaluable immunogenicity population included all eligible randomised subjects who received 2 doses of BNT162b2 (or BNT162b1 for Phase 1) as initially randomised, with Dose 2 received within the predefined window (within 19-42 days after Dose 1), receive a third dose of BNT162b2 or BNT162b2SA as rerandomized (or receive a third dose of BNT162b2 for Phase 1), have at least 1 valid and determinate immunogenicity result after Dose 3 from a blood collection within an appropriate window (within 28-42 days after Dose 3), and had no other important protocol deviations as determined by the clinician. HIV positive subjects were excluded from this analysis.
End point type	Primary
End point timeframe	1 Month After Booster Dose to 1 Month After Dose 2
End point values BNT162b2SA (30 mcg):1 Month After Booster Dose BNT162b2SA 30 mcg: 1 Month After Dose 2 Number of subjects analysed 242 242 Units: Titer     number (confidence interval 95%) 3580.5 (3146.6 to 4074.3) 688.3 (616.1 to 768.8)
Statistical analysis title	BNT162b2SA:SA variant vs BNT162b2:Ref Strain
Statistical analysis description	E2a:Noninferiority is declared if the lower bound of the 2-sided 97.5% CI for the GMR is greater than 0.67 and the point estimate of the GMR is ≥0.8, if the previous objectives in the testing sequence are established.
Comparison groups	BNT162b2SA (30 mcg):1 Month After Booster Dose v BNT162b2SA 30 mcg: 1 Month After Dose 2
Number of subjects included in analysis	484
Analysis specification	Pre-specified
Analysis type	non-inferiority [60]
Method
Parameter type	Geometric Mean Ratio
Point estimate	5.2
Confidence interval
level	95%
sides	2-sided
lower limit	4.5
upper limit	6.01
Notes [60] - While there are 484 data points (2 per subject) the number of subjects in this analysis was only 242.

Primary: GMR of Neutralising Titers (E2a) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Subjects: Phase 3 Top of page

Primary: Percentage Difference of Subjects Achieving Seroresponse (E1b) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Subjects That Received a Booster Dose of BNT162b2: Phase 3 Top of page
End point title	Percentage Difference of Subjects Achieving Seroresponse (E1b) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Subjects That Received a Booster Dose of BNT162b2: Phase 3
End point description	Percentage difference of subjects achieving seroresponse – comparison of 1 month after booster dose to 1 month after dose 2 BNT162b2-experienced subjects without evidence of infection up to 1 month after booster dose who were rerandomized to receive 1 booster dose were reported in this endpoint. Dose 3 booster evaluable immunogenicity population included all eligible randomised subjects who received 2 doses of BNT162b2 (or BNT162b1 for Phase 1) as initially randomised, with Dose 2 received within the predefined window (within 19-42 days after Dose 1), receive a third dose of BNT162b2 or BNT162b2SA as rerandomized (or receive a third dose of BNT162b2 for Phase 1), have at least 1 valid and determinate immunogenicity result after Dose 3 from a blood collection within an appropriate window (within 28-42 days after Dose 3), and had no other important protocol deviations as determined by the clinician. HIV positive subjects were excluded from this analysis.
End point type	Primary
End point timeframe	1 Month After Booster Dose to 1 Month After Dose 2
End point values BNT162b2 (30 mcg): 1 Month After Booster Dose BNT162b2 (30 mcg): 1 Month After Dose 2 Number of subjects analysed 200 200 Units: Percentage difference     number (confidence interval 95%) 99.5 (97.2 to 100.0) 95.0 (91.0 to 97.6)
Statistical analysis title	BNT162b2 PD3 ref vs BNT162b2 PD2 ref
Statistical analysis description	E1b: Noninferiority is declared if the lower bound of the 2-sided 97.5% CI for the percentage difference is greater than -10, if the previous objectives in testing sequence are established.
Comparison groups	BNT162b2 (30 mcg): 1 Month After Booster Dose v BNT162b2 (30 mcg): 1 Month After Dose 2
Number of subjects included in analysis	400
Analysis specification	Pre-specified
Analysis type	non-inferiority [61]
Method
Parameter type	Percentage difference
Point estimate	4.5
Confidence interval
level	97.5%
sides	2-sided
lower limit	1
upper limit	7.9
Notes [61] - While there are 400 data points (2 per subject) the number of subjects in this analysis was only 200.

Primary: Percentage Difference of Subjects Achieving Seroresponse (E1b) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Subjects That Received a Booster Dose of BNT162b2: Phase 3 Top of page

Primary: Percentage Difference of Subjects Achieving Seroresponse (E2b) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Subjects: Phase 3 Top of page
End point title	Percentage Difference of Subjects Achieving Seroresponse (E2b) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Subjects: Phase 3
End point description	Percentage difference of subjects achieving seroresponse – comparison of 1 month after booster dose to 1 month after dose 2 BNT162b2-experienced subjects without evidence of infection up to 1 month after booster dose who were rerandomized to receive 1 booster dose were reported in this endpoint. Dose 3 evaluable immunogenicity population included all eligible randomised subjects who received 2 doses of BNT162b2 (or BNT162b1 for Phase 1) as initially randomised, with Dose 2 received within the predefined window (within 19-42 days after Dose 1), receive a third dose of BNT162b2 or BNT162b2SA as rerandomized (or received a third dose of BNT162b2 for Phase 1), had at least 1 valid and determinate immunogenicity result after Dose 3 from a blood collection within an appropriate window (within 28-42 days after Dose 3), and had no other important protocol deviations as determined by the clinician.
End point type	Primary
End point timeframe	1 Month After Booster Dose to 1 Month After Dose 2
End point values BNT162b2SA (30 mcg): 1 Month After Booster Dose BNT162b2SA 30 mcg: 1 Month After Dose 2 Number of subjects analysed 221 221 Units: Percentage of subjects     number (confidence interval 95%) 99.1 (96.8 to 99.9) 94.1 (90.2 to 96.8)
Statistical analysis title	BNT162b2SA:SA variant vs BNT162b2:Ref Strain
Statistical analysis description	E2b: Noninferiority is declared if the lower bound of the 2-sided 97.5% CI for the percentage difference is greater than -10, if the previous objectives in testing sequence are established.
Comparison groups	BNT162b2SA (30 mcg): 1 Month After Booster Dose v BNT162b2SA 30 mcg: 1 Month After Dose 2
Number of subjects included in analysis	442
Analysis specification	Pre-specified
Analysis type	non-inferiority [62]
Method
Parameter type	Percentage difference
Point estimate	5
Confidence interval
level	97.5%
sides	2-sided
lower limit	1
upper limit	8.9
Notes [62] - While there are 442 data points (2 per subject) the number of subjects in this analysis was only 221.

Primary: Percentage Difference of Subjects Achieving Seroresponse (E2b) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Subjects: Phase 3 Top of page

Secondary: Geometric Mean Titers (GMTs) of Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Titers: Phase 1 Top of page
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 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 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) 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) 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) 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) 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) 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) 0.0 (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)     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)     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) 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) 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) 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)
No statistical analyses for this end point

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

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

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

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

Secondary: Percentage of Subjects Achieving a >= 4-Fold Rise From Before Vaccination to After Vaccination: Neutralising Titers: Phase 1 Top of page
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 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 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) 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 (0.0 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 (-99999 to 99999) 0 (-99999 to 99999) 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) 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 (-99999 to 99999) 0 (-99999 to 99999) 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) 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 (-99999 to 99999) 0 (-99999 to 99999) 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) 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 (-99999 to 99999) 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) 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 (-99999 to 99999) 0 (-99999 to 99999) 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 (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 (-99999 to 99999) 0 (-99999 to 99999) 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 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 (-99999 to 99999) 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) 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 (-99999 to 99999) 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) 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 (-99999 to 99999) 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) 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 (-99999 to 99999) 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: Neutralising Titers: Phase 1 Top of page

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 Top of page
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 (-99999 to 99999) 0.0 (-99999 to 99999) 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 (-99999 to 0.0) 0.0 (-99999 to 99999) 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 (-99999 to 0.0) 0.0 (-99999 to 99999) 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 (-99999 to 0.0) 0.0 (-99999 to 99999) 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 (-99999 to 99999) 0 (-99999 to 99999) 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 (-99999 to 99999) 0 (-99999 to 99999) 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 (-99999 to 99999) 0 (-99999 to 99999) 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 (-99999 to 99999) 0 (-99999 to 99999) 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 Top of page

Secondary: GMR Based on Reference Strain NT - Comparison of Subjects 12 to 15 Years of Age to Subjects 16 to 25 Years of Age- Subjects Without Evidence of Infection up to 1 Month After Dose 2 - Dose 2 Evaluable Immunogenicity Population: Phase2/3 Top of page
End point title	GMR Based on Reference Strain NT - Comparison of Subjects 12 to 15 Years of Age to Subjects 16 to 25 Years of Age- 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 reference strain NT - 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
Statistical analysis description	Noninferiority is declared if the lower bound of the 2-sided 95% CI for the GMR is greater than 0.67
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

Secondary: GMR Based on Reference Strain NT - Comparison of Subjects 12 to 15 Years of Age to Subjects 16 to 25 Years of Age- Subjects Without Evidence of Infection up to 1 Month After Dose 2 - Dose 2 Evaluable Immunogenicity Population: Phase2/3 Top of page

Secondary: Incidence of Asymptomatic SARS-CoV-2 Infection per 1000 Person Years Follow-up Without Serological or Virological Evidence (Up to Start of Asymptomatic Surveillance Period) of Past Infection: Phase 3 Top of page
End point title	Incidence of Asymptomatic SARS-CoV-2 Infection per 1000 Person Years Follow-up Without Serological or Virological Evidence (Up to Start of Asymptomatic Surveillance Period) of Past Infection: Phase 3
End point description	Incidence of asymptomatic SARS-CoV-2 infection per 1000 person years follow-up without serological or virological evidence (up to start of asymptomatic surveillance period) of past infection were reported in this endpoint. Evaluable efficacy (asymptomatic surveillance) included all eligible randomised subjects who received all vaccination(s) as randomized, with Dose 2 received within the predefined window (within 19-42 days after Dose 1), consented to participate in the asymptomatic surveillance, and had no other important protocol deviations as determined by the clinician on or before the start of the asymptomatic surveillance period. HIV positive subjects were excluded from this analysis.
End point type	Secondary
End point timeframe	From start of asymptomatic surveillance (Surveillance time [1000 person-years]: BNT162b2 – 0.383; Placebo – 0.200
End point values BNT162b2 (30 mcg) Placebo Number of subjects analysed 2092 1829 Units: Cases     number (not applicable) 24 20
Statistical analysis title	BNT162b2 (30 mcg) versus Placebo
Statistical analysis description	Two-sided confidence interval (CI) for VE is derived based on the Clopper and Pearson method adjusted for surveillance time.
Comparison groups	BNT162b2 (30 mcg) v Placebo
Number of subjects included in analysis	3921
Analysis specification	Pre-specified
Analysis type	superiority
Method
Parameter type	Vaccine efficacy
Point estimate	37.2
Confidence interval
level	95%
sides	2-sided
lower limit	-20
upper limit	66.7

Secondary: Incidence of Asymptomatic SARS-CoV-2 Infection per 1000 Person Years Follow-up Without Serological or Virological Evidence (Up to Start of Asymptomatic Surveillance Period) of Past Infection: Phase 3 Top of page

Secondary: Incidence of Asymptomatic SARS-CoV-2 Infection per 1000 Person Years Follow-up Without Serological or Virological Evidence of Past Infection Based on N-binding Antibody Seroconversion: Phase 3 Top of page
End point title	Incidence of Asymptomatic SARS-CoV-2 Infection per 1000 Person Years Follow-up Without Serological or Virological Evidence of Past Infection Based on N-binding Antibody Seroconversion: Phase 3
End point description	Incidence of asymptomatic SARS-CoV-2 infection per 1000 person years follow-up without serological or virological evidence of past infection based on N-binding antibody seroconversion were reported in this endpoint. Evaluable efficacy (seroconversion) included all eligible randomised subjects who received all vaccination(s) as randomised, with Dose 2 received within the predefined window (within 19-42 days after Dose 1), had at least 1 N-binding antibody test result available at a post–Dose 2 visit, and had no other important protocol deviations as determined by the clinician prior to the first post–Dose 2 N-binding antibody test. HIV positive subjects were excluded from this analysis.
End point type	Secondary
End point timeframe	From Dose 2 to the end of the surveillance period ([1000 person-years]: BNT162b2 - 13.840, Placebo - 6.481)
End point values BNT162b2 (30 mcg) Placebo Number of subjects analysed 20872 20692 Units: Cases     number (not applicable) 612 608
Statistical analysis title	BNT162b2 30 μg versus Placebo
Statistical analysis description	Two-sided confidence interval (CI) for VE is derived based on the Clopper and Pearson method adjusted for surveillance time.
Comparison groups	BNT162b2 (30 mcg) v Placebo
Number of subjects included in analysis	41564
Analysis specification	Pre-specified
Analysis type	superiority
Method
Parameter type	Vaccine efficacy (VE)
Point estimate	52.9
Confidence interval
level	95%
sides	2-sided
lower limit	47.2
upper limit	57.9

Secondary: Incidence of Asymptomatic SARS-CoV-2 Infection per 1000 Person Years Follow-up Without Serological or Virological Evidence of Past Infection Based on N-binding Antibody Seroconversion: Phase 3 Top of page

Secondary: COVID-19 Incidence per 1000 Person-Years of Follow-up With or Without Evidence of Infection 14 Days After Second Dose of BNT162b2 Based on CDC-Defined Symptoms (Analysis for EUA): Phase 3 Top of page
End point title	COVID-19 Incidence per 1000 Person-Years of Follow-up With or Without Evidence of Infection 14 Days After Second Dose of BNT162b2 Based on CDC-Defined Symptoms (Analysis for EUA): Phase 3
End point description	COVID-19 incidence per 1000 person years follow-up with or without the evidence of infection were reported in this endpoint. Evaluable efficacy population included all eligible randomised subjects who received all vaccination(s) as randomized, with Dose 2 received within the predefined window (within 19-42 days after Dose 1) and have no other important protocol deviations as determined by the clinician on or before 14 days after Dose 2. HIV positive subjects were excluded from this analysis.
End point type	Secondary
End point timeframe	From 14 Days After Dose 2 (Surveillance time [1000 person-years]: BNT162b2 – 1.983, Placebo – 1.993)
End point values BNT162b2 (30 mcg) Placebo Number of subjects analysed 17630 17727 Units: Cases     number (not applicable) 8 146
Statistical analysis title	BNT162b2 30 mcg versus Placebo
Statistical analysis description	Confidence interval (CI) for VE is derived based on the Clopper and Pearson method adjusted for surveillance time.
Comparison groups	BNT162b2 (30 mcg) v Placebo
Number of subjects included in analysis	35357
Analysis specification	Pre-specified
Analysis type	superiority
Method
Parameter type	Vaccine efficacy
Point estimate	94.5
Confidence interval
level	95%
sides	2-sided
lower limit	88.9
upper limit	97.7

Secondary: COVID-19 Incidence per 1000 Person-Years of Follow-up With or Without Evidence of Infection 14 Days After Second Dose of BNT162b2 Based on CDC-Defined Symptoms (Analysis for EUA): Phase 3 Top of page

Secondary: COVID-19 Incidence per 1000 Person-Years of Follow-up With or Without Evidence of Infection 7 Days After Second Dose of BNT162b2 Based on CDC-Defined Symptoms (Analysis for EUA): Phase 3 Top of page
End point title	COVID-19 Incidence per 1000 Person-Years of Follow-up With or Without Evidence of Infection 7 Days After Second Dose of BNT162b2 Based on CDC-Defined Symptoms (Analysis for EUA): Phase 3
End point description	COVID-19 incidence per 1000 person years follow-up with or without the evidence of infection were reported in this endpoint. Evaluable efficacy population included all eligible randomised subjects who received all vaccination(s) as randomized, with Dose 2 received within the predefined window (within 19-42 days after Dose 1) and have no other important protocol deviations as determined by the clinician on or before 7 days after Dose 2. HIV positive subjects were excluded from this analysis.
End point type	Secondary
End point timeframe	From 7 Days After Dose 2 (Surveillance time [1000 person-years]: BNT162b2 – 2.330, Placebo – 2.343)
End point values BNT162b2 (30 mcg) Placebo Number of subjects analysed 18544 18690 Units: Cases     number (not applicable) 9 172
Statistical analysis title	BNT162b2 30 mcg versus Placebo
Statistical analysis description	Confidence interval (CI) for VE is derived based on the Clopper and Pearson method adjusted for surveillance time.
Comparison groups	BNT162b2 (30 mcg) v Placebo
Number of subjects included in analysis	37234
Analysis specification	Pre-specified
Analysis type	superiority
Method
Parameter type	Vaccine efficacy
Point estimate	94.7
Confidence interval
level	95%
sides	2-sided
lower limit	89.8
upper limit	97.6

Secondary: COVID-19 Incidence per 1000 Person-Years of Follow-up With or Without Evidence of Infection 7 Days After Second Dose of BNT162b2 Based on CDC-Defined Symptoms (Analysis for EUA): Phase 3 Top of page

Secondary: COVID-19 Incidence per 1000 Person-Years of Follow-up Without Evidence of Infection: 7 Days After Dose 2 Based on CDC Defined Symptoms (Analysis for EUA): Phase 3 Top of page
End point title	COVID-19 Incidence per 1000 Person-Years of Follow-up Without Evidence of Infection: 7 Days After Dose 2 Based on CDC Defined Symptoms (Analysis for EUA): Phase 3
End point description	COVID-19 incidence per 1000 person years follow-up without the evidence of infection were reported in this endpoint. Evaluable efficacy population included all eligible randomised subjects who received all vaccination(s) as randomized, with Dose 2 received within the predefined window (within 19-42 days after Dose 1) and have no other important protocol deviations as determined by the clinician on or before 7 days after Dose 2. HIV positive subjects were excluded from this analysis.
End point type	Secondary
End point timeframe	From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 2.213; Placebo - 2.220)
End point values BNT162b2 (30 mcg) Placebo Number of subjects analysed 17399 17495 Units: Cases     number (not applicable) 8 165
Statistical analysis title	BNT162b2 30 mcg versus Placebo
Statistical analysis description	After 7 Days: Confidence interval (CI) for VE is derived based on the Clopper and Pearson method adjusted for surveillance time.
Comparison groups	BNT162b2 (30 mcg) v Placebo
Number of subjects included in analysis	34894
Analysis specification	Pre-specified
Analysis type	superiority
Method
Parameter type	Vaccine efficacy
Point estimate	95.1
Confidence interval
level	95%
sides	2-sided
lower limit	90.2
upper limit	97.9

Secondary: COVID-19 Incidence per 1000 Person-Years of Follow-up Without Evidence of Infection: 7 Days After Dose 2 Based on CDC Defined Symptoms (Analysis for EUA): Phase 3 Top of page

Secondary: Severe COVID-19 Incidence per 1000 Person-Years of Follow-up With or Without Evidence of Infection: 7 Days After Dose 2: Phase 3 Top of page
End point title	Severe COVID-19 Incidence per 1000 Person-Years of Follow-up With or Without Evidence of Infection: 7 Days After Dose 2: Phase 3
End point description	Severe COVID-19 incidence per 1000 person years follow-up with or without the evidence of infection were reported in this endpoint. Evaluable efficacy population included all eligible randomised subjects who received all vaccination(s) as randomized, with Dose 2 received within the predefined window (within 19-42 days after Dose 1) and have no other important protocol deviations as determined by the clinician on or before 7 days after Dose 2. HIV positive subjects were excluded from this analysis.
End point type	Secondary
End point timeframe	From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 6.522; Placebo - 6.404)
End point values BNT162b2 (30 mcg) Placebo Number of subjects analysed 21649 21730 Units: Cases     number (not applicable) 1 21
Statistical analysis title	BNT162b2 30 mcg versus Placebo
Statistical analysis description	After 7 days: Confidence interval (CI) for VE is derived based on the Clopper and Pearson method adjusted for surveillance time.
Comparison groups	BNT162b2 (30 mcg) v Placebo
Number of subjects included in analysis	43379
Analysis specification	Pre-specified
Analysis type	superiority
Method
Parameter type	Vaccine efficacy
Point estimate	95.3
Confidence interval
level	95%
sides	2-sided
lower limit	70.9
upper limit	99.9

Secondary: Severe COVID-19 Incidence per 1000 Person-Years of Follow-up With or Without Evidence of Infection: 7 Days After Dose 2: Phase 3 Top of page

Secondary: COVID-19 Incidence per 1000 Person-Years of Follow-up Without Evidence of Infection: 14 Days After Dose 2 Based on CDC Defined Symptoms (Analysis for EUA): Phase 3 Top of page
End point title	COVID-19 Incidence per 1000 Person-Years of Follow-up Without Evidence of Infection: 14 Days After Dose 2 Based on CDC Defined Symptoms (Analysis for EUA): Phase 3
End point description	COVID-19 incidence per 1000 person years follow-up without the evidence of infection were reported in this endpoint. Evaluable efficacy population included all eligible randomised subjects who received all vaccination(s) as randomized, with Dose 2 received within the predefined window (within 19-42 days after Dose 1) and have no other important protocol deviations as determined by the clinician on or before 14 days after Dose 2. HIV positive subjects were excluded from this analysis.
End point type	Secondary
End point timeframe	From 14 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 1.886; Placebo - 1.891)
End point values BNT162b2 (30 mcg) Placebo Number of subjects analysed 16600 16647 Units: Cases     number (not applicable) 8 141
Statistical analysis title	BNT162b2 30 mcg versus Placebo
Statistical analysis description	After 14 days: Confidence interval (CI) for VE is derived based on the Clopper and Pearson method adjusted for surveillance time.
Comparison groups	BNT162b2 (30 mcg) v Placebo
Number of subjects included in analysis	33247
Analysis specification	Pre-specified
Analysis type	superiority
Method
Parameter type	Vaccine efficacy
Point estimate	94.3
Confidence interval
level	95%
sides	2-sided
lower limit	88.5
upper limit	97.6

Secondary: COVID-19 Incidence per 1000 Person-Years of Follow-up Without Evidence of Infection: 14 Days After Dose 2 Based on CDC Defined Symptoms (Analysis for EUA): Phase 3 Top of page

Secondary: Severe COVID-19 Incidence per 1000 Person-Years of Follow-up With or Without Evidence of Infection: 14 Days After Dose 2 (Analysis for EUA): Phase 3 Top of page
End point title	Severe COVID-19 Incidence per 1000 Person-Years of Follow-up With or Without Evidence of Infection: 14 Days After Dose 2 (Analysis for EUA): Phase 3
End point description	Severe COVID-19 incidence per 1000 person years follow-up with or without the evidence of infection were reported in this endpoint. Evaluable efficacy population included all eligible randomised subjects who received all vaccination(s) as randomized, with Dose 2 received within the predefined window (within 19-42 days after Dose 1) and have no other important protocol deviations as determined by the clinician on or before 14 days after Dose 2. HIV positive subjects were excluded from this analysis.
End point type	Secondary
End point timeframe	From 14 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 1.985; Placebo - 2.007)
End point values BNT162b2 (30 mcg) Placebo Number of subjects analysed 21649 21730 Units: Cases     number (not applicable) 1 3
Statistical analysis title	BNT162b2 30 mcg versus Placebo
Statistical analysis description	After 14 days: Confidence interval (CI) for VE is derived based on the Clopper and Pearson method adjusted for surveillance time.
Comparison groups	BNT162b2 (30 mcg) v Placebo
Number of subjects included in analysis	43379
Analysis specification	Pre-specified
Analysis type	superiority [63]
Method
Parameter type	Vaccine efficacy
Point estimate	66.3
Confidence interval
level	95%
sides	2-sided
lower limit	-125.6
upper limit	96.3
Notes [63] - Credible interval calculated using beta-binomial model with prior beta (0.700102, 1) adjusted for surveillance time.

Secondary: Severe COVID-19 Incidence per 1000 Person-Years of Follow-up With or Without Evidence of Infection: 14 Days After Dose 2 (Analysis for EUA): Phase 3 Top of page

Secondary: Severe COVID-19 Incidence per 1000 Person-Years of Follow-up Without Evidence of Infection: 7 Days After Dose 2: Phase 3 Top of page
End point title	Severe COVID-19 Incidence per 1000 Person-Years of Follow-up Without Evidence of Infection: 7 Days After Dose 2: Phase 3
End point description	Severe COVID-19 incidence per 1000 person years follow-up without the evidence of infection were reported in this endpoint. Evaluable efficacy population included all eligible randomised subjects who received all vaccination(s) as randomized, with Dose 2 received within the predefined window (within 19-42 days after Dose 1) and have no other important protocol deviations as determined by the clinician on or before 7 days after Dose 2. HIV positive subjects were excluded from this analysis.
End point type	Secondary
End point timeframe	From 7 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 6.257; Placebo - 6.120)
End point values BNT162b2 (30 mcg) Placebo Number of subjects analysed 20712 20713 Units: Cases     number (not applicable) 1 21
Statistical analysis title	BNT162b2 (30 mcg) versus Placebo
Statistical analysis description	Total surveillance time in 1000 person-years for the given endpoint across all subjects within each group at risk for the endpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
Comparison groups	BNT162b2 (30 mcg) v Placebo
Number of subjects included in analysis	41425
Analysis specification	Pre-specified
Analysis type	superiority
Method
Parameter type	Vaccine efficacy
Point estimate	95.3
Confidence interval
level	95%
sides	2-sided
lower limit	71
upper limit	99.9

Secondary: Severe COVID-19 Incidence per 1000 Person-Years of Follow-up Without Evidence of Infection: 7 Days After Dose 2: Phase 3 Top of page

Secondary: Severe COVID-19 Incidence per 1000 Person-Years of Follow-up Without Evidence of Infection: 14 Days After Dose 2 (Analysis for EUA): Phase 3 Top of page
End point title	Severe COVID-19 Incidence per 1000 Person-Years of Follow-up Without Evidence of Infection: 14 Days After Dose 2 (Analysis for EUA): Phase 3
End point description	Severe COVID-19 incidence per 1000 person years follow-up without the evidence of infection were reported in this endpoint. Evaluable efficacy population included all eligible randomised subjects who received all vaccination(s) as randomized, with Dose 2 received within the predefined window (within 19-42 days after Dose 1) and have no other important protocol deviations as determined by the clinician on or before 14 days after Dose 2. HIV positive subjects were excluded from this analysis.
End point type	Secondary
End point timeframe	From 14 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 1.888; Placebo - 1.901)
End point values BNT162b2 (30 mcg) Placebo Number of subjects analysed 16612 16663 Units: Cases     number (not applicable) 1 3
Statistical analysis title	BNT162b2 (30 mcg) versus Placebo
Statistical analysis description	Total surveillance time in 1000 person-years for the given endpoint across all subjects within each group at risk for the endpoint. Time period for COVID-19 case accrual is from 14 days after Dose 2 to the end of the surveillance period.
Comparison groups	BNT162b2 (30 mcg) v Placebo
Number of subjects included in analysis	33275
Analysis specification	Pre-specified
Analysis type	superiority [64]
Method
Parameter type	Vaccine efficacy
Point estimate	66.4
Confidence interval
level	95%
sides	2-sided
lower limit	-124.7
upper limit	96.3
Notes [64] - Credible interval calculated using beta-binomial model with prior beta (0.700102, 1) adjusted for surveillance time.

Secondary: Severe COVID-19 Incidence per 1000 Person-Years of Follow-up Without Evidence of Infection: 14 Days After Dose 2 (Analysis for EUA): Phase 3 Top of page

Secondary: COVID-19 Incidence per 1000 Person-Years of With or Without Evidence of Infection: 14 Days After Dose 2 (EUA Analysis): Phase 3 Top of page
End point title	COVID-19 Incidence per 1000 Person-Years of With or Without Evidence of Infection: 14 Days After Dose 2 (EUA Analysis): Phase 3
End point description	COVID-19 incidence per 1000 person years follow-up without the evidence of infection were reported in this endpoint. Evaluable efficacy population included all eligible randomised subjects who received all vaccination(s) as randomized, with Dose 2 received within the predefined window (within 19-42 days after Dose 1) and have no other important protocol deviations as determined by the clinician on or before 7 days after Dose 2. HIV positive subjects were excluded from this analysis.
End point type	Secondary
End point timeframe	From 14 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 1.984; Placebo - 1.995)
End point values BNT162b2 (30 mcg) Placebo Number of subjects analysed 17645 17746 Units: Cases     number (not applicable) 8 144
Statistical analysis title	BNT162b2 (30 mcg) vs Placebo
Statistical analysis description	Total surveillance time in 1000 person-years for the given endpoint across all subjects within each group at risk for the endpoint. Time period for COVID-19 case accrual is from 14 days after Dose 2 to the end of the surveillance period.
Comparison groups	BNT162b2 (30 mcg) v Placebo
Number of subjects included in analysis	35391
Analysis specification	Pre-specified
Analysis type	superiority
Method
Parameter type	Vaccine efficacy
Point estimate	94.4
Confidence interval
level	95%
sides	2-sided
lower limit	89.1
upper limit	97.3

Secondary: COVID-19 Incidence per 1000 Person-Years of With or Without Evidence of Infection: 14 Days After Dose 2 (EUA Analysis): Phase 3 Top of page

Secondary: COVID-19 Incidence per 1000 Person-Years of Follow-up Without Evidence of Infection: 14 Days After Dose 2 (EUA Analysis): Phase 3 Top of page
End point title	COVID-19 Incidence per 1000 Person-Years of Follow-up Without Evidence of Infection: 14 Days After Dose 2 (EUA Analysis): Phase 3
End point description	COVID-19 incidence per 1000 person years follow-up without the evidence of infection were reported in this endpoint. Evaluable efficacy population included all eligible randomised subjects who received all vaccination(s) as randomized, with Dose 2 received within the predefined window (within 19-42 days after Dose 1) and have no other important protocol deviations as determined by the clinician on or before 14 days after Dose 2. HIV positive subjects were excluded from this analysis.
End point type	Secondary
End point timeframe	From 14 days after Dose 2 (Surveillance time [1000 person-years]: BNT162b2 - 1.887; Placebo - 1.893)
End point values BNT162b2 (30 mcg) Placebo Number of subjects analysed 16612 16663 Units: Cases     number (not applicable) 8 139
Statistical analysis title	BNT162b2 (30 mcg) versus Placebo
Statistical analysis description	Total surveillance time in 1000 person-years for the given endpoint across all subjects within each group at risk for the endpoint. Time period for COVID-19 case accrual is from 14 days after Dose 2 to the end of the surveillance period.
Comparison groups	BNT162b2 (30 mcg) v Placebo
Number of subjects included in analysis	33275
Analysis specification	Pre-specified
Analysis type	superiority [65]
Method
Parameter type	Vaccine efficacy
Point estimate	94.2
Confidence interval
level	95%
sides	2-sided
lower limit	88.7
upper limit	97.2
Notes [65] - Credible interval calculated using beta-binomial model with prior beta (0.700102, 1) adjusted for surveillance time.

Secondary: COVID-19 Incidence per 1000 Person-Years of Follow-up Without Evidence of Infection: 14 Days After Dose 2 (EUA Analysis): Phase 3 Top of page

Secondary: Percentage Difference of Subjects Achieving Seroresponse (Reference Strain) 1 Month After Second Dose of BNT162b2SA and 1 Month After the Second Dose of BNT162b2 in BNT162b2-Naive Subjects: Phase 3 Top of page
End point title	Percentage Difference of Subjects Achieving Seroresponse (Reference Strain) 1 Month After Second Dose of BNT162b2SA and 1 Month After the Second Dose of BNT162b2 in BNT162b2-Naive Subjects: Phase 3
End point description	Percentage difference of subjects achieving seroresponse 1 month after second dose of BNT162b2SA and 1 month after the second dose of BNT162b2 in BNT162b2-naive subjects 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 have no other important protocol deviations as determined by the clinician. HIV positive subjects were excluded from this analysis.
End point type	Secondary
End point timeframe	1 Month After Dose 2
End point values BNT162b2SA (30 mcg) BNT162b2 (30 mcg) Number of subjects analysed 46 262 Units: Percentage difference     number (confidence interval 95%) 84.8 (71.1 to 93.7) 97.3 (94.6 to 98.9)
Statistical analysis title	BNT162b2 SA (30 mcg) versus BNT162b2 (30 mcg)
Statistical analysis description	2-Sided CI, based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.
Comparison groups	BNT162b2SA (30 mcg) v BNT162b2 (30 mcg)
Number of subjects included in analysis	308
Analysis specification	Pre-specified
Analysis type	non-inferiority
Method
Parameter type	Percentage difference
Point estimate	-12.5
Confidence interval
level	95%
sides	2-sided
lower limit	-25.7
upper limit	-4.5

Secondary: Percentage Difference of Subjects Achieving Seroresponse (Reference Strain) 1 Month After Second Dose of BNT162b2SA and 1 Month After the Second Dose of BNT162b2 in BNT162b2-Naive Subjects: Phase 3 Top of page

Secondary: GMR based on Geometric Mean Titer (Reference Strain) 1 Month After Second Dose of BNT162b2SA and 1 Month After the Second Dose of BNT162b2 in BNT162b2-Naive Subjects: Phase 3 Top of page
End point title	GMR based on Geometric Mean Titer (Reference Strain) 1 Month After Second Dose of BNT162b2SA and 1 Month After the Second Dose of BNT162b2 in BNT162b2-Naive Subjects: Phase 3
End point description	Subjects who had no serological or virological evidence (up to 1 month after receipt of Dose 2) of past SARS-CoV-2 infection (ie, N-binding antibody [serum] negative at Dose 1 visit, 1-month post–Dose 2 visit, SARS-CoV-2 not detected by NAAT [nasal swab] at Dose 1 visit, Dose 2 visit, and negative NAAT [nasal swab] at any unscheduled visit up to 1 month after Dose 2) were included in the analysis. 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.
End point type	Secondary
End point timeframe	1 Month After Dose 2
End point values BNT162b2SA (30 mcg) BNT162b2 (30 mcg) Number of subjects analysed 46 284 Units: Titer     geometric mean (confidence interval 95%) 356.7 (260.9 to 487.6) 820.3 (745.7 to 902.3)
Statistical analysis title	BNT162b2 SA (30 mcg) versus BNT162b2 (30mcg)
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the mean differences in the logarithms of the assay and the corresponding CIs (based on the Student t distribution).
Comparison groups	BNT162b2SA (30 mcg) v BNT162b2 (30 mcg)
Number of subjects included in analysis	330
Analysis specification	Pre-specified
Analysis type	non-inferiority
Method
Parameter type	Geometric Mean Ratio
Point estimate	0.43
Confidence interval
level	95%
sides	2-sided
lower limit	0.31
upper limit	0.6

Secondary: GMR based on Geometric Mean Titer (Reference Strain) 1 Month After Second Dose of BNT162b2SA and 1 Month After the Second Dose of BNT162b2 in BNT162b2-Naive Subjects: Phase 3 Top of page

Secondary: GMR based on Geometric Mean Titer of SA NT 1 Month After Second Dose of BNT162b2SA to 1 Month After the Second Dose (N2a) of BNT162b2 Naive Subjects: Phase 3 Top of page
End point title	GMR based on Geometric Mean Titer of SA NT 1 Month After Second Dose of BNT162b2SA to 1 Month After the Second Dose (N2a) of BNT162b2 Naive Subjects: Phase 3
End point description	GMR based on geometric mean titer of SA NT 1 month After second dose of BNT162b2SA to 1 month after the second dose of BNT162b2 naive subjects 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), had 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. HIV positive subjects were excluded from this analysis.
End point type	Secondary
End point timeframe	1 month after the second dose
End point values BNT162b2SA (30 mcg) BNT162b2 (30 mcg) Number of subjects analysed 272 304 Units: Titer     geometric mean (confidence interval 95%) 1358.0 (1242.0 to 1484.0) 273.1 (245.6 to 303.7)
Statistical analysis title	BNT162b2SA:SA NT vs BNT162b2:SA NT
Statistical analysis description	Statistical superiority of N2a is declared if the lower bound of the 2-sided 97.5% CI for the GMR is greater than 1.
Comparison groups	BNT162b2SA (30 mcg) v BNT162b2 (30 mcg)
Number of subjects included in analysis	576
Analysis specification	Pre-specified
Analysis type	non-inferiority
Method
Parameter type	Geometric Mean Ratio
Point estimate	4.97
Confidence interval
level	95%
sides	2-sided
lower limit	4.24
upper limit	5.83

Secondary: GMR based on Geometric Mean Titer of SA NT 1 Month After Second Dose of BNT162b2SA to 1 Month After the Second Dose (N2a) of BNT162b2 Naive Subjects: Phase 3 Top of page

Secondary: GMR of Neutralizing Titers (E3a) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Subjects That Received a Booster Dose of BNT162b2: Phase 3 Top of page
End point title	GMR of Neutralizing Titers (E3a) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Subjects That Received a Booster Dose of BNT162b2: Phase 3
End point description	Dose 3 booster evaluable immunogenicity population included all eligible randomised subjects who received 2 doses of BNT162b2 (or BNT162b1 for Phase 1) as initially randomised, with Dose 2 received within the predefined window (within 19-42 days after Dose 1), receive a third dose of BNT162b2 or BNT162b2SA as rerandomized (or receive a third dose of BNT162b2 for Phase 1), have at least 1 valid and determinate immunogenicity result after Dose 3 from a blood collection within an appropriate window (within 28-42 days after Dose 3), and had no other important protocol deviations as determined by the clinician. HIV positive subjects were excluded from this analysis.
End point type	Secondary
End point timeframe	1 Month After Booster Dose to 1 Month After Dose 2
End point values BNT162b2 (30 mcg): 1 Month After Booster Dose BNT162b2 (30 mcg): 1 Month After Dose 2 Number of subjects analysed 219 219 Units: Titer     number (confidence interval 95%) 2562.1 (2284.9 to 2872.8) 745.7 (656.5 to 847.1)
Statistical analysis title	BNT162b2:SA variant vs BNT162b2:Ref Strain
Statistical analysis description	E3a:Noninferiority is declared if the lower bound of the 2-sided 97.5% CI for the GMR is greater than 0.67 and the point estimate of the GMR is ≥0.8, if the previous objectives in the testing sequence are established.
Comparison groups	BNT162b2 (30 mcg): 1 Month After Booster Dose v BNT162b2 (30 mcg): 1 Month After Dose 2
Number of subjects included in analysis	438
Analysis specification	Pre-specified
Analysis type	non-inferiority [66]
Method
Parameter type	Geometric Mean Ratio
Point estimate	3.44
Confidence interval
level	95%
sides	2-sided
lower limit	2.93
upper limit	4.03
Notes [66] - While there are 438 data points (2 per subject) the number of subjects in this analysis was only 219.

Secondary: GMR of Neutralizing Titers (E3a) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Subjects That Received a Booster Dose of BNT162b2: Phase 3 Top of page

Secondary: Percentage Difference of Subjects Achieving Seroresponse (N2b) Comparison of 1 Month After Dose 2 Between Vaccine Groups: BNT162b2-Naïve Subjects Without Evidence of Infection up to 1 Month After Dose 2: Phase 3 Top of page
End point title	Percentage Difference of Subjects Achieving Seroresponse (N2b) Comparison of 1 Month After Dose 2 Between Vaccine Groups: BNT162b2-Naïve Subjects Without Evidence of Infection up to 1 Month After Dose 2: Phase 3
End point description	Seroresponse was defined as achieving a ≥4-fold rise from baseline (before Dose 1). If the baseline measurement was below the LLOQ, a postvaccination assay result ≥4 × LLOQ is considered a seroresponse. Sequential tests conducted was N1b. 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), had 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. HIV positive subjects were excluded from this analysis.
End point type	Secondary
End point timeframe	1 Month After Dose 2
End point values BNT162b2SA (30 mcg) BNT162b2 (30 mcg) Number of subjects analysed 272 304 Units: Percentage difference     number (confidence interval 97.5%) 97.1 (94.3 to 98.7) 57.6 (51.8 to 63.2)
Statistical analysis title	BNT162b2SA:SA NT vs BNT162b2:SA NT
Statistical analysis description	Noninferiority of N2b (SA titer) is declared if the lower bound of the 2-sided 97.5% CI for the percentage difference is greater than -10%. Statistical superiority of N2b is declared if the lower bound of the 2-sided 97.5% CI for the percentage difference is greater than 0%.
Comparison groups	BNT162b2SA (30 mcg) v BNT162b2 (30 mcg)
Number of subjects included in analysis	576
Analysis specification	Pre-specified
Analysis type	superiority
Method
Parameter type	Percentage difference
Point estimate	39.5
Confidence interval
level	97.5%
sides	2-sided
lower limit	32.7
upper limit	46.2

Secondary: Percentage Difference of Subjects Achieving Seroresponse (N2b) Comparison of 1 Month After Dose 2 Between Vaccine Groups: BNT162b2-Naïve Subjects Without Evidence of Infection up to 1 Month After Dose 2: Phase 3 Top of page

Secondary: GMR of Neutralising Titers (E4a) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Subjects: Phase 3 Top of page
End point title	GMR of Neutralising Titers (E4a) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Subjects: Phase 3
End point description	Dose 3 booster evaluable immunogenicity population included all eligible randomised subjects who received 2 doses of BNT162b2 (or BNT162b1 for Phase 1) as initially randomised, with Dose 2 received within the predefined window (within 19-42 days after Dose 1), receive a third dose of BNT162b2 or BNT162b2SA as rerandomized (or receive a third dose of BNT162b2 for Phase 1), have at least 1 valid and determinate immunogenicity result after Dose 3 from a blood collection within an appropriate window (within 28-42 days after Dose 3), and had no other important protocol deviations as determined by the clinician. HIV positive subjects were excluded from this analysis.
End point type	Secondary
End point timeframe	1 Month After Booster Dose to 1 Month After Dose 2
End point values BNT162b2SA (30 mcg):1 Month After Booster Dose BNT162b2SA 30 mcg: 1 Month After Dose 2 Number of subjects analysed 242 242 Units: Titer     number (confidence interval 95%) 1676.0 (1496.2 to 1877.3) 686.0 (612.0 to 769.0)
Statistical analysis title	BNT162b2SA:ref strain vs BNT162b2:ref strain
Statistical analysis description	E4a:Noninferiority is declared if the lower bound of the 2-sided 97.5% CI for the GMR is greater than 0.67 and the point estimate of the GMR is ≥0.8, if the previous objectives in the testing sequence are established.
Comparison groups	BNT162b2SA (30 mcg):1 Month After Booster Dose v BNT162b2SA 30 mcg: 1 Month After Dose 2
Number of subjects included in analysis	484
Analysis specification	Pre-specified
Analysis type	non-inferiority [67]
Method
Parameter type	Geometric Mean Ratio
Point estimate	2.44
Confidence interval
level	95%
sides	2-sided
lower limit	2.14
upper limit	2.8
Notes [67] - While there are 484 data points (2 per subject) the number of subjects in this analysis was only 242.

Secondary: GMR of Neutralising Titers (E4a) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Subjects: Phase 3 Top of page

Secondary: Percentage Difference of Subjects Achieving Seroresponse (E3b) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Subjects That Received a Booster Dose of BNT162b2: Phase 3 Top of page
End point title	Percentage Difference of Subjects Achieving Seroresponse (E3b) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Subjects That Received a Booster Dose of BNT162b2: Phase 3
End point description	Percentage difference of subjects achieving seroresponse – comparison of 1 month after booster dose to 1 month after dose 2 BNT162b2-experienced subjects without evidence of infection up to 1 month after booster dose who were rerandomized to receive 1 booster dose were reported in this endpoint. Dose 3 booster evaluable immunogenicity population included all eligible randomised subjects who received 2 doses of BNT162b2 (or BNT162b1 for Phase 1) as initially randomised, with Dose 2 received within the predefined window (within 19-42 days after Dose 1), receive a third dose of BNT162b2 or BNT162b2SA as rerandomized (or receive a third dose of BNT162b2 for Phase 1), have at least 1 valid and determinate immunogenicity result after Dose 3 from a blood collection within an appropriate window (within 28-42 days after Dose 3), and had no other important protocol deviations as determined by the clinician. HIV positive subjects were excluded from this analysis.
End point type	Secondary
End point timeframe	1 Month After Booster Dose to 1 Month After Dose 2
End point values BNT162b2 (30 mcg): 1 Month After Booster Dose BNT162b2 (30 mcg): 1 Month After Dose 2 Number of subjects analysed 207 207 Units: Percentage of subjects     number (confidence interval 95%) 100.0 (98.2 to 100.0) 95.2 (91.3 to 97.7)
Statistical analysis title	BNT162b2:SA variant vs BNT162b2:Ref Strain
Statistical analysis description	E3b: Noninferiority is declared if the lower bound of the 2-sided 97.5% CI for the GMR is greater than 0.67 and the point estimate of the GMR is >=0.8, if the previous objectives in the testing sequence are established.
Comparison groups	BNT162b2 (30 mcg): 1 Month After Booster Dose v BNT162b2 (30 mcg): 1 Month After Dose 2
Number of subjects included in analysis	414
Analysis specification	Pre-specified
Analysis type	non-inferiority [68]
Method
Parameter type	Percentage difference
Point estimate	4.8
Confidence interval
level	97.5%
sides	2-sided
lower limit	1.3
upper limit	8.3
Notes [68] - While there are 414 data points (2 per subject) the number of subjects in this analysis was only 207.

Secondary: Percentage Difference of Subjects Achieving Seroresponse (E3b) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Subjects That Received a Booster Dose of BNT162b2: Phase 3 Top of page

Secondary: Percentage Difference of Subjects Achieving Seroresponse (E4b) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Subjects: Phase 3 Top of page
End point title	Percentage Difference of Subjects Achieving Seroresponse (E4b) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Subjects: Phase 3
End point description	Percentage difference of subjects achieving seroresponse – comparison of 1 month after booster dose to 1 month after dose 2 BNT162b2-experienced subjects without evidence of infection up to 1 month after booster dose who were rerandomized to receive 1 booster dose were reported in this endpoint. Dose 3 booster evaluable immunogenicity population included all eligible randomised subjects who received 2 doses of BNT162b2 (or BNT162b1 for Phase 1) as initially randomised, with Dose 2 received within the predefined window (within 19-42 days after Dose 1), receive a third dose of BNT162b2 or BNT162b2SA as rerandomized (or receive a third dose of BNT162b2 for Phase 1), have at least 1 valid and determinate immunogenicity result after Dose 3 from a blood collection within an appropriate window (within 28-42 days after Dose 3), and had no other important protocol deviations as determined by the clinician. HIV positive subjects were excluded from this analysis.
End point type	Secondary
End point timeframe	1 Month After Booster Dose to 1 Month After Dose 2
End point values BNT162b2SA (30 mcg): 1 Month After Booster Dose BNT162b2SA 30 mcg: 1 Month After Dose 2 Number of subjects analysed 215 215 Units: Percentage of subjects     number (confidence interval 95%) 99.5 (97.4 to 100.0) 94.0 (89.9 to 96.7)
Statistical analysis title	BNT162b2SA:Ref strain vs BNT162b2:Ref strain
Statistical analysis description	E4b: Noninferiority is declared if the lower bound of the 2-sided 97.5% CI for the percentage difference is greater than -10, if the previous objectives in testing sequence are established.
Comparison groups	BNT162b2SA (30 mcg): 1 Month After Booster Dose v BNT162b2SA 30 mcg: 1 Month After Dose 2
Number of subjects included in analysis	430
Analysis specification	Pre-specified
Analysis type	non-inferiority [69]
Method
Parameter type	Percentage difference
Point estimate	5.6
Confidence interval
level	97.5%
sides	2-sided
lower limit	1.6
upper limit	9.4
Notes [69] - While there are 430 data points (2 per subject) the number of subjects in this analysis was only 215.

Secondary: Percentage Difference of Subjects Achieving Seroresponse (E4b) - Comparison of 1 Month After Booster Dose to 1 Month After Dose 2: BNT162b2-Experienced Subjects: Phase 3 Top of page

Secondary: GMR of SA Variant NT 1 Month After Second Booster Dose to 1 Month After Dose 2 of BNT162b2 in Subjects Assigned to Receive 2 Booster Doses of BNT1612b2SA: Phase 3 Top of page
End point title	GMR of SA Variant NT 1 Month After Second Booster Dose to 1 Month After Dose 2 of BNT162b2 in Subjects Assigned to Receive 2 Booster Doses of BNT1612b2SA: Phase 3
End point description	GMR of SA variant NT 1 month after second booster dose to 1 month after dose 2 of BNT162b2 in subjects assigned to receive 2 booster doses of BNT1612b2SA were reported in this endpoint. Dose 4 evaluable immunogenicity included all eligible randomised subjects who received 2 doses of BNT162b2 as initially randomized, with Dose 2 received within the predefined window (within 19-42 days after Dose 1), received 2 booster doses of BNT162b2SA as rerandomized, had at least 1 valid and determinate immunogenicity result after Dose 4 from a blood collection within an appropriate window (within 28-42 days after Dose 4), and have no other important protocol deviations as determined by the clinician. HIV positive subjects were excluded from this analysis.
End point type	Secondary
End point timeframe	1 Month After Second Booster Dose to 1 Month After Dose 2 of BNT162b2
End point values BNT162b2 (30 mcg): 1 Month After Second Booster Dose BNT162b2 (30 mcg): 1 Month After Dose 2 Number of subjects analysed 27 27 Units: Ratio     geometric mean (confidence interval 95%) 4981.2 (3690.8 to 6722.8) 1076.5 (854.5 to 1356.1)
Statistical analysis title	BNT162b2SA booster vs BNT162b2
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the mean differences in the logarithms of the assay and the corresponding CIs (based on the Student t distribution).
Comparison groups	BNT162b2 (30 mcg): 1 Month After Second Booster Dose v BNT162b2 (30 mcg): 1 Month After Dose 2
Number of subjects included in analysis	54
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric Mean Ratio
Point estimate	4.63
Confidence interval
level	95%
sides	2-sided
lower limit	3.56
upper limit	6.01

Secondary: GMR of SA Variant NT 1 Month After Second Booster Dose to 1 Month After Dose 2 of BNT162b2 in Subjects Assigned to Receive 2 Booster Doses of BNT1612b2SA: Phase 3 Top of page

Secondary: Percentage Difference of Subjects Achieving Seroresponse for SA Variant NT Comparison of 1 Month after Second Booster Dose to 1 Month After Dose 2 of BNT162b2 in Subjects Assigned to Receive 2 Booster Doses of BNT162b2SA: Phase 3 Top of page
End point title	Percentage Difference of Subjects Achieving Seroresponse for SA Variant NT Comparison of 1 Month after Second Booster Dose to 1 Month After Dose 2 of BNT162b2 in Subjects Assigned to Receive 2 Booster Doses of BNT162b2SA: Phase 3
End point description	Percentage difference of subjects achieving seroresponse comparison of 1 month after first dose of BNT162b2 was reported in this endpoint. Dose 4 booster evaluable immunogenicity included all eligible randomised subjects who received 2 doses of BNT162b2 as initially randomized, with Dose 2 received within the predefined window (within 19-42 days after Dose 1), received 2 booster doses of BNT162b2SA as rerandomized, had at least 1 valid and determinate immunogenicity result after Dose 4 from a blood collection within an appropriate window (within 28-42 days after Dose 4), and had no other important protocol deviations as determined by the clinician. HIV positive subjects were excluded from this analysis.
End point type	Secondary
End point timeframe	1 Month after Second Booster Dose to 1 Month After Dose 2 of BNT162b2
End point values BNT162b2 (30 mcg): 1 Month After Second Booster Dose BNT162b2 (30 mcg): 1 Month After Dose 2 Number of subjects analysed 27 27 Units: Percentage difference     number (confidence interval 95%) 100.0 (87.2 to 100.0) 100.0 (87.2 to 100.0)
Statistical analysis title	BNT162b2SA booster vs BNT162b2
Comparison groups	BNT162b2 (30 mcg): 1 Month After Second Booster Dose v BNT162b2 (30 mcg): 1 Month After Dose 2
Number of subjects included in analysis	54
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Percentage difference
Point estimate	0
Confidence interval
level	95%
sides	2-sided
lower limit	-6.8
upper limit	6.8

Secondary: Percentage Difference of Subjects Achieving Seroresponse for SA Variant NT Comparison of 1 Month after Second Booster Dose to 1 Month After Dose 2 of BNT162b2 in Subjects Assigned to Receive 2 Booster Doses of BNT162b2SA: Phase 3 Top of page

Secondary: Percentage Difference of Subjects Achieving Seroresponse for SA Variant NT: BNT162b2-Experienced Subjects Without Evidence of Infection up to 1 Month After Booster Dose Who Were Rerandomised to Receive 1 Booster Dose: Phase 3 Top of page
End point title	Percentage Difference of Subjects Achieving Seroresponse for SA Variant NT: BNT162b2-Experienced Subjects Without Evidence of Infection up to 1 Month After Booster Dose Who Were Rerandomised to Receive 1 Booster Dose: Phase 3
End point description	Percentage difference of subjects achieving seroresponse for SA variant NT: BNT162b2-experienced subjects without evidence of infection up to 1 month after booster dose who were rerandomised to receive 1 booster dose were reported in this endpoint. All eligible randomised subjects who received 2 doses of BNT162b2 as initially randomised, with Dose 2 received within the predefined window (within 19-42 days after Dose 1), received a third dose of BNT162b2 or BNT162b2SA as rerandomized, had at least 1 valid and determinate immunogenicity result after Dose 3 from blood collected within an appropriate window (within 28-42 days after Dose 3), and had no other important protocol deviations as determined by the clinician. HIV positive subjects were excluded from this analysis.
End point type	Secondary
End point timeframe	1 Month After Booster Dose
End point values BNT162b2SA (30 mcg) BNT162b2 (30 mcg) Number of subjects analysed 262 243 Units: Percentage difference     number (confidence interval 95%) 99.2 (97.3 to 99.9) 99.6 (97.7 to 100.0)
Statistical analysis title	BNT162b2SA (30 mcg) versus BNT162b2 (30 mcg)
Statistical analysis description	Difference in proportions, expressed as a percentage (BNT162b2SA [30 μg] – BNT162b2 [30 μg]).
Comparison groups	BNT162b2SA (30 mcg) v BNT162b2 (30 mcg)
Number of subjects included in analysis	505
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Percentage difference
Point estimate	-0.4
Confidence interval
level	95%
sides	2-sided
lower limit	-2.4
upper limit	1.6

Secondary: Percentage Difference of Subjects Achieving Seroresponse for SA Variant NT: BNT162b2-Experienced Subjects Without Evidence of Infection up to 1 Month After Booster Dose Who Were Rerandomised to Receive 1 Booster Dose: Phase 3 Top of page

Secondary: GMR of SA Variant NT: BNT162b2-Experienced Subjects Without Evidence of Infection up to 1 Month After Booster Dose Who Were Rerandomised to Receive 1 Booster Dose: Phase 3 Top of page
End point title	GMR of SA Variant NT: BNT162b2-Experienced Subjects Without Evidence of Infection up to 1 Month After Booster Dose Who Were Rerandomised to Receive 1 Booster Dose: Phase 3
End point description	GMR of SA Variant NT: BNT162b2-experienced subjects without evidence of infection up to 1 month after booster dose who were rerandomised to receive 1 booster dose were reported in this endpoint. All eligible randomised subjects who received 2 doses of BNT162b2 (or BNT162b1 for Phase 1) as initially randomised, with Dose 2 received within the predefined window (within 19-42 days after Dose 1), received a third dose of BNT162b2 or BNT162b2SA as rerandomized (or received a third dose of BNT162b2 for Phase 1), had at least 1 valid and determinate immunogenicity result after Dose 3 from blood collected within an appropriate window (within 28-42 days after Dose 3), and had no other important protocol deviations as determined by the clinician. HIV positive subjects were excluded from this analysis.
End point type	Secondary
End point timeframe	1 Month After Booster Dose
End point values BNT162b2SA (30 mcg) BNT162b2 (30 mcg) Number of subjects analysed 262 243 Units: Titer     geometric mean (confidence interval 95%) 3536.4 (3131.3 to 3994.0) 2453.0 (2190.0 to 2747.7)
Statistical analysis title	BNT162b2SA (30 mcg) versus BNT162b2 (30 mcg)
Statistical analysis description	GMRs and 2-sided 95% CIs were calculated by exponentiating the mean differences in the logarithms of the assay and the corresponding CIs (based on the Student t distribution).
Comparison groups	BNT162b2SA (30 mcg) v BNT162b2 (30 mcg)
Number of subjects included in analysis	505
Analysis specification	Pre-specified
Analysis type	other
Method
Parameter type	Geometric Mean Ratio
Point estimate	1.44
Confidence interval
level	95%
sides	2-sided
lower limit	1.22
upper limit	1.7

Secondary: GMR of SA Variant NT: BNT162b2-Experienced Subjects Without Evidence of Infection up to 1 Month After Booster Dose Who Were Rerandomised to Receive 1 Booster Dose: Phase 3 Top of page

Adverse events Top of page
Adverse events information
Timeframe for reporting adverse events	Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 months 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 20 mcg
Reporting group description	Blinded Placebo-Controlled Follow-up Period - Phase 1 / BNT162b1 20 mcg
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 30 mcg
Reporting group description	Blinded Placebo-Controlled Follow-up Period - Phase 1 / BNT162b1 30 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 - BNT162b2 10 mcg
Reporting group description	Blinded Placebo-Controlled Follow-up Period - Phase 1 / BNT162b2 10 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 - Ph1 - BNT162b2 30 mcg
Reporting group description	Blinded Placebo-Controlled Follow-up Period - Phase 1 / BNT162b2 30 mcg
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 - Placebo
Reporting group description	Blinded Placebo-Controlled Follow-up Period - Phase 1 / Placebo
Reporting group title	PC Fup Period - Ph2/3 Sub >=16 YOA (Final) - Placebo
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 - BNT162b2 20 mcg
Reporting group description	Blinded Placebo-Controlled Follow-up Period - Phase 1 / BNT162b2 20 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 - 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	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	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)
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	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	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	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 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	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	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	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	PC Fup Period - Ph2 - BNT162b2 (30 mcg)
Reporting group description	Blinded Placebo-Controlled Follow-up Period - Phase 2 / BNT162b2 (30 mcg)
Reporting group title	PC Fup Period - Ph2 - Placebo
Reporting group description	Blinded Placebo-Controlled Follow-up Period - Phase 2 / Placebo
Serious adverse events PC Fup Period - Ph1 - BNT162b1 20 mcg PC Fup Period - Ph1 - BNT162b1 10 mcg PC Fup Period - Ph1 - BNT162b1 30 mcg PC Fup Period - Ph1 - BNT162b1 100 mcg PC Fup Period - Ph1 - BNT162b2 10 mcg PC Fup Period - Ph2/3 Sub >=16 YOA (Final) - BNT162b2 (30 mcg) PC Fup Period - Ph1 - BNT162b2 30 mcg OL Fup Period - Ph1 - Placebo/BNT162b2 30 mcg PC Fup Period - Ph1 - Placebo PC Fup Period - Ph2/3 Sub >=16 YOA (Final) - Placebo PC Fup Period - Ph1 - BNT162b2 20 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 - Ph3 Sub 12-15 YOA - BNT162b2 (30 mcg) BNT162b2-Naive Subjects / BNT162b2SA (30 mcg) Sub Rerand to Receive 1 Booster Dose - BNT162b2SA (30 mcg) Sub Rerand to 1 Booster Dose - BNT162b2 (30 mcg) OL Fup Period - Ph3 Sub 12-15 YOA - Placebo/BNT162b2 (30 mcg) Ph2/3 - Subjects Who are Part of PA 18 - BNT162b2 (30 mcg) Add Booster for 1 Booster Dose Sub - BNT162b2 (30 mcg) Add Booster for 2 Booster Doses Sub - BNT162b2 (30 mcg) Add Booster for Low Dose Booster Sub - BNT162b2 (30 mcg) Naive Sub Received Booster Dose (PA 18) - BNT162b2 (30 mcg) Sub Assigned to 2 Booster Doses - BNT162b2SA (30 mcg, 2 doses) Sub Rerand to Receive 1 Booster Dose - BNT162b2 (10 mcg) Sub Rerand to Receive 1 Booster Dose - BNT162b2 (5 mcg) PC Fup Period - Ph2 - BNT162b2 (30 mcg) PC Fup Period - Ph2 - Placebo Total subjects affected by serious adverse events      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 428 / 21910 (1.95%) 1 / 24 (4.17%) 0 / 35 (0.00%) 0 / 39 (0.00%) 291 / 21911 (1.33%) 1 / 24 (4.17%) 2 / 1129 (0.18%) 353 / 20267 (1.74%) 13 / 1131 (1.15%) 4 / 324 (1.23%) 2 / 315 (0.63%) 2 / 306 (0.65%) 13 / 1014 (1.28%) 67 / 23295 (0.29%) 1 / 378 (0.26%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 1 / 30 (3.33%) 0 / 76 (0.00%) 1 / 79 (1.27%) 1 / 180 (0.56%) 0 / 180 (0.00%)      number of deaths (all causes) 0 0 0 0 0 60 0 0 0 21 0 0 38 0 0 0 0 1 46 0 0 0 0 0 0 0 2 0      number of deaths resulting from adverse events 0 0 0 0 0 27 0 0 0 15 0 0 21 0 0 0 0 0 1 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 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 0 / 0 0 / 0 Adenocarcinoma gastric      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 1 / 180 (0.56%) 0 / 180 (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 / 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 of colon      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 3 / 21910 (0.01%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 1 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 1 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 Adenocarcinoma pancreas      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 3 / 21910 (0.01%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 1 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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 / 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 / 1 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 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 0 / 0 0 / 0 B-cell lymphoma      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 2 / 21910 (0.01%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 2 / 21911 (0.01%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 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 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Bladder cancer      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 6 / 21910 (0.03%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 4 / 21911 (0.02%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 3 / 20267 (0.01%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 6 0 / 0 0 / 0 0 / 0 0 / 4 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 2 / 20267 (0.01%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 1 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 1 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 Colorectal adenoma      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 2 / 20267 (0.01%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 1 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 1 0 / 0 0 / 0 0 / 2 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 Endometrial cancer      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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 Gastrointestinal stromal tumour      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 1 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 Hepatic cancer      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 2 / 21911 (0.01%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 2 / 20267 (0.01%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 1 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 2 0 / 0 0 / 0 0 / 2 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 Invasive breast carcinoma      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 1 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 Invasive ductal breast carcinoma      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 2 / 21910 (0.01%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 2 / 21911 (0.01%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 5 / 20267 (0.02%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 2 0 / 0 0 / 0 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 2 / 20267 (0.01%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 2 / 21911 (0.01%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 2 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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 Lung neoplasm malignant      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 2 / 20267 (0.01%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 5 / 21911 (0.02%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 2 / 20267 (0.01%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 5 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 1 / 324 (0.31%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 Meningioma      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 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 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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 Metastases to lymph nodes      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 2 / 21911 (0.01%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 1 / 306 (0.33%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 1 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 2 / 21911 (0.01%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 2 / 21910 (0.01%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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 Pancreatic neuroendocrine tumour      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 2 / 21911 (0.01%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 1 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 Polycythaemia vera      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 3 / 21910 (0.01%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 2 / 21911 (0.01%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 9 / 20267 (0.04%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 1 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 2 0 / 0 0 / 0 0 / 9 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 Prostate cancer metastatic      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 stage II      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 1 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 Rhabdomyosarcoma      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 Tonsil cancer      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 2 / 21910 (0.01%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 4 / 21911 (0.02%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 2 / 20267 (0.01%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 4 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 neoplasm      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 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 0 / 0 0 / 0 Vascular disorders Accelerated hypertension      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 1 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 Aortic aneurysm      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 2 / 21910 (0.01%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 1 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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 Aortic dissection      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 2 / 21911 (0.01%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 2 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 3 / 21910 (0.01%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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 Deep vein thrombosis      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 4 / 21910 (0.02%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 4 / 21911 (0.02%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 4 / 20267 (0.02%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 1 / 315 (0.32%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 4 0 / 0 0 / 0 0 / 0 0 / 4 0 / 0 0 / 0 0 / 4 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 Hypertension      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 3 / 21910 (0.01%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 2 / 20267 (0.01%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 2 / 21910 (0.01%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 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 0 / 0 0 / 0 Iliac artery dissection      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 2 / 21911 (0.01%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 6 / 21910 (0.03%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 3 / 21911 (0.01%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 8 / 20267 (0.04%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 1 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 6 0 / 0 0 / 0 0 / 0 0 / 3 0 / 0 0 / 0 0 / 8 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 1 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 Retained products of conception      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 1 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 Chest pain      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 5 / 21910 (0.02%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 2 / 20267 (0.01%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 1 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 5 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 2 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 Death      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 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 Drug withdrawal syndrome      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 2 / 20267 (0.01%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 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 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 4 / 21910 (0.02%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 3 / 20267 (0.01%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 4 0 / 0 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 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 0 / 0 0 / 0 Treatment noncompliance      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 2 / 21910 (0.01%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 2 / 21911 (0.01%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 2 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 Ovarian cyst      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 2 / 21910 (0.01%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 2 / 20267 (0.01%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 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 0 / 0 0 / 0 Acute respiratory failure      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 2 / 21910 (0.01%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 2 / 21911 (0.01%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 5 / 20267 (0.02%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 2 0 / 0 0 / 0 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      deaths causally related to treatment / all 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 / 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 Asthma      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 2 / 21910 (0.01%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 4 / 21910 (0.02%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 5 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      deaths 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 Diaphragmatic paralysis      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 3 / 20267 (0.01%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 2 / 20267 (0.01%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 1 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 5 / 21910 (0.02%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 7 / 21911 (0.03%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 11 / 20267 (0.05%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 5 0 / 0 0 / 0 0 / 0 0 / 7 0 / 0 0 / 0 0 / 11 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 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 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Respiratory failure      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 1 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 1 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 / 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 Alcohol withdrawal syndrome      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 2 / 20267 (0.01%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 1 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 1 / 1014 (0.10%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 2 / 20267 (0.01%) 1 / 1131 (0.09%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 1 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 2 0 / 1 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 Bipolar I disorder      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 2 / 21911 (0.01%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 2 / 20267 (0.01%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 2 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 2 / 20267 (0.01%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths 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 / 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 Conversion disorder      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 1 / 1131 (0.09%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 4 / 21910 (0.02%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 3 / 20267 (0.01%) 3 / 1131 (0.27%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 1 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 4 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 3 0 / 4 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 Depression suicidal      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 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 0 / 0 0 / 0 Drug dependence      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 2 / 21911 (0.01%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 2 / 20267 (0.01%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 1 / 1014 (0.10%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 3 0 / 0 0 / 0 0 / 2 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 1 / 1014 (0.10%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 1 0 / 0 0 / 0 0 / 1 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 2 / 21911 (0.01%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 5 / 20267 (0.02%) 4 / 1131 (0.35%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 1 / 1014 (0.10%) 1 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 3 0 / 0 0 / 0 0 / 6 0 / 4 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 1 / 1131 (0.09%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 1 / 1014 (0.10%) 1 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 1 0 / 0 0 / 0 0 / 1 0 / 1 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 Acute hepatic failure      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 Alcoholic liver disease      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 1 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 Autoimmune hepatitis      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 2 / 21910 (0.01%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 2 / 21910 (0.01%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 1 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 Cholangitis      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 2 / 21910 (0.01%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 2 / 20267 (0.01%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 1 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 1 0 / 0 0 / 0 0 / 2 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 Cholecystitis acute      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 7 / 21910 (0.03%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 3 / 21911 (0.01%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 2 / 23295 (0.01%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 7 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 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 6 / 21910 (0.03%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 6 / 20267 (0.03%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 6 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 6 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 1 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 Hepatitis acute      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 1 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 1 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 Hepatocellular injury      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 1 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 Jaundice cholestatic      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 1 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 Portal vein thrombosis      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 1 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 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 0 / 0 0 / 0 Alcohol poisoning      subjects affected / exposed 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 1 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 0 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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 / 24 (0.00%) 0 / 12 (0.00%) 0 / 24 (0.00%) 0 / 21910 (0.00%) 0 / 24 (0.00%) 0 / 35 (0.00%) 0 / 39 (0.00%) 0 / 21911 (0.00%) 0 / 24 (0.00%) 0 / 1129 (0.00%) 1 / 20267 (0.00%) 0 / 1131 (0.00%) 0 / 324 (0.00%) 0 / 315 (0.00%) 0 / 306 (0.00%) 0 / 1014 (0.00%) 0 / 23295 (0.00%) 0 / 378 (0.00%) 0 / 15 (0.00%) 0 / 71 (0.00%) 0 / 236 (0.00%) 0 / 30 (0.00%) 0 / 76 (0.00%) 0 / 79 (0.00%) 0 / 180 (0.00%) 0 / 180 (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 / 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      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 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