Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44416   clinical trials with a EudraCT protocol, of which   7423   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase 1b/2, Open-Label, Multicentre Study Assessing the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of MEDI4736 in Combination With AZD9150 or AZD5069 in Patients With Advanced Solid Malignancies and Subsequently Comparing AZD9150 and AZD5069 Both as Monotherapy and in Combination With MEDI4736 as Second Line Treatment in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

    Summary
    EudraCT number
    		 2015-002525-19
    Trial protocol
    		 DE   ES   BE   IT  
    Global end of trial date
    08 Oct 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Oct 2026
    First version publication date
    11 Oct 2026
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    D5660C00004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02499328
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Astrazeneca
    Sponsor organisation address
    One Medimmune Way, Gaithersburg, United States, 20878
    Public contact
    Global Clinical Lead, Astrazeneca, +1 8772409479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, Astrazeneca, +1 8772409479, information.center@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    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?
    No
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    17 Apr 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Apr 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Oct 2025
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Part A (dose escalation-US ONLY) To determine the MTDs or recommended doses for dose-expansion and to determine the safety profiles of either AZD9150 or AZD5069 in combination with MEDI4736 and/or MEDI4736/tremelimumab in patients with advanced solid malignancies refractory to standard therapy or for which no standard of care regimen currently exists. Part B (dose expansion-NA, EU) to evaluate the ORR of AZD9150 and AZD5069 both as monotherapy and in combination with MEDI4736 in the second-line treatment of patients with RM-SCCHN and in patients with no prior exposure to anti-PD-(L)1 therapies and also in who have not received prior systemic treatment for recurrent or metastatic SCCHN (1L RM SCCHN). To evaluate ORR of AZD9150 as fixed dosed Q2W in patients with no prior exposure to anti-PD-(L)1 therapies and who have not received prior systemic treatment for recurrent or metastatic SCCHN (1L RM SCCHN).
    Protection of trial subjects
    Long term monitoring/follow up
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Jul 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 1 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 178
    Country: Number of subjects enrolled
    Belgium: 29
    Country: Number of subjects enrolled
    Germany: 26
    Country: Number of subjects enrolled
    Spain: 63
    Country: Number of subjects enrolled
    United Kingdom: 40
    Country: Number of subjects enrolled
    Italy: 4
    Worldwide total number of subjects
    340
    EEA total number of subjects
    122
    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)
    0
    Adults (18-64 years)
    212
    From 65 to 84 years
    123
    85 years and over
    5

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 448 patients were screened and 340 were enrolled

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 A1C1: AZD9150 2mg/kg + MEDI4736 20mg/kg
    Arm description
    		 2mg/kg QW danvatirsen IV + 20mg/kg Q4W durvalumab
    Arm type
    		 Experimental

    Investigational medicinal product name
    Danvatirsen (AZD9150)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    2mg/kg QW (based on Ideal body weight determined using Devine formula) as IV infusion over 60 mintues.

    Investigational medicinal product name
    MEDI4736 (durvalumab)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    20 mg/kg Q4W as IV infusion over 60 mintues.

    Arm title
    		 A1C2: AZD9150 3mg/kg + MEDI4736 20mg/kg
    Arm description
    		 3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab
    Arm type
    		 Experimental

    Investigational medicinal product name
    MEDI4736 (durvalumab)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    20 mg/kg Q4W as IV infusion over 60 mintues.

    Investigational medicinal product name
    Danvatirsen (AZD9150)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3mg/kg QW (based on Ideal body weight determined using Devine formula) as IV infusion over 60 mintues.

    Arm title
    		 A2C1: AZD5069 40mg BID + MEDI4736 20mg/kg
    Arm description
    		 40mg BID AZD5069 (PO) + 20mg/kg Q4W durvalumab
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZD5069
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg BID

    Investigational medicinal product name
    MEDI4736 (durvalumab)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    20 mg/kg Q4W as IV infusion over 60 mintues.

    Arm title
    		 A2C2: AZD5069 80mg BID + MEDI4736 20mg/kg
    Arm description
    		 80mg BID AZD5069 (PO) + 20mg/kg Q4W durvalumab
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZD5069
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    80 mg BID

    Investigational medicinal product name
    MEDI4736 (durvalumab)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    20 mg/kg Q4W as IV infusion over 60 mintues.

    Arm title
    		 A3C1: AZD5069 80mg BID + MEDI4736 20mg/kg
    Arm description
    		 80 mg BID AZD5069 (PO) with scheduled dose holds and titrations + 20 mg/kg Q4W durvalumab
    Arm type
    		 Experimental

    Investigational medicinal product name
    MEDI4736 (durvalumab)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    20 mg/kg Q4W as IV infusion over 60 mintues.

    Investigational medicinal product name
    AZD5069
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    80 mg BID

    Arm title
    		 A4C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme
    Arm description
    		 3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab + 1 mg/kg Q4W tremelimumab
    Arm type
    		 Experimental

    Investigational medicinal product name
    Danvatirsen (AZD9150)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3mg/kg QW (based on Ideal body weight determined using Devine formula) as IV infusion over 60 mintues.

    Investigational medicinal product name
    MEDI4736 (durvalumab)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    20 mg/kg Q4W as IV infusion over 60 mintues.

    Investigational medicinal product name
    Tremelimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Tremelimumab 1 mg/kg Q4W as IV infusion over 60 mintues - for a total of 4 cycles (up to 4 doses)

    Arm title
    		 A4C2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme
    Arm description
    		 2 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab + 1 mg/kg Q4W tremelimumab
    Arm type
    		 Experimental

    Investigational medicinal product name
    Danvatirsen (AZD9150)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    2mg/kg QW (based on Ideal body weight determined using Devine formula) as IV infusion over 60 mintues.

    Investigational medicinal product name
    Tremelimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Tremelimumab 1 mg/kg Q4W as IV infusion over 60 mintues - for a total of 4 cycles (up to 4 doses)

    Investigational medicinal product name
    MEDI4736 (durvalumab)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    20 mg/kg Q4W as IV infusion over 60 mintues.

    Arm title
    		 A4C3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme
    Arm description
    		 3 mg/kg Q2W danvatirsen IV + 20 mg/kg Q4W durvalumab + 1 mg/kg Q4W tremelimumab
    Arm type
    		 Experimental

    Investigational medicinal product name
    Danvatirsen (AZD9150)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3mg/kg QW (based on Ideal body weight determined using Devine formula) as IV infusion over 60 mintues.

    Investigational medicinal product name
    Tremelimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Tremelimumab 1 mg/kg Q4W as IV infusion over 60 mintues - for a total of 4 cycles (up to 4 doses)

    Investigational medicinal product name
    MEDI4736 (durvalumab)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    20 mg/kg Q4W as IV infusion over 60 mintues.

    Arm title
    		 A6C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg
    Arm description
    		 3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab
    Arm type
    		 Experimental

    Investigational medicinal product name
    Danvatirsen (AZD9150)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3mg/kg QW (based on Ideal body weight determined using Devine formula) as IV infusion over 60 mintues.

    Investigational medicinal product name
    MEDI4736 (durvalumab)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    20 mg/kg Q4W as IV infusion over 60 mintues.

    Arm title
    		 B1: AZD9150 3mg/kg + MEDI4736 20mg/kg Exp
    Arm description
    		 3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab
    Arm type
    		 Experimental

    Investigational medicinal product name
    MEDI4736 (durvalumab)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    20 mg/kg Q4W as IV infusion over 60 mintues.

    Investigational medicinal product name
    Danvatirsen (AZD9150)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3mg/kg QW (based on Ideal body weight determined using Devine formula) as IV infusion over 60 mintues.

    Arm title
    		 B2: AZD5069 40mg BID + MEDI4736 20mg/kg Exp
    Arm description
    		 40 mg BID AZD5069 (PO) + 20 mg/kg Q4W durvalumab
    Arm type
    		 Experimental

    Investigational medicinal product name
    MEDI4736 (durvalumab)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    20 mg/kg Q4W as IV infusion over 60 mintues.

    Investigational medicinal product name
    AZD5069
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg BID

    Arm title
    		 B3: AZD9150 3mg/kg + MEDI4736 20mg/kg Naive
    Arm description
    		 3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab
    Arm type
    		 Experimental

    Investigational medicinal product name
    MEDI4736 (durvalumab)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    20 mg/kg Q4W as IV infusion over 60 mintues.

    Investigational medicinal product name
    Danvatirsen (AZD9150)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3mg/kg QW (based on Ideal body weight determined using Devine formula) as IV infusion over 60 mintues.

    Arm title
    		 B4: AZD5069 40mg BID + MEDI4736 20mg/kg Naive
    Arm description
    		 40 mg BID AZD5069 (PO) + 20 mg/kg Q4W durvalumab
    Arm type
    		 Experimental

    Investigational medicinal product name
    MEDI4736 (durvalumab)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    20 mg/kg Q4W as IV infusion over 60 mintues.

    Investigational medicinal product name
    AZD5069
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg BID

    Arm title
    		 B5: AZD9150 3mg/kg
    Arm description
    		 3 mg/kg QW danvatirsen IV
    Arm type
    		 Experimental

    Investigational medicinal product name
    Danvatirsen (AZD9150)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3mg/kg QW (based on Ideal body weight determined using Devine formula) as IV infusion over 60 mintues.

    Arm title
    		 B6: AZD5069 40mg BID
    Arm description
    		 40 mg BID AZD5069 (PO)
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZD5069
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg BID

    Arm title
    		 B6a: AZD5069 40mg BID Fed/Fasted
    Arm description
    		 AZD5069 40mg BID (PO): Fed/Fasted
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZD5069
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg BID

    Arm title
    		 B6b: AZD5069 40mg BID Fasted/Fed
    Arm description
    		 AZD5069 40mg BID (PO): Fasted/Fed
    Arm type
    		 Experimental

    Investigational medicinal product name
    AZD5069
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg BID

    Arm title
    		 B7: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg
    Arm description
    		 3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab
    Arm type
    		 Experimental

    Investigational medicinal product name
    MEDI4736 (durvalumab)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    20 mg/kg Q4W as IV infusion over 60 mintues.

    Investigational medicinal product name
    Danvatirsen (AZD9150)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3mg/kg QW (based on Ideal body weight determined using Devine formula) as IV infusion over 60 mintues.

    Arm title
    		 B8: AZD9150 400mg q2w + MEDI4736 1.5g Q4W
    Arm description
    		 400 mg Q2W danvatirsen IV + 1.5 g Q4W durvalumab
    Arm type
    		 Experimental

    Investigational medicinal product name
    MEDI4736 (durvalumab)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1.5 gm Q4W as IV infusion over 60 mintues. If body weight decreases to less than 30 kg, weight-based dosing (20 mg/kg Q4W).

    Investigational medicinal product name
    Danvatirsen (AZD9150)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    400 mg Q2W as IV infusion over 60 mintues.

    Number of subjects in period 1
    		A1C1: AZD9150 2mg/kg + MEDI4736 20mg/kg A1C2: AZD9150 3mg/kg + MEDI4736 20mg/kg A2C1: AZD5069 40mg BID + MEDI4736 20mg/kg A2C2: AZD5069 80mg BID + MEDI4736 20mg/kg A3C1: AZD5069 80mg BID + MEDI4736 20mg/kg A4C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme A4C2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme A4C3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme A6C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg B1: AZD9150 3mg/kg + MEDI4736 20mg/kg Exp B2: AZD5069 40mg BID + MEDI4736 20mg/kg Exp B3: AZD9150 3mg/kg + MEDI4736 20mg/kg Naive B4: AZD5069 40mg BID + MEDI4736 20mg/kg Naive B5: AZD9150 3mg/kg B6: AZD5069 40mg BID B6a: AZD5069 40mg BID Fed/Fasted B6b: AZD5069 40mg BID Fasted/Fed B7: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg B8: AZD9150 400mg q2w + MEDI4736 1.5g Q4W
    Started
    4
    7
    10
    11
    15
    9
    7
    6
    14
    24
    20
    54
    25
    17
    10
    1
    1
    55
    50
    Completed
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Not completed
    4
    7
    10
    11
    15
    9
    7
    6
    14
    24
    20
    54
    25
    17
    10
    1
    1
    55
    49
         Adverse event, serious fatal
    -
    3
    3
    2
    4
    7
    3
    -
    2
    6
    6
    20
    9
    7
    3
    1
    1
    16
    5
         Consent withdrawn by subject
    1
    1
    5
    3
    5
    -
    -
    -
    2
    2
    -
    3
    7
    3
    1
    -
    -
    3
    -
         Adverse event, non-fatal
    1
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
         "Other"
    2
    2
    1
    3
    6
    2
    3
    4
    6
    16
    13
    31
    8
    7
    6
    -
    -
    34
    43
         Lost to follow-up
    -
    1
    1
    2
    -
    -
    -
    2
    3
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
         Disease Progression
    -
    -
    -
    -
    -
    -
    1
    -
    1
    -
    1
    -
    -
    -
    -
    -
    -
    2
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    A1C1: AZD9150 2mg/kg + MEDI4736 20mg/kg
    Reporting group description
    		 2mg/kg QW danvatirsen IV + 20mg/kg Q4W durvalumab

    Reporting group title
    A1C2: AZD9150 3mg/kg + MEDI4736 20mg/kg
    Reporting group description
    		 3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab

    Reporting group title
    A2C1: AZD5069 40mg BID + MEDI4736 20mg/kg
    Reporting group description
    		 40mg BID AZD5069 (PO) + 20mg/kg Q4W durvalumab

    Reporting group title
    A2C2: AZD5069 80mg BID + MEDI4736 20mg/kg
    Reporting group description
    		 80mg BID AZD5069 (PO) + 20mg/kg Q4W durvalumab

    Reporting group title
    A3C1: AZD5069 80mg BID + MEDI4736 20mg/kg
    Reporting group description
    		 80 mg BID AZD5069 (PO) with scheduled dose holds and titrations + 20 mg/kg Q4W durvalumab

    Reporting group title
    A4C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme
    Reporting group description
    		 3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab + 1 mg/kg Q4W tremelimumab

    Reporting group title
    A4C2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme
    Reporting group description
    		 2 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab + 1 mg/kg Q4W tremelimumab

    Reporting group title
    A4C3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme
    Reporting group description
    		 3 mg/kg Q2W danvatirsen IV + 20 mg/kg Q4W durvalumab + 1 mg/kg Q4W tremelimumab

    Reporting group title
    A6C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg
    Reporting group description
    		 3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab

    Reporting group title
    B1: AZD9150 3mg/kg + MEDI4736 20mg/kg Exp
    Reporting group description
    		 3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab

    Reporting group title
    B2: AZD5069 40mg BID + MEDI4736 20mg/kg Exp
    Reporting group description
    		 40 mg BID AZD5069 (PO) + 20 mg/kg Q4W durvalumab

    Reporting group title
    B3: AZD9150 3mg/kg + MEDI4736 20mg/kg Naive
    Reporting group description
    		 3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab

    Reporting group title
    B4: AZD5069 40mg BID + MEDI4736 20mg/kg Naive
    Reporting group description
    		 40 mg BID AZD5069 (PO) + 20 mg/kg Q4W durvalumab

    Reporting group title
    B5: AZD9150 3mg/kg
    Reporting group description
    		 3 mg/kg QW danvatirsen IV

    Reporting group title
    B6: AZD5069 40mg BID
    Reporting group description
    		 40 mg BID AZD5069 (PO)

    Reporting group title
    B6a: AZD5069 40mg BID Fed/Fasted
    Reporting group description
    		 AZD5069 40mg BID (PO): Fed/Fasted

    Reporting group title
    B6b: AZD5069 40mg BID Fasted/Fed
    Reporting group description
    		 AZD5069 40mg BID (PO): Fasted/Fed

    Reporting group title
    B7: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg
    Reporting group description
    		 3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab

    Reporting group title
    B8: AZD9150 400mg q2w + MEDI4736 1.5g Q4W
    Reporting group description
    		 400 mg Q2W danvatirsen IV + 1.5 g Q4W durvalumab

    Reporting group values
    		 A1C1: AZD9150 2mg/kg + MEDI4736 20mg/kg A1C2: AZD9150 3mg/kg + MEDI4736 20mg/kg A2C1: AZD5069 40mg BID + MEDI4736 20mg/kg A2C2: AZD5069 80mg BID + MEDI4736 20mg/kg A3C1: AZD5069 80mg BID + MEDI4736 20mg/kg A4C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme A4C2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme A4C3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme A6C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg B1: AZD9150 3mg/kg + MEDI4736 20mg/kg Exp B2: AZD5069 40mg BID + MEDI4736 20mg/kg Exp B3: AZD9150 3mg/kg + MEDI4736 20mg/kg Naive B4: AZD5069 40mg BID + MEDI4736 20mg/kg Naive B5: AZD9150 3mg/kg B6: AZD5069 40mg BID B6a: AZD5069 40mg BID Fed/Fasted B6b: AZD5069 40mg BID Fasted/Fed B7: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg B8: AZD9150 400mg q2w + MEDI4736 1.5g Q4W Total
    Number of subjects
    		 4 7 10 11 15 9 7 6 14 24 20 54 25 17 10 1 1 55 50 340
    Age categorical
    Age categorical variable
    Units: Subjects
        Adults (18-64 years)
    		 3 4 9 4 11 7 5 5 3 10 9 39 17 13 5 1 1 34 32 212
        Elderly (65-84 years)
    		 1 3 1 7 4 2 2 1 11 14 11 14 8 4 5 0 0 19 16 123
        Elderly 85 years and over
    		 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 2 2 5
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 55.8 ( 10.5 ) 64.1 ( 5.9 ) 55.3 ( 9.0 ) 64.5 ( 12.7 ) 59.7 ( 10.2 ) 53.4 ( 14.5 ) 57.0 ( 15.8 ) 54.0 ( 8.7 ) 69.3 ( 8.2 ) 65.5 ( 8.8 ) 64.8 ( 9.0 ) 61.5 ( 8.8 ) 61.1 ( 7.7 ) 60.6 ( 9.6 ) 61.4 ( 9.2 ) 64.0 ( 9999 ) 54.0 ( 9999 ) 63.0 ( 11.6 ) 62.3 ( 10.5 ) -
    Sex: Female, Male
    Units: Participants
        Male
    		 2 5 5 7 8 3 3 1 14 22 19 45 19 16 6 1 1 44 43 264
        Female
    		 2 2 5 4 7 6 4 5 0 2 1 9 6 1 4 0 0 11 7 76
    Race (NIH/OMB)
    Race categorical variable
    Units: Subjects
        White
    		 4 7 9 10 13 8 7 5 13 22 16 52 24 17 10 1 1 49 45 313
        Black or african american
    		 0 0 1 0 0 0 0 1 1 1 1 1 0 0 0 0 0 4 1 11
        Asian
    		 0 0 0 1 0 1 0 0 0 1 3 1 1 0 0 0 0 1 3 12
        Other
    		 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 1 1 4
    Subject analysis sets

    Subject analysis set title
    Part A1 Cohort 1: AZD9150 2mg/kg + MEDI4736 20mg/kg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients allocated in cohort of arm A1C1 (AZD9150/MEDI4736) will be evaluated for DLT until an MTD is achieved.

    Subject analysis set title
    Part A1 Cohort 2: AZD9150 3mg/kg + MEDI4736 20mg/kg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients allocated in cohort of arm A1C2 (AZD9150/MEDI4736) will be evaluated for DLT until an MTD is achieved.

    Subject analysis set title
    Part A2 Cohort 1: AZD5069 40mg BID + MEDI4736 20mg/kg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients allocated in cohort of arm A2C1 (AZD5069/MEDI4736) will be evaluated for DLT until an MTD is achieved.

    Subject analysis set title
    Part A2 Cohort 2: AZD5069 80mg BID + MEDI4736 20mg/kg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients allocated in cohort of arm A2C2 (AZD5069/MEDI4736) will be evaluated for DLT until an MTD is achieved.

    Subject analysis set title
    Part A3: AZD5069 80mg BID + MEDI4736 20mg/kg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients allocated in cohort of arm A3 (AZD5069/MEDI4736) will be evaluated for DLT and viability as alternate dosing option for Phase 2 studies

    Subject analysis set title
    Part A4 Cohort 1: AZD9150 3mg/kg q1w+MEDI4736 20mg/kg+Treme
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients allocated in cohort of arm A4C1 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD

    Subject analysis set title
    Part A4 Cohort 2: AZD9150 2mg/kg q1w+MEDI4736 20mg/kg+Treme
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients allocated in cohort of arm A4C2 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD

    Subject analysis set title
    Part A4 Cohort 3: AZD9150 3mg/kg q2w+MEDI4736 20mg/kg+Treme
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients allocated in cohort of arm A4C3 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD

    Subject analysis set title
    Part A6: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients allocated in cohort of arm A6 (AZD9150/MEDI4736) will be evaluated for safety, PK and PD.

    Subject analysis set title
    Part B1:AZD9150+MEDI4736:PDL1 pretreated
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients in arm B1 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.

    Subject analysis set title
    Part B2:AZD5069+MEDI4736:PDL1 pretreated
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients in arm B2 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.

    Subject analysis set title
    Part B3: AZD9150+MED4736:naiive 2L
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients in arm B3 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.

    Subject analysis set title
    Part B4:AZD5069+MEDI4736:naiive patients
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients in arm B4 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.

    Subject analysis set title
    Part B5: AZD9150 in naiive patients
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients in arm B5 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival

    Subject analysis set title
    Part B6:AZD5069 in naiive patients
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients in arm B6 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival

    Subject analysis set title
    Part B6a: AZD5069 40mg BID Fed/Fasted
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients in arm B6a will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival

    Subject analysis set title
    Part B6b: AZD5069 40mg BID Fasted/Fed
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients in arm B6b will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival

    Subject analysis set title
    Part B7: AZD9150+MEDI4736: naiive 1L
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients in Arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival

    Subject analysis set title
    Part B8: AZD9150 (every other week)+MEDI4736: naive 1L
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival

    Subject analysis set title
    Part A and B AZD9150 ADA Immunogenicity Population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All patients who received AZD9150 and provided at least one ADA sample

    Subject analysis set title
    Part A and B Durva ADA Immunogenicity Population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All patients who received Durva and provided at least one ADA smaple

    Subject analysis set title
    Part B1: AZD9150+MEDI4736:PDL1 pretreated (PD set)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients in arm B1 will be evaluated for efficacy until disease progression and then follow up for safety and survival

    Subject analysis set title
    Part B3: AZD9150+MEDI4736:naive 2L (PD set)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients in arm B3 will be evaluated for efficacy until disease progression and then followed up for safety and survival

    Subject analysis set title
    Part B5: AZD9150 in naive patients (PD set)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients in arm B5 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival

    Subject analysis set title
    Part B7: AZD9150+MEDI4736:naive 1L (PD set)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients in arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival

    Subject analysis set title
    Part B8: AZD9150 (every other week)+MEDI4736:naive 1L (PD set)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients in arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival

    Subject analysis set title
    Part B1:AZD9150+MEDI4736:PDL1 pretreated
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients in arm B1 will be evaluated for efficacy until disease progression and then followed up for safety and survival

    Subject analysis set title
    Part B2:AZD5069+MEDI4736:PDL1 pretreated
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients in arm B2 will be evaluated for efficacy until disease progression and then followed up for safety and survival

    Subject analysis set title
    Part B3:AZD9150+MEDI4736:naive 2L
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients in arm B3 will be evaluated for efficacy until disease progression and then followed up for safety and survival

    Subject analysis set title
    Part B4:AZD9150+MEDI4736:naive patients
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients in arm B4 will be evaluated for efficacy until disease progression and then followed up for safety and survival

    Subject analysis set title
    Part B7:AZD9150+MEDI4736:naive 1L
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients in arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival

    Subject analysis set title
    Part B8:AZD9150(every other week)+MEDi4736:naive 1L
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients in arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival

    Subject analysis sets values
    		 Part A1 Cohort 1: AZD9150 2mg/kg + MEDI4736 20mg/kg Part A1 Cohort 2: AZD9150 3mg/kg + MEDI4736 20mg/kg Part A2 Cohort 1: AZD5069 40mg BID + MEDI4736 20mg/kg Part A2 Cohort 2: AZD5069 80mg BID + MEDI4736 20mg/kg Part A3: AZD5069 80mg BID + MEDI4736 20mg/kg Part A4 Cohort 1: AZD9150 3mg/kg q1w+MEDI4736 20mg/kg+Treme Part A4 Cohort 2: AZD9150 2mg/kg q1w+MEDI4736 20mg/kg+Treme Part A4 Cohort 3: AZD9150 3mg/kg q2w+MEDI4736 20mg/kg+Treme Part A6: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg Part B1:AZD9150+MEDI4736:PDL1 pretreated Part B2:AZD5069+MEDI4736:PDL1 pretreated Part B3: AZD9150+MED4736:naiive 2L Part B4:AZD5069+MEDI4736:naiive patients Part B5: AZD9150 in naiive patients Part B6:AZD5069 in naiive patients Part B6a: AZD5069 40mg BID Fed/Fasted Part B6b: AZD5069 40mg BID Fasted/Fed Part B7: AZD9150+MEDI4736: naiive 1L Part B8: AZD9150 (every other week)+MEDI4736: naive 1L Part A and B AZD9150 ADA Immunogenicity Population Part A and B Durva ADA Immunogenicity Population Part B1: AZD9150+MEDI4736:PDL1 pretreated (PD set) Part B3: AZD9150+MEDI4736:naive 2L (PD set) Part B5: AZD9150 in naive patients (PD set) Part B7: AZD9150+MEDI4736:naive 1L (PD set) Part B8: AZD9150 (every other week)+MEDI4736:naive 1L (PD set) Part B1:AZD9150+MEDI4736:PDL1 pretreated Part B2:AZD5069+MEDI4736:PDL1 pretreated Part B3:AZD9150+MEDI4736:naive 2L Part B4:AZD9150+MEDI4736:naive patients Part B7:AZD9150+MEDI4736:naive 1L Part B8:AZD9150(every other week)+MEDi4736:naive 1L
    Number of subjects
    4
    7
    9
    11
    15
    9
    7
    6
    14
    24
    20
    53
    22
    14
    10
    1
    1
    55
    50
    247
    332
    8
    29
    5
    30
    34
    21
    18
    49
    21
    48
    36
    Age categorical
    Age categorical variable
    Units: Subjects
        Adults (18-64 years)
        Elderly (65-84 years)
        Elderly 85 years and over
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    55.8 ( 10.5 )
    64.1 ( 5.9 )
    55.3 ( 9.0 )
    64.5 ( 12.7 )
    59.7 ( 10.2 )
    53.4 ( 14.5 )
    57.0 ( 15.8 )
    54.0 ( 8.7 )
    69.3 ( 8.2 )
    65.5 ( 8.8 )
    64.8 ( 9.0 )
    61.5 ( 8.8 )
    61.1 ( 7.7 )
    60.6 ( 9.6 )
    54.0 ( 9.2 )
    64.0 ( 9999 )
    54.0 ( 9999 )
    63.0 ( 11.6 )
    62.3 ( 10.5 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Sex: Female, Male
    Units: Participants
        Male
    2
    5
    5
    7
    8
    3
    3
    1
    14
    22
    19
    45
    17
    14
    6
    1
    1
    44
    43
        Female
    2
    2
    4
    4
    7
    6
    4
    5
    0
    2
    1
    8
    5
    0
    4
    0
    0
    11
    7
    Race (NIH/OMB)
    Race categorical variable
    Units: Subjects
        White
    4
    7
    8
    10
    13
    8
    7
    5
    13
    22
    16
    51
    21
    14
    10
    1
    1
    49
    45
        Black or african american
    0
    0
    1
    0
    0
    0
    0
    1
    1
    1
    1
    1
    0
    0
    0
    0
    0
    4
    1
        Asian
    0
    0
    0
    1
    0
    1
    0
    0
    0
    1
    3
    1
    1
    0
    0
    0
    0
    1
    3
        Other
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    A1C1: AZD9150 2mg/kg + MEDI4736 20mg/kg
    Reporting group description
    		 2mg/kg QW danvatirsen IV + 20mg/kg Q4W durvalumab

    Reporting group title
    A1C2: AZD9150 3mg/kg + MEDI4736 20mg/kg
    Reporting group description
    		 3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab

    Reporting group title
    A2C1: AZD5069 40mg BID + MEDI4736 20mg/kg
    Reporting group description
    		 40mg BID AZD5069 (PO) + 20mg/kg Q4W durvalumab

    Reporting group title
    A2C2: AZD5069 80mg BID + MEDI4736 20mg/kg
    Reporting group description
    		 80mg BID AZD5069 (PO) + 20mg/kg Q4W durvalumab

    Reporting group title
    A3C1: AZD5069 80mg BID + MEDI4736 20mg/kg
    Reporting group description
    		 80 mg BID AZD5069 (PO) with scheduled dose holds and titrations + 20 mg/kg Q4W durvalumab

    Reporting group title
    A4C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme
    Reporting group description
    		 3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab + 1 mg/kg Q4W tremelimumab

    Reporting group title
    A4C2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme
    Reporting group description
    		 2 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab + 1 mg/kg Q4W tremelimumab

    Reporting group title
    A4C3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme
    Reporting group description
    		 3 mg/kg Q2W danvatirsen IV + 20 mg/kg Q4W durvalumab + 1 mg/kg Q4W tremelimumab

    Reporting group title
    A6C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg
    Reporting group description
    		 3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab

    Reporting group title
    B1: AZD9150 3mg/kg + MEDI4736 20mg/kg Exp
    Reporting group description
    		 3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab

    Reporting group title
    B2: AZD5069 40mg BID + MEDI4736 20mg/kg Exp
    Reporting group description
    		 40 mg BID AZD5069 (PO) + 20 mg/kg Q4W durvalumab

    Reporting group title
    B3: AZD9150 3mg/kg + MEDI4736 20mg/kg Naive
    Reporting group description
    		 3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab

    Reporting group title
    B4: AZD5069 40mg BID + MEDI4736 20mg/kg Naive
    Reporting group description
    		 40 mg BID AZD5069 (PO) + 20 mg/kg Q4W durvalumab

    Reporting group title
    B5: AZD9150 3mg/kg
    Reporting group description
    		 3 mg/kg QW danvatirsen IV

    Reporting group title
    B6: AZD5069 40mg BID
    Reporting group description
    		 40 mg BID AZD5069 (PO)

    Reporting group title
    B6a: AZD5069 40mg BID Fed/Fasted
    Reporting group description
    		 AZD5069 40mg BID (PO): Fed/Fasted

    Reporting group title
    B6b: AZD5069 40mg BID Fasted/Fed
    Reporting group description
    		 AZD5069 40mg BID (PO): Fasted/Fed

    Reporting group title
    B7: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg
    Reporting group description
    		 3 mg/kg QW danvatirsen IV + 20 mg/kg Q4W durvalumab

    Reporting group title
    B8: AZD9150 400mg q2w + MEDI4736 1.5g Q4W
    Reporting group description
    		 400 mg Q2W danvatirsen IV + 1.5 g Q4W durvalumab

    Subject analysis set title
    Part A1 Cohort 1: AZD9150 2mg/kg + MEDI4736 20mg/kg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients allocated in cohort of arm A1C1 (AZD9150/MEDI4736) will be evaluated for DLT until an MTD is achieved.

    Subject analysis set title
    Part A1 Cohort 2: AZD9150 3mg/kg + MEDI4736 20mg/kg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients allocated in cohort of arm A1C2 (AZD9150/MEDI4736) will be evaluated for DLT until an MTD is achieved.

    Subject analysis set title
    Part A2 Cohort 1: AZD5069 40mg BID + MEDI4736 20mg/kg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients allocated in cohort of arm A2C1 (AZD5069/MEDI4736) will be evaluated for DLT until an MTD is achieved.

    Subject analysis set title
    Part A2 Cohort 2: AZD5069 80mg BID + MEDI4736 20mg/kg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients allocated in cohort of arm A2C2 (AZD5069/MEDI4736) will be evaluated for DLT until an MTD is achieved.

    Subject analysis set title
    Part A3: AZD5069 80mg BID + MEDI4736 20mg/kg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients allocated in cohort of arm A3 (AZD5069/MEDI4736) will be evaluated for DLT and viability as alternate dosing option for Phase 2 studies

    Subject analysis set title
    Part A4 Cohort 1: AZD9150 3mg/kg q1w+MEDI4736 20mg/kg+Treme
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients allocated in cohort of arm A4C1 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD

    Subject analysis set title
    Part A4 Cohort 2: AZD9150 2mg/kg q1w+MEDI4736 20mg/kg+Treme
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients allocated in cohort of arm A4C2 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD

    Subject analysis set title
    Part A4 Cohort 3: AZD9150 3mg/kg q2w+MEDI4736 20mg/kg+Treme
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients allocated in cohort of arm A4C3 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD

    Subject analysis set title
    Part A6: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients allocated in cohort of arm A6 (AZD9150/MEDI4736) will be evaluated for safety, PK and PD.

    Subject analysis set title
    Part B1:AZD9150+MEDI4736:PDL1 pretreated
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients in arm B1 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.

    Subject analysis set title
    Part B2:AZD5069+MEDI4736:PDL1 pretreated
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients in arm B2 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.

    Subject analysis set title
    Part B3: AZD9150+MED4736:naiive 2L
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients in arm B3 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.

    Subject analysis set title
    Part B4:AZD5069+MEDI4736:naiive patients
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients in arm B4 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.

    Subject analysis set title
    Part B5: AZD9150 in naiive patients
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients in arm B5 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival

    Subject analysis set title
    Part B6:AZD5069 in naiive patients
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients in arm B6 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival

    Subject analysis set title
    Part B6a: AZD5069 40mg BID Fed/Fasted
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients in arm B6a will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival

    Subject analysis set title
    Part B6b: AZD5069 40mg BID Fasted/Fed
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients in arm B6b will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival

    Subject analysis set title
    Part B7: AZD9150+MEDI4736: naiive 1L
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients in Arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival

    Subject analysis set title
    Part B8: AZD9150 (every other week)+MEDI4736: naive 1L
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival

    Subject analysis set title
    Part A and B AZD9150 ADA Immunogenicity Population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All patients who received AZD9150 and provided at least one ADA sample

    Subject analysis set title
    Part A and B Durva ADA Immunogenicity Population
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All patients who received Durva and provided at least one ADA smaple

    Subject analysis set title
    Part B1: AZD9150+MEDI4736:PDL1 pretreated (PD set)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients in arm B1 will be evaluated for efficacy until disease progression and then follow up for safety and survival

    Subject analysis set title
    Part B3: AZD9150+MEDI4736:naive 2L (PD set)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients in arm B3 will be evaluated for efficacy until disease progression and then followed up for safety and survival

    Subject analysis set title
    Part B5: AZD9150 in naive patients (PD set)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients in arm B5 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival

    Subject analysis set title
    Part B7: AZD9150+MEDI4736:naive 1L (PD set)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients in arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival

    Subject analysis set title
    Part B8: AZD9150 (every other week)+MEDI4736:naive 1L (PD set)
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients in arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival

    Subject analysis set title
    Part B1:AZD9150+MEDI4736:PDL1 pretreated
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients in arm B1 will be evaluated for efficacy until disease progression and then followed up for safety and survival

    Subject analysis set title
    Part B2:AZD5069+MEDI4736:PDL1 pretreated
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients in arm B2 will be evaluated for efficacy until disease progression and then followed up for safety and survival

    Subject analysis set title
    Part B3:AZD9150+MEDI4736:naive 2L
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients in arm B3 will be evaluated for efficacy until disease progression and then followed up for safety and survival

    Subject analysis set title
    Part B4:AZD9150+MEDI4736:naive patients
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients in arm B4 will be evaluated for efficacy until disease progression and then followed up for safety and survival

    Subject analysis set title
    Part B7:AZD9150+MEDI4736:naive 1L
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients in arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival

    Subject analysis set title
    Part B8:AZD9150(every other week)+MEDi4736:naive 1L
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients in arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival

    Primary: Part A: Danvatirsen With Durvalumab MTDs (Maximum Tolerated Dose) or recommended doses for dose-expansion

    		 Close Top of page
    End point title
    		 Part A: Danvatirsen With Durvalumab MTDs (Maximum Tolerated Dose) or recommended doses for dose-expansion [1]
    End point description
    After completion of DLT period (35 days) for the maximum dose cohort. A CRM–based approach was used to identify the set of dose combinations where the incidence of DLT was ≤ 33%. The dose with expected DLT incidence closest and below 0.33 at this point was the “model estimated” MTD. During trial execution, the Safety Review Committee (SRC) determined the MTD.
    End point type
    Primary
    End point timeframe
    35 days
    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: Only descriptive stats are provided for early phase trials. No formal statistical analyses were performed on primary endpoints.
    End point values
    		 Part A1 Cohort 1: AZD9150 2mg/kg + MEDI4736 20mg/kg Part A1 Cohort 2: AZD9150 3mg/kg + MEDI4736 20mg/kg Part A4 Cohort 1: AZD9150 3mg/kg q1w+MEDI4736 20mg/kg+Treme Part A4 Cohort 2: AZD9150 2mg/kg q1w+MEDI4736 20mg/kg+Treme Part A4 Cohort 3: AZD9150 3mg/kg q2w+MEDI4736 20mg/kg+Treme Part A6: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg
    Number of subjects analysed
    4
    7
    9
    7
    6
    14
    Units: mg/kg
    2
    3
    3
    2
    3
    3
    No statistical analyses for this end point

    Primary: Part A: AZD5069 With Durvalumab MTDs (Maximum Tolerated Dose) or recommended doses for dose-expansion

    		 Close Top of page
    End point title
    		 Part A: AZD5069 With Durvalumab MTDs (Maximum Tolerated Dose) or recommended doses for dose-expansion [2]
    End point description
    After completion of DLT period (35 days) for the maximum dose cohort. A CRM–based approach was used to identify the set of dose combinations where the incidence of DLT was ≤ 33%. The dose with expected DLT incidence closest and below 0.33 at this point was the “model estimated” MTD. During trial execution, the Safety Review Committee (SRC) determined the MTD.
    End point type
    Primary
    End point timeframe
    35 days
    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: Only descriptive stats are provided for early phase trials. No formal statistical analyses were performed on primary endpoints.
    End point values
    		 Part A2 Cohort 1: AZD5069 40mg BID + MEDI4736 20mg/kg Part A2 Cohort 2: AZD5069 80mg BID + MEDI4736 20mg/kg Part A3: AZD5069 80mg BID + MEDI4736 20mg/kg
    Number of subjects analysed
    10
    11
    15
    Units: mg
    40
    80
    80
    No statistical analyses for this end point

    Primary: Part A: safety and tolerability in terms of adverse events

    		 Close Top of page
    End point title
    		 Part A: safety and tolerability in terms of adverse events [3]
    End point description
    Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters
    End point type
    Primary
    End point timeframe
    At every treatment and follow up visit until disease progression, an average of 1 year.
    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: Only descriptive stats are provided for early phase trials. No formal statistical analyses were performed on primary endpoints.
    End point values
    		 Part A1 Cohort 1: AZD9150 2mg/kg + MEDI4736 20mg/kg Part A1 Cohort 2: AZD9150 3mg/kg + MEDI4736 20mg/kg Part A2 Cohort 2: AZD5069 80mg BID + MEDI4736 20mg/kg Part A3: AZD5069 80mg BID + MEDI4736 20mg/kg Part A4 Cohort 1: AZD9150 3mg/kg q1w+MEDI4736 20mg/kg+Treme Part A4 Cohort 2: AZD9150 2mg/kg q1w+MEDI4736 20mg/kg+Treme Part A4 Cohort 3: AZD9150 3mg/kg q2w+MEDI4736 20mg/kg+Treme Part A6: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg
    Number of subjects analysed
    4
    7
    11
    15
    9
    7
    6
    14
    Units: Patients
    4
    7
    10
    15
    9
    7
    5
    14
    No statistical analyses for this end point

    Primary: Part B: ORR (Objective Response Rate) in patients with IL/2L RM-SCCHN.

    		 Close Top of page
    End point title
    		 Part B: ORR (Objective Response Rate) in patients with IL/2L RM-SCCHN. [4]
    End point description
    proportion of patients who have an objective response at a given visit. ORR will be summarised by treatment group. Objective rate is defined as a CR or PR according to RECIST 1.1.
    End point type
    Primary
    End point timeframe
    Assessed at every even-numbered cycles with RECIST until disease progression, up to 12 months.
    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: Only descriptive stats are provided for early phase trials. No formal statistical analyses were performed on primary endpoints.
    End point values
    		 Part B1:AZD9150+MEDI4736:PDL1 pretreated Part B2:AZD5069+MEDI4736:PDL1 pretreated Part B3: AZD9150+MED4736:naiive 2L Part B4:AZD5069+MEDI4736:naiive patients Part B7: AZD9150+MEDI4736: naiive 1L Part B8: AZD9150 (every other week)+MEDI4736: naive 1L
    Number of subjects analysed
    24
    20
    53
    22
    55
    50
    Units: percentage of participants
        number (confidence interval 95%)
    4.2 (0.11 to 21.12)
    10.0 (1.23 to 31.70)
    22.6 (12.28 to 36.21)
    4.5 (0.12 to 22.84)
    21.8 (11.81 to 35.01)
    26.0 (14.63 to 40.34)
    No statistical analyses for this end point

    Secondary: Part A and B: AZD9150 AUC0-6h at lead in day-7

    		 Close Top of page
    End point title
    		 Part A and B: AZD9150 AUC0-6h at lead in day-7
    End point description
    If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to calculate AUC, we need to have enough PK samples collected to enable AUC estimation. That is why we have a difference in actual AUC calculated number of subjects vs number of subjects participated.
    End point type
    Secondary
    End point timeframe
    Lead in day -7, AUC from time 0 to 6h (post dose).
    End point values
    		 Part A1 Cohort 1: AZD9150 2mg/kg + MEDI4736 20mg/kg Part A1 Cohort 2: AZD9150 3mg/kg + MEDI4736 20mg/kg Part A4 Cohort 1: AZD9150 3mg/kg q1w+MEDI4736 20mg/kg+Treme Part A4 Cohort 2: AZD9150 2mg/kg q1w+MEDI4736 20mg/kg+Treme Part A4 Cohort 3: AZD9150 3mg/kg q2w+MEDI4736 20mg/kg+Treme Part A6: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg Part B3: AZD9150+MED4736:naiive 2L
    Number of subjects analysed
    4
    7
    9
    7
    6
    14
    53
    Units: ng.h/ml
        geometric mean (geometric coefficient of variation)
    38860 ( 17.31 )
    60260 ( 14.29 )
    55960 ( 14.72 )
    36580 ( 14.75 )
    47080 ( 13.10 )
    57780 ( 23.16 )
    54290 ( 17.41 )
    No statistical analyses for this end point

    Secondary: Part A and B: AZD9150 Cmax at lead in day -7

    		 Close Top of page
    End point title
    		 Part A and B: AZD9150 Cmax at lead in day -7
    End point description
    If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to estimate Cmax we need to have samples at end of infusion, which was not available for all the subjects in PK analysis set. That is why there is a difference between Cmax calculated number of subjects vs number of subjects participated.
    End point type
    Secondary
    End point timeframe
    Lead in day -7
    End point values
    		 Part A1 Cohort 1: AZD9150 2mg/kg + MEDI4736 20mg/kg Part A1 Cohort 2: AZD9150 3mg/kg + MEDI4736 20mg/kg Part A4 Cohort 1: AZD9150 3mg/kg q1w+MEDI4736 20mg/kg+Treme Part A4 Cohort 2: AZD9150 2mg/kg q1w+MEDI4736 20mg/kg+Treme Part A4 Cohort 3: AZD9150 3mg/kg q2w+MEDI4736 20mg/kg+Treme Part A6: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg Part B3: AZD9150+MED4736:naiive 2L Part B8: AZD9150 (every other week)+MEDI4736: naive 1L
    Number of subjects analysed
    4
    7
    9
    7
    6
    14
    53
    50
    Units: ng/ml
        geometric mean (geometric coefficient of variation)
    21800 ( 16.76 )
    30680 ( 16.31 )
    27570 ( 13.21 )
    18200 ( 24.82 )
    23860 ( 16.10 )
    27230 ( 21.54 )
    23890 ( 23.48 )
    25430 ( 30.23 )
    No statistical analyses for this end point

    Secondary: Part A and B: AZD9150 AUC0-6h at Cycle 2 day 1

    		 Close Top of page
    End point title
    		 Part A and B: AZD9150 AUC0-6h at Cycle 2 day 1
    End point description
    If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to calculate AUC, we need to have enough PK samples collected to enable AUC estimation. That is why we have a difference in actual AUC calculated number of subjects vs number of subjects participated.
    End point type
    Secondary
    End point timeframe
    Cycle 2 day 1, AUC from time 0 to 6 h post dose
    End point values
    		 Part A1 Cohort 2: AZD9150 3mg/kg + MEDI4736 20mg/kg Part A4 Cohort 1: AZD9150 3mg/kg q1w+MEDI4736 20mg/kg+Treme Part A4 Cohort 3: AZD9150 3mg/kg q2w+MEDI4736 20mg/kg+Treme Part A6: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg Part B3: AZD9150+MED4736:naiive 2L
    Number of subjects analysed
    7
    9
    6
    14
    53
    Units: ng.h/ml
        geometric mean (geometric coefficient of variation)
    61810 ( 22.57 )
    53480 ( 23.10 )
    44300 ( 11.64 )
    51690 ( 20.72 )
    62020 ( 18.43 )
    No statistical analyses for this end point

    Secondary: Part A and B: AZD9150 Cmax at cycle 2 day 1

    		 Close Top of page
    End point title
    		 Part A and B: AZD9150 Cmax at cycle 2 day 1
    End point description
    End point type
    Secondary
    End point timeframe
    Cycle 2 day 1
    End point values
    		 Part A1 Cohort 2: AZD9150 3mg/kg + MEDI4736 20mg/kg Part A4 Cohort 1: AZD9150 3mg/kg q1w+MEDI4736 20mg/kg+Treme Part A4 Cohort 2: AZD9150 2mg/kg q1w+MEDI4736 20mg/kg+Treme Part A4 Cohort 3: AZD9150 3mg/kg q2w+MEDI4736 20mg/kg+Treme Part A6: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg Part B3: AZD9150+MED4736:naiive 2L Part B8: AZD9150 (every other week)+MEDI4736: naive 1L
    Number of subjects analysed
    7
    9
    7
    6
    14
    53
    50
    Units: ng/ml
        geometric mean (geometric coefficient of variation)
    30090 ( 24.35 )
    26870 ( 26.66 )
    14990 ( 11.56 )
    22100 ( 18.12 )
    23820 ( 25.72 )
    28030 ( 10.75 )
    48540 ( 26.87 )
    No statistical analyses for this end point

    Secondary: Part A and B: AZD5069 AUC0-12h at lead in day -7

    		 Close Top of page
    End point title
    		 Part A and B: AZD5069 AUC0-12h at lead in day -7
    End point description
    If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to calculate AUC, we need to have enough PK samples collected to enable AUC estimation. That is why we have a difference in actual AUC calculated number of subjects vs number of subjects participated.
    End point type
    Secondary
    End point timeframe
    Lead in day -7, AUC from time 0 to 12h post dose
    End point values
    		 Part A2 Cohort 2: AZD5069 80mg BID + MEDI4736 20mg/kg Part A3: AZD5069 80mg BID + MEDI4736 20mg/kg
    Number of subjects analysed
    11
    15
    Units: nM.h/L
        geometric mean (geometric coefficient of variation)
    17490 ( 37.71 )
    17810 ( 37.46 )
    No statistical analyses for this end point

    Secondary: Part A and B: AZD5069 Cmax at lead in day -7

    		 Close Top of page
    End point title
    		 Part A and B: AZD5069 Cmax at lead in day -7
    End point description
    If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to estimate Cmax we need to have samples at Tmax, which was not available for all the subjects in PK analysis set. That is why there is a difference between Cmax calculated number of subjects vs number of subjects participated.
    End point type
    Secondary
    End point timeframe
    Lead in day -7
    End point values
    		 Part A2 Cohort 2: AZD5069 80mg BID + MEDI4736 20mg/kg Part A3: AZD5069 80mg BID + MEDI4736 20mg/kg
    Number of subjects analysed
    11
    15
    Units: nM/L
        geometric mean (geometric coefficient of variation)
    3278 ( 46.17 )
    3852 ( 45.13 )
    No statistical analyses for this end point

    Secondary: Part A and B: AZD5069 Cssmax at cycle 2 day 1

    		 Close Top of page
    End point title
    		 Part A and B: AZD5069 Cssmax at cycle 2 day 1
    End point description
    If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to estimate Cmax we need to have samples at around Tmax, which was not available for all the subjects in PK analysis set. That is why there is a difference between Cmax calculated number of subjects vs number of subjects participated.
    End point type
    Secondary
    End point timeframe
    Cycle 2 day 1
    End point values
    		 Part A2 Cohort 2: AZD5069 80mg BID + MEDI4736 20mg/kg Part A3: AZD5069 80mg BID + MEDI4736 20mg/kg Part B4:AZD5069+MEDI4736:naiive patients Part B6:AZD5069 in naiive patients
    Number of subjects analysed
    11
    15
    22
    1
    Units: nM/L
        geometric mean (geometric coefficient of variation)
    4195 ( 30.36 )
    4692 ( 29.12 )
    3336 ( 23.34 )
    9999 ( 9999 )
    No statistical analyses for this end point

    Secondary: Part A and B: AZD5069 AUCss at cycle 2 day 1

    		 Close Top of page
    End point title
    		 Part A and B: AZD5069 AUCss at cycle 2 day 1
    End point description
    If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to calculate AUC, we need to have enough PK samples collected to enable AUC estimation. That is why we have a difference in actual AUC calculated number of subjects vs number of subjects participated.
    End point type
    Secondary
    End point timeframe
    Cycle 2 day 1
    End point values
    		 Part A2 Cohort 2: AZD5069 80mg BID + MEDI4736 20mg/kg Part A3: AZD5069 80mg BID + MEDI4736 20mg/kg Part B6:AZD5069 in naiive patients
    Number of subjects analysed
    11
    15
    1
    Units: nM.h/L
        geometric mean (geometric coefficient of variation)
    25500 ( 21.40 )
    22020 ( 37.13 )
    9999 ( 9999 )
    No statistical analyses for this end point

    Secondary: Part A and B: Durvalumab Cmax after single dose at Cycle 1 day 1

    		 Close Top of page
    End point title
    		 Part A and B: Durvalumab Cmax after single dose at Cycle 1 day 1
    End point description
    End point type
    Secondary
    End point timeframe
    Cycle 1 day 1
    End point values
    		 Part A4 Cohort 3: AZD9150 3mg/kg q2w+MEDI4736 20mg/kg+Treme Part B8: AZD9150 (every other week)+MEDI4736: naive 1L
    Number of subjects analysed
    6
    50
    Units: ug/ml
        geometric mean (geometric coefficient of variation)
    499.3 ( 32.28 )
    409.4 ( 74.66 )
    No statistical analyses for this end point

    Secondary: Part A and B: Durvalumab Ctrough after multiple doses at Cycle 4 day 1

    		 Close Top of page
    End point title
    		 Part A and B: Durvalumab Ctrough after multiple doses at Cycle 4 day 1
    End point description
    If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to estimate Ctrough we need to have samples at predose, which was not available for all the subjects in PK analysis set. That is why there is a difference between Ctrough calculated number of subjects vs number of subjects participated.
    End point type
    Secondary
    End point timeframe
    Cycle 4 day 1
    End point values
    		 Part A4 Cohort 3: AZD9150 3mg/kg q2w+MEDI4736 20mg/kg+Treme Part A6: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg Part B7: AZD9150+MEDI4736: naiive 1L Part B8: AZD9150 (every other week)+MEDI4736: naive 1L
    Number of subjects analysed
    6
    14
    55
    50
    Units: ug/ml
        geometric mean (geometric coefficient of variation)
    100.6 ( 52.48 )
    148.7 ( 22.38 )
    107.1 ( 60.94 )
    120.6 ( 31.85 )
    No statistical analyses for this end point

    Secondary: Part A and B: Durvalumab Cmax after multiple doses at Cycle 8 day 1

    		 Close Top of page
    End point title
    		 Part A and B: Durvalumab Cmax after multiple doses at Cycle 8 day 1
    End point description
    If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to estimate Cmax we need to have samples at end of infusion, which was not available for all the subjects in PK analysis set. That is why there is a difference between Cmax calculated number of subjects vs number of subjects participated.
    End point type
    Secondary
    End point timeframe
    Cycle 8 day 1
    End point values
    		 Part B7: AZD9150+MEDI4736: naiive 1L Part B8: AZD9150 (every other week)+MEDI4736: naive 1L
    Number of subjects analysed
    55
    50
    Units: ug/ml
        geometric mean (geometric coefficient of variation)
    107.1 ( 60.94 )
    120.6 ( 31.85 )
    No statistical analyses for this end point

    Secondary: Part A and B: Treme Cmax after single dose

    		 Close Top of page
    End point title
    		 Part A and B: Treme Cmax after single dose
    End point description
    If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to estimate Cmax we need to have samples at end of infusion, which was not available for all the subjects in PK analysis set. That is why there is a difference between Cmax calculated number of subjects vs number of subjects participated.
    End point type
    Secondary
    End point timeframe
    Cycle 1 day 1
    End point values
    		 Part A4 Cohort 1: AZD9150 3mg/kg q1w+MEDI4736 20mg/kg+Treme Part A4 Cohort 2: AZD9150 2mg/kg q1w+MEDI4736 20mg/kg+Treme Part A4 Cohort 3: AZD9150 3mg/kg q2w+MEDI4736 20mg/kg+Treme
    Number of subjects analysed
    9
    7
    6
    Units: ng/ml
        geometric mean (geometric coefficient of variation)
    23840 ( 23.39 )
    20260 ( 17.71 )
    21290 ( 20.67 )
    No statistical analyses for this end point

    Secondary: Part A and B: Treme Ctrough after multiple doses at cycle 4 day 1

    		 Close Top of page
    End point title
    		 Part A and B: Treme Ctrough after multiple doses at cycle 4 day 1
    End point description
    If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to estimate Ctrough we need to have samples at predose, which was not available for all the subjects in PK analysis set. That is why there is a difference between Ctrough calculated number of subjects vs number of subjects participated.
    End point type
    Secondary
    End point timeframe
    Cycle 4 day 1
    End point values
    		 Part A4 Cohort 3: AZD9150 3mg/kg q2w+MEDI4736 20mg/kg+Treme
    Number of subjects analysed
    6
    Units: ng/ml
        geometric mean (geometric coefficient of variation)
    2999 ( 9.780 )
    No statistical analyses for this end point

    Secondary: Part A and B: Immunogenecity as percent of ADA positive subjects

    		 Close Top of page
    End point title
    		 Part A and B: Immunogenecity as percent of ADA positive subjects
    End point description
    Subject was considered ADA positive if any post dose samples had ADA positive result. Result was not stratified based on post dose time points.
    End point type
    Secondary
    End point timeframe
    Throughout the study, up to 3.3 years
    End point values
    		 Part A and B AZD9150 ADA Immunogenicity Population Part A and B Durva ADA Immunogenicity Population
    Number of subjects analysed
    247
    440
    Units: % of total analyzed patient
        number (not applicable)
    2.8
    5
    No statistical analyses for this end point

    Secondary: Part A: Antitumour activity in monotherapy and combination arms of study

    		 Close Top of page
    End point title
    		 Part A: Antitumour activity in monotherapy and combination arms of study
    End point description
    complete response, partial response, stable disease or progressive disease based on RECIST
    End point type
    Secondary
    End point timeframe
    assessed at every even numbered cycle with RECIST until disease progression, an average of 1 year
    End point values
    		 Part A1 Cohort 1: AZD9150 2mg/kg + MEDI4736 20mg/kg Part A1 Cohort 2: AZD9150 3mg/kg + MEDI4736 20mg/kg Part A2 Cohort 2: AZD5069 80mg BID + MEDI4736 20mg/kg Part A3: AZD5069 80mg BID + MEDI4736 20mg/kg Part A4 Cohort 1: AZD9150 3mg/kg q1w+MEDI4736 20mg/kg+Treme Part A4 Cohort 2: AZD9150 2mg/kg q1w+MEDI4736 20mg/kg+Treme Part A4 Cohort 3: AZD9150 3mg/kg q2w+MEDI4736 20mg/kg+Treme
    Number of subjects analysed
    4
    7
    11
    15
    9
    7
    6
    Units: Number of Patients
        Complete response
    0
    0
    1
    0
    0
    0
    0
        Partial response
    1
    1
    0
    0
    1
    0
    1
        Stable disease
    1
    3
    5
    3
    2
    2
    2
        Progression
    2
    3
    4
    9
    6
    5
    1
    No statistical analyses for this end point

    Secondary: Part B: safety and tolerability in terms of adverse events

    		 Close Top of page
    End point title
    		 Part B: safety and tolerability in terms of adverse events
    End point description
    Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters
    End point type
    Secondary
    End point timeframe
    At every treatment and follow up visit until disease progression, an average of 1 year.
    End point values
    		 Part B1:AZD9150+MEDI4736:PDL1 pretreated Part B2:AZD5069+MEDI4736:PDL1 pretreated Part B3: AZD9150+MED4736:naiive 2L Part B4:AZD5069+MEDI4736:naiive patients Part B5: AZD9150 in naiive patients Part B6a: AZD5069 40mg BID Fed/Fasted Part B6b: AZD5069 40mg BID Fasted/Fed Part B7: AZD9150+MEDI4736: naiive 1L Part B8: AZD9150 (every other week)+MEDI4736: naive 1L
    Number of subjects analysed
    24
    20
    53
    22
    14
    1
    1
    55
    50
    Units: Patients
    22
    19
    51
    20
    14
    1
    1
    55
    48
    No statistical analyses for this end point

    Secondary: Part B: Secondary measures change in efficacy - Disease control rate

    		 Close Top of page
    End point title
    		 Part B: Secondary measures change in efficacy - Disease control rate
    End point description
    Disease control rate is confirmed complete response (CR), confirmed partial response (PR) and stable disease (SD)
    End point type
    Secondary
    End point timeframe
    Assessed at every even-numbered cycles. Assessed at every even numbered cycle with RECIST until disease progression, up to 12 months
    End point values
    		 Part B1:AZD9150+MEDI4736:PDL1 pretreated Part B2:AZD5069+MEDI4736:PDL1 pretreated Part B3: AZD9150+MED4736:naiive 2L Part B4:AZD5069+MEDI4736:naiive patients Part B5: AZD9150 in naiive patients Part B7: AZD9150+MEDI4736: naiive 1L Part B8: AZD9150 (every other week)+MEDI4736: naive 1L
    Number of subjects analysed
    24
    20
    53
    22
    14
    55
    50
    Units: Percentage of participants
        number (confidence interval 80%)
    20.8 (10.50 to 35.25)
    20.0 (9.02 to 36.07)
    37.7 (28.75 to 47.45)
    18.2 (8.17 to 33.10)
    28.6 (13.09 to 49.20)
    32.7 (24.32 to 42.13)
    44.0 (34.34 to 54.04)
    No statistical analyses for this end point

    Secondary: Part B: Secondary measures change in efficacy - Duration of overall response

    		 Close Top of page
    End point title
    		 Part B: Secondary measures change in efficacy - Duration of overall response
    End point description
    Duration of overall response is according to RECIST 1.1 criteria measured from the time measurement criteria are first met for CR or PR, whichever is first recorded, until the first date that recurrent or PD is objectively documented (taking as reference for PD the smallest measurements recorded on study). DOR is only applied to treatment groups where at least one response patient was recorded.
    End point type
    Secondary
    End point timeframe
    Assessed at every even-numbered cycles. Assessed at every even numbered cycle with RECIST until disease progression, up to 48 months
    End point values
    		 Part B1:AZD9150+MEDI4736:PDL1 pretreated Part B2:AZD5069+MEDI4736:PDL1 pretreated Part B3: AZD9150+MED4736:naiive 2L Part B4:AZD5069+MEDI4736:naiive patients Part B7: AZD9150+MEDI4736: naiive 1L Part B8: AZD9150 (every other week)+MEDI4736: naive 1L
    Number of subjects analysed
    24
    20
    53
    22
    55
    50
    Units: Weeks
        median (full range (min-max))
    165.9 (165.9 to 165.9)
    29.0 (16.3 to 41.7)
    66.0 (13.4 to 172.0)
    37.0 (37.0 to 37.0)
    48.6 (23.3 to 110.1)
    27.57 (13.7 to 37.1)
    No statistical analyses for this end point

    Secondary: Part B: Secondary measures change in efficacy - PFS

    		 Close Top of page
    End point title
    		 Part B: Secondary measures change in efficacy - PFS
    End point description
    progression-free survival (PFS): defined as the time from randomisation to the first documentation of PD as determined by the Investigator or death from any cause, whichever occurs first. Only includes progression events that occur within 126 days of the last evaluable assessment
    End point type
    Secondary
    End point timeframe
    Assessed at every even-numbered cycles. Assessed at every even numbered cycle with RECIST until disease progression, up to 12 months
    End point values
    		 Part B1:AZD9150+MEDI4736:PDL1 pretreated Part B2:AZD5069+MEDI4736:PDL1 pretreated Part B3: AZD9150+MED4736:naiive 2L Part B4:AZD5069+MEDI4736:naiive patients Part B5: AZD9150 in naiive patients Part B6a: AZD5069 40mg BID Fed/Fasted Part B6b: AZD5069 40mg BID Fasted/Fed Part B7: AZD9150+MEDI4736: naiive 1L Part B8: AZD9150 (every other week)+MEDI4736: naive 1L
    Number of subjects analysed
    24
    20
    53
    22
    14
    1
    1
    55
    50
    Units: Days
        median (confidence interval 80%)
    51.0 (40.00 to 95.00)
    51.0 (50.00 to 92.00)
    66.5 (50.00 to 103.00)
    52.00 (48.00 to 89.00)
    47.0 (47.00 to 64.00)
    47.0 (-9999 to 9999)
    51.0 (-9999 to 9999)
    85.0 (58.00 to 96.00)
    104.0 (92.00 to 178.00)
    No statistical analyses for this end point

    Secondary: Part B: Secondary measures change in efficacy - OS

    		 Close Top of page
    End point title
    		 Part B: Secondary measures change in efficacy - OS
    End point description
    overall survival (OS) – defined as the time from treatment allocation to death from any cause
    End point type
    Secondary
    End point timeframe
    Assessed at every even-numbered cycles. Assessed at every even numbered cycle with RECIST until disease progression, up to 15 months
    End point values
    		 Part B1:AZD9150+MEDI4736:PDL1 pretreated Part B2:AZD5069+MEDI4736:PDL1 pretreated Part B3: AZD9150+MED4736:naiive 2L Part B4:AZD5069+MEDI4736:naiive patients Part B5: AZD9150 in naiive patients Part B6a: AZD5069 40mg BID Fed/Fasted Part B6b: AZD5069 40mg BID Fasted/Fed Part B7: AZD9150+MEDI4736: naiive 1L Part B8: AZD9150 (every other week)+MEDI4736: naive 1L
    Number of subjects analysed
    24
    20
    53
    22
    14
    1
    1
    55
    50
    Units: Days
        median (confidence interval 80%)
    203.0 (152.0 to 290.0)
    288.0 (198.0 to 539.0)
    199.0 (126.0 to 351.0)
    254.0 (202.0 to 427.0)
    175.0 (114.0 to 196.0)
    436.0 (-9999 to 9999)
    318.0 (-9999 to 9999)
    330.0 (261.0 to 508.0)
    353.0 (326.0 to 9999)
    No statistical analyses for this end point

    Secondary: Part B: Secondary measures change in efficacy - OS at 12 months

    		 Close Top of page
    End point title
    		 Part B: Secondary measures change in efficacy - OS at 12 months
    End point description
    proportion of patients alive at 12 months: the percentage of patients surviving at 12 months after randomization to study drug
    End point type
    Secondary
    End point timeframe
    Assessed at every even-numbered cycles. Assessed at every even numbered cycle with RECIST until disease progression, up to 12 months
    End point values
    		 Part B1:AZD9150+MEDI4736:PDL1 pretreated Part B2:AZD5069+MEDI4736:PDL1 pretreated Part B3: AZD9150+MED4736:naiive 2L Part B4:AZD5069+MEDI4736:naiive patients Part B5: AZD9150 in naiive patients Part B6a: AZD5069 40mg BID Fed/Fasted Part B7: AZD9150+MEDI4736: naiive 1L Part B8: AZD9150 (every other week)+MEDI4736: naive 1L
    Number of subjects analysed
    24
    20
    53
    22
    14
    1
    55
    50
    Units: Percentage of participants
        number (confidence interval 80%)
    18.2 (9.1 to 29.7)
    42.5 (27.9 to 56.4)
    39.7 (30.9 to 48.4)
    46.4 (31.0 to 60.5)
    30.8 (15.7 to 47.2)
    100.0 (100.0 to 100.0)
    46.5 (37.6 to 54.9)
    46.3 (34.4 to 57.3)
    No statistical analyses for this end point

    Secondary: Part B: Evaluation of AZD9150 Pharmacodynamics: Change in STAT3 RNA level from baseline

    		 Close Top of page
    End point title
    		 Part B: Evaluation of AZD9150 Pharmacodynamics: Change in STAT3 RNA level from baseline
    End point description
    Percent STAT3 RNA change in expression level in peripheral blood in patients who had baseline (Screening or Day -7) sample for comparison. Data were only available for B1, B3, B5, B7 and B8.
    End point type
    Secondary
    End point timeframe
    At Cycle 2 Day 1 vs. Baseline
    End point values
    		 Part B1: AZD9150+MEDI4736:PDL1 pretreated (PD set) Part B3: AZD9150+MEDI4736:naive 2L (PD set) Part B5: AZD9150 in naive patients (PD set) Part B7: AZD9150+MEDI4736:naive 1L (PD set) Part B8: AZD9150 (every other week)+MEDI4736:naive 1L (PD set)
    Number of subjects analysed
    8
    29
    5
    30
    34
    Units: Percent
        median (full range (min-max))
    -2.9 (-30 to 40)
    -9.8 (-59 to 205)
    -6.7 (-33 to 73)
    -22.9 (-65 to 63)
    -27.1 (-72 to 26)
    No statistical analyses for this end point

    Secondary: Part B: Evaluation of PDL1 expression

    		 Close Top of page
    End point title
    		 Part B: Evaluation of PDL1 expression
    End point description
    Tumors with PDL1-positive tumor cells at the designated cutoff. Data were only available for B1, B2, B3, B4, B7 and B8.
    End point type
    Secondary
    End point timeframe
    in baseline tumor samples
    End point values
    		 Part B1:AZD9150+MEDI4736:PDL1 pretreated Part B2:AZD5069+MEDI4736:PDL1 pretreated Part B3:AZD9150+MEDI4736:naive 2L Part B4:AZD9150+MEDI4736:naive patients Part B7:AZD9150+MEDI4736:naive 1L Part B8:AZD9150(every other week)+MEDi4736:naive 1L
    Number of subjects analysed
    21
    18
    49
    21
    48
    36
    Units: Participants
        Patients with PDL1 expression >=1% in tumor cells
    15
    12
    27
    15
    27
    21
        Patients with PDL1 expression >=50% in tumor cells
    8
    4
    12
    5
    8
    7
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug until last study visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    A1C1: AZD9150 2mg/kg + MEDI4736 20mg/kg
    Reporting group description
    		 -

    Reporting group title
    A2C1: AZD5069 40mg BID + MEDI4736 20mg/kg
    Reporting group description
    		 -

    Reporting group title
    A1C2: AZD9150 3mg/kg + MEDI4736 20mg/kg
    Reporting group description
    		 -

    Reporting group title
    A2C2: AZD5069 80mg BID + MEDI4736 20mg/kg
    Reporting group description
    		 -

    Reporting group title
    A3C1: AZD5069 80mg BID + MEDI4736 20mg/kg
    Reporting group description
    		 -

    Reporting group title
    A4C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme
    Reporting group description
    		 -

    Reporting group title
    A6C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg
    Reporting group description
    		 -

    Reporting group title
    A4C3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme
    Reporting group description
    		 -

    Reporting group title
    A4C2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme
    Reporting group description
    		 -

    Reporting group title
    B1: AZD9150 3mg/kg + MEDI4736 20mg/kg Exp
    Reporting group description
    		 -

    Reporting group title
    B6a: AZD5069 40mg BID Fed/Fasted
    Reporting group description
    		 -

    Reporting group title
    B6: AZD5069 40mg BID
    Reporting group description
    		 -

    Reporting group title
    B2: AZD5069 40mg BID + MEDI4736 20mg/kg Exp
    Reporting group description
    		 -

    Reporting group title
    B3: AZD9150 3mg/kg + MEDI4736 20mg/kg Naive
    Reporting group description
    		 -

    Reporting group title
    B4: AZD5069 40mg BID + MEDI4736 20mg/kg Naive
    Reporting group description
    		 -

    Reporting group title
    B5: AZD9150 3mg/kg
    Reporting group description
    		 -

    Reporting group title
    B7: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg
    Reporting group description
    		 -

    Reporting group title
    B6b: AZD5069 40mg BID Fasted/Fed
    Reporting group description
    		 -

    Reporting group title
    B8: AZD9150 400mg q2w + MEDI4736 1.5g Q4W
    Reporting group description
    		 -

    Serious adverse events
    		 A1C1: AZD9150 2mg/kg + MEDI4736 20mg/kg A2C1: AZD5069 40mg BID + MEDI4736 20mg/kg A1C2: AZD9150 3mg/kg + MEDI4736 20mg/kg A2C2: AZD5069 80mg BID + MEDI4736 20mg/kg A3C1: AZD5069 80mg BID + MEDI4736 20mg/kg A4C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme A6C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg A4C3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme A4C2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme B1: AZD9150 3mg/kg + MEDI4736 20mg/kg Exp B6a: AZD5069 40mg BID Fed/Fasted B6: AZD5069 40mg BID B2: AZD5069 40mg BID + MEDI4736 20mg/kg Exp B3: AZD9150 3mg/kg + MEDI4736 20mg/kg Naive B4: AZD5069 40mg BID + MEDI4736 20mg/kg Naive B5: AZD9150 3mg/kg B7: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg B6b: AZD5069 40mg BID Fasted/Fed B8: AZD9150 400mg q2w + MEDI4736 1.5g Q4W
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 4 (0.00%)
    3 / 9 (33.33%)
    1 / 7 (14.29%)
    5 / 11 (45.45%)
    5 / 15 (33.33%)
    5 / 9 (55.56%)
    3 / 14 (21.43%)
    2 / 6 (33.33%)
    2 / 7 (28.57%)
    10 / 24 (41.67%)
    1 / 1 (100.00%)
    6 / 10 (60.00%)
    7 / 20 (35.00%)
    30 / 53 (56.60%)
    9 / 22 (40.91%)
    9 / 14 (64.29%)
    28 / 55 (50.91%)
    0 / 1 (0.00%)
    21 / 50 (42.00%)
         number of deaths (all causes)
    2
    5
    3
    6
    9
    8
    7
    1
    6
    21
    1
    9
    18
    41
    16
    11
    35
    1
    22
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    1
    1
    6
    0
    2
    5
    0
    7
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Head and neck cancer
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Tumour flare
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tumour invasion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Tumour haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    2 / 53 (3.77%)
    0 / 22 (0.00%)
    2 / 14 (14.29%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         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
    1 / 2
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Vascular disorders
    Arterial haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Embolism
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Hypotension
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    2 / 53 (3.77%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 occlusion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Superior vena cava occlusion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    4 / 53 (7.55%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 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
    Chest pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Euthanasia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 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
    Complication associated with device
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 1
    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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Face oedema
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Localised oedema
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Medical device site haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mucosal dryness
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Obstruction
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    2 / 53 (3.77%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    1 / 2
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 respiratory distress syndrome
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asphyxia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Aspiration
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    4 / 53 (7.55%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    0 / 50 (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
    1 / 4
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 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
    Haemoptysis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    1 / 1 (100.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    2 / 53 (3.77%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 oedema
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    3 / 55 (5.45%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 5
    0 / 0
    0 / 2
    1 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    3 / 53 (5.66%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    3 / 55 (5.45%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         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 / 4
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 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 / 1
    0 / 0
    0 / 1
    Pneumonitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    1 / 20 (5.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 alveolar haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    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
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device dislocation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device extrusion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Amylase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    2 / 53 (3.77%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    2 / 2
    0 / 0
    0 / 0
    2 / 2
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 creatine phosphokinase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oxygen saturation decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Hip fracture
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stoma site haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tracheal obstruction
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    1 / 15 (6.67%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiotoxicity
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocarditis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (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
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    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
    Palpitations
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (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
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 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
    Pulmonary valve incompetence
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Tachycardia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    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
    Cerebral venous thrombosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial nerve disorder
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxic-ischaemic encephalopathy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Ischaemic stroke
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    2 / 53 (3.77%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood loss anaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 disorders
    Abdominal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    2 / 15 (13.33%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 enteropathy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    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 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    1 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    1 / 2
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis haemorrhagic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths 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
    Haematemesis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mouth haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal perforation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obstruction gastric
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Cholestasis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug-induced liver injury
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         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
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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-mediated hepatitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         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
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 and subcutaneous tissue disorders
    Skin haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Calculus bladder
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 failure
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Hypercalcaemia of malignancy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperthyroidism
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypothyroidism
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 in jaw
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bacteraemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis bacterial
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Campylobacter gastroenteritis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    2 / 9 (22.22%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Endocarditis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Infestation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         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 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (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
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphangitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mucosal infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    1 / 15 (6.67%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    3 / 24 (12.50%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    2 / 20 (10.00%)
    2 / 53 (3.77%)
    2 / 22 (9.09%)
    1 / 14 (7.14%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 3
    0 / 0
    0 / 1
    0 / 2
    1 / 2
    0 / 2
    0 / 1
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Pleural infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    1 / 22 (4.55%)
    2 / 14 (14.29%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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 / 2
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stoma site infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Superinfection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 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
    Hyperglycaemic hyperosmolar nonketotic syndrome
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences causally related to treatment / all
    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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         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
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (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 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 A1C1: AZD9150 2mg/kg + MEDI4736 20mg/kg A2C1: AZD5069 40mg BID + MEDI4736 20mg/kg A1C2: AZD9150 3mg/kg + MEDI4736 20mg/kg A2C2: AZD5069 80mg BID + MEDI4736 20mg/kg A3C1: AZD5069 80mg BID + MEDI4736 20mg/kg A4C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg + Treme A6C1: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg A4C3: AZD9150 3mg/kg q2w + MEDI4736 20mg/kg + Treme A4C2: AZD9150 2mg/kg q1w + MEDI4736 20mg/kg + Treme B1: AZD9150 3mg/kg + MEDI4736 20mg/kg Exp B6a: AZD5069 40mg BID Fed/Fasted B6: AZD5069 40mg BID B2: AZD5069 40mg BID + MEDI4736 20mg/kg Exp B3: AZD9150 3mg/kg + MEDI4736 20mg/kg Naive B4: AZD5069 40mg BID + MEDI4736 20mg/kg Naive B5: AZD9150 3mg/kg B7: AZD9150 3mg/kg q1w + MEDI4736 20mg/kg B6b: AZD5069 40mg BID Fasted/Fed B8: AZD9150 400mg q2w + MEDI4736 1.5g Q4W
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 4 (100.00%)
    9 / 9 (100.00%)
    7 / 7 (100.00%)
    11 / 11 (100.00%)
    15 / 15 (100.00%)
    9 / 9 (100.00%)
    14 / 14 (100.00%)
    5 / 6 (83.33%)
    7 / 7 (100.00%)
    22 / 24 (91.67%)
    1 / 1 (100.00%)
    10 / 10 (100.00%)
    19 / 20 (95.00%)
    51 / 53 (96.23%)
    20 / 22 (90.91%)
    14 / 14 (100.00%)
    55 / 55 (100.00%)
    1 / 1 (100.00%)
    48 / 50 (96.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Infected neoplasm
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    0
    0
    Tumour pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    3 / 24 (12.50%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    2 / 20 (10.00%)
    3 / 53 (5.66%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    4 / 55 (7.27%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    3
    0
    1
    3
    3
    1
    0
    4
    0
    2
    Tumour haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 24 (8.33%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    2 / 20 (10.00%)
    0 / 53 (0.00%)
    2 / 22 (9.09%)
    3 / 14 (21.43%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    2
    0
    2
    5
    1
    0
    0
    Tumour ulceration
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    2 / 22 (9.09%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Vascular disorders
    Embolism
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    1
    0
    1
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    Hypertension
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    1 / 1 (100.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    8 / 53 (15.09%)
    4 / 22 (18.18%)
    0 / 14 (0.00%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    2
    0
    2
    10
    7
    0
    3
    0
    5
    Hypotension
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 24 (8.33%)
    1 / 1 (100.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    4 / 53 (7.55%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    3 / 55 (5.45%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    4
    1
    0
    1
    5
    0
    0
    3
    0
    2
    Lymphoedema
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    2 / 14 (14.29%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    3
    0
    0
    0
    0
    1
    0
    1
    1
    0
    0
    0
    0
    Venous thrombosis limb
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    General disorders and administration site conditions
    Catheter site pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    2 / 53 (3.77%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    2
    0
    0
    0
    0
    0
    Asthenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    5 / 24 (20.83%)
    0 / 1 (0.00%)
    2 / 10 (20.00%)
    2 / 20 (10.00%)
    11 / 53 (20.75%)
    5 / 22 (22.73%)
    4 / 14 (28.57%)
    9 / 55 (16.36%)
    0 / 1 (0.00%)
    5 / 50 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    6
    0
    2
    5
    18
    7
    4
    24
    0
    7
    Catheter site erythema
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Chest discomfort
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    Chest pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    2 / 15 (13.33%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    1 / 1 (100.00%)
    1 / 10 (10.00%)
    1 / 20 (5.00%)
    4 / 53 (7.55%)
    2 / 22 (9.09%)
    1 / 14 (7.14%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    0
    0
    5
    1
    0
    0
    0
    1
    1
    1
    1
    6
    2
    1
    1
    0
    1
    Chills
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    2 / 9 (22.22%)
    2 / 14 (14.29%)
    1 / 6 (16.67%)
    2 / 7 (28.57%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    0
    0
    0
    1
    2
    2
    1
    2
    1
    0
    0
    0
    1
    0
    0
    2
    0
    2
    Complication associated with device
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Early satiety
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Face oedema
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    4 / 53 (7.55%)
    2 / 22 (9.09%)
    0 / 14 (0.00%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    4
    2
    0
    2
    0
    1
    Facial pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    1
    2
    0
    4
    Fatigue
         subjects affected / exposed
    0 / 4 (0.00%)
    5 / 9 (55.56%)
    4 / 7 (57.14%)
    3 / 11 (27.27%)
    4 / 15 (26.67%)
    4 / 9 (44.44%)
    7 / 14 (50.00%)
    2 / 6 (33.33%)
    4 / 7 (57.14%)
    7 / 24 (29.17%)
    0 / 1 (0.00%)
    4 / 10 (40.00%)
    7 / 20 (35.00%)
    20 / 53 (37.74%)
    6 / 22 (27.27%)
    2 / 14 (14.29%)
    24 / 55 (43.64%)
    1 / 1 (100.00%)
    17 / 50 (34.00%)
         occurrences all number
    0
    5
    5
    6
    4
    5
    7
    4
    6
    9
    0
    4
    7
    25
    7
    2
    29
    1
    21
    Gait disturbance
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    Inflammation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    1 / 1 (100.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Impaired healing
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    General physical health deterioration
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    2 / 10 (20.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    1
    0
    0
    Influenza like illness
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Oedema
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    2 / 24 (8.33%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    3 / 53 (5.66%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    1
    3
    0
    0
    2
    0
    0
    Mucosal inflammation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    1 / 11 (9.09%)
    2 / 15 (13.33%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    2 / 53 (3.77%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    0
    1
    2
    2
    0
    0
    0
    0
    0
    0
    1
    0
    2
    0
    1
    2
    0
    2
    Malaise
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    2 / 15 (13.33%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    4
    1
    0
    1
    0
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    2 / 7 (28.57%)
    2 / 11 (18.18%)
    1 / 15 (6.67%)
    2 / 9 (22.22%)
    3 / 14 (21.43%)
    2 / 6 (33.33%)
    1 / 7 (14.29%)
    2 / 24 (8.33%)
    0 / 1 (0.00%)
    2 / 10 (20.00%)
    1 / 20 (5.00%)
    4 / 53 (7.55%)
    2 / 22 (9.09%)
    0 / 14 (0.00%)
    7 / 55 (12.73%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    3
    2
    2
    1
    2
    3
    3
    1
    2
    0
    3
    1
    6
    2
    0
    10
    0
    0
    Pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    2 / 11 (18.18%)
    0 / 15 (0.00%)
    3 / 9 (33.33%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    3 / 24 (12.50%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    4 / 53 (7.55%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    3
    1
    0
    1
    3
    0
    0
    0
    5
    1
    0
    1
    0
    0
    Performance status decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Peripheral swelling
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    2 / 14 (14.29%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    3
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    2
    Pyrexia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    3 / 11 (27.27%)
    2 / 15 (13.33%)
    2 / 9 (22.22%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    4 / 24 (16.67%)
    1 / 1 (100.00%)
    2 / 10 (20.00%)
    6 / 20 (30.00%)
    7 / 53 (13.21%)
    2 / 22 (9.09%)
    3 / 14 (21.43%)
    8 / 55 (14.55%)
    1 / 1 (100.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    0
    0
    3
    2
    2
    1
    0
    0
    7
    1
    2
    10
    10
    3
    4
    10
    2
    3
    Secretion discharge
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    2
    2
    0
    1
    Swelling
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    2 / 22 (9.09%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Seasonal allergy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    2 / 11 (18.18%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    Pruritus genital
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Pelvic pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    Breast induration
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Scrotal haematocoele
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Scrotal erythema
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Scrotal swelling
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Vaginal disorder
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Vulvovaginal pruritus
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Bronchial haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    1 / 1 (100.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    2 / 15 (13.33%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Cough
         subjects affected / exposed
    2 / 4 (50.00%)
    2 / 9 (22.22%)
    1 / 7 (14.29%)
    3 / 11 (27.27%)
    3 / 15 (20.00%)
    1 / 9 (11.11%)
    1 / 14 (7.14%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    6 / 24 (25.00%)
    1 / 1 (100.00%)
    1 / 10 (10.00%)
    5 / 20 (25.00%)
    12 / 53 (22.64%)
    6 / 22 (27.27%)
    2 / 14 (14.29%)
    16 / 55 (29.09%)
    1 / 1 (100.00%)
    1 / 50 (2.00%)
         occurrences all number
    2
    2
    3
    4
    3
    1
    1
    1
    1
    6
    3
    1
    6
    15
    7
    2
    17
    1
    1
    Dry throat
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    1 / 53 (1.89%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    1
    0
    0
    0
    0
    Dysphonia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    0 / 53 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    1
    1
    1
    0
    2
    Dyspnoea exertional
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    1 / 7 (14.29%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    2 / 14 (14.29%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    1 / 1 (100.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    7 / 53 (13.21%)
    1 / 22 (4.55%)
    3 / 14 (21.43%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    1
    1
    0
    0
    2
    0
    0
    1
    1
    0
    0
    7
    1
    3
    1
    0
    2
    Dyspnoea
         subjects affected / exposed
    1 / 4 (25.00%)
    3 / 9 (33.33%)
    2 / 7 (28.57%)
    4 / 11 (36.36%)
    4 / 15 (26.67%)
    2 / 9 (22.22%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    3 / 7 (42.86%)
    5 / 24 (20.83%)
    0 / 1 (0.00%)
    4 / 10 (40.00%)
    5 / 20 (25.00%)
    16 / 53 (30.19%)
    4 / 22 (18.18%)
    5 / 14 (35.71%)
    8 / 55 (14.55%)
    1 / 1 (100.00%)
    8 / 50 (16.00%)
         occurrences all number
    1
    3
    2
    4
    4
    2
    1
    0
    3
    7
    0
    6
    5
    18
    5
    7
    8
    1
    9
    Epistaxis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    2 / 53 (3.77%)
    2 / 22 (9.09%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    0
    0
    1
    0
    2
    0
    0
    0
    1
    0
    0
    1
    5
    2
    0
    2
    0
    3
    Haemoptysis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    4 / 24 (16.67%)
    1 / 1 (100.00%)
    0 / 10 (0.00%)
    2 / 20 (10.00%)
    5 / 53 (9.43%)
    0 / 22 (0.00%)
    2 / 14 (14.29%)
    3 / 55 (5.45%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    1
    1
    4
    3
    0
    2
    5
    0
    2
    3
    0
    2
    Laryngeal oedema
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    1 / 22 (4.55%)
    2 / 14 (14.29%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    2
    0
    0
    0
    Hypoxia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    1
    0
    1
    1
    0
    0
    Lung disorder
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Lung infiltration
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Nasal congestion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    2
    0
    0
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    4 / 53 (7.55%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    4 / 55 (7.27%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    1
    1
    0
    1
    0
    1
    0
    1
    0
    0
    1
    6
    0
    0
    4
    0
    2
    Paranasal sinus discomfort
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Pleural effusion
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 9 (22.22%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    2 / 14 (14.29%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    2
    0
    1
    0
    2
    0
    0
    1
    0
    0
    1
    0
    1
    0
    2
    1
    0
    5
    Pleuritic pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 24 (8.33%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Pneumothorax
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    Productive cough
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    2 / 24 (8.33%)
    0 / 1 (0.00%)
    2 / 10 (20.00%)
    1 / 20 (5.00%)
    11 / 53 (20.75%)
    2 / 22 (9.09%)
    1 / 14 (7.14%)
    7 / 55 (12.73%)
    0 / 1 (0.00%)
    5 / 50 (10.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    1
    0
    3
    0
    2
    1
    13
    2
    1
    10
    0
    5
    Pulmonary embolism
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    1
    Pneumonitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    5 / 55 (9.09%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    6
    0
    0
    Respiratory tract congestion
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Sputum increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    Sinus congestion
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    2 / 15 (13.33%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    4 / 53 (7.55%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    2
    0
    0
    0
    0
    1
    0
    0
    2
    4
    0
    1
    2
    0
    0
    Throat tightness
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Upper-airway cough syndrome
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    Wheezing
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    1
    1
    2
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 9 (22.22%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    2 / 7 (28.57%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    2 / 53 (3.77%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    2
    1
    0
    0
    1
    0
    0
    2
    0
    0
    0
    1
    3
    0
    1
    1
    0
    2
    Adjustment disorder with depressed mood
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Confusional state
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Depression
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    2 / 15 (13.33%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    3 / 53 (5.66%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    5 / 50 (10.00%)
         occurrences all number
    0
    1
    1
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    3
    1
    0
    2
    0
    5
    Insomnia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    2 / 7 (28.57%)
    2 / 11 (18.18%)
    1 / 15 (6.67%)
    3 / 9 (33.33%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    1 / 1 (100.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    3 / 53 (5.66%)
    1 / 22 (4.55%)
    3 / 14 (21.43%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    7 / 50 (14.00%)
         occurrences all number
    0
    0
    2
    2
    1
    3
    0
    1
    0
    1
    1
    0
    0
    3
    1
    3
    2
    0
    7
    Restlessness
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Suicidal ideation
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 9 (0.00%)
    4 / 7 (57.14%)
    1 / 11 (9.09%)
    2 / 15 (13.33%)
    4 / 9 (44.44%)
    9 / 14 (64.29%)
    3 / 6 (50.00%)
    1 / 7 (14.29%)
    8 / 24 (33.33%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    13 / 53 (24.53%)
    1 / 22 (4.55%)
    3 / 14 (21.43%)
    24 / 55 (43.64%)
    0 / 1 (0.00%)
    20 / 50 (40.00%)
         occurrences all number
    2
    0
    6
    1
    2
    8
    11
    4
    1
    12
    0
    0
    2
    24
    1
    4
    34
    0
    32
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 4 (50.00%)
    1 / 9 (11.11%)
    3 / 7 (42.86%)
    1 / 11 (9.09%)
    2 / 15 (13.33%)
    5 / 9 (55.56%)
    9 / 14 (64.29%)
    3 / 6 (50.00%)
    2 / 7 (28.57%)
    7 / 24 (29.17%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    2 / 20 (10.00%)
    13 / 53 (24.53%)
    1 / 22 (4.55%)
    3 / 14 (21.43%)
    21 / 55 (38.18%)
    0 / 1 (0.00%)
    21 / 50 (42.00%)
         occurrences all number
    2
    1
    4
    1
    2
    8
    12
    4
    2
    11
    0
    1
    3
    25
    1
    3
    29
    0
    37
    Blood cholesterol decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    2 / 15 (13.33%)
    3 / 9 (33.33%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    0
    0
    0
    2
    3
    1
    0
    1
    0
    0
    1
    0
    4
    1
    0
    3
    0
    3
    Bilirubin conjugated increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    1 / 15 (6.67%)
    1 / 9 (11.11%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    1 / 20 (5.00%)
    3 / 53 (5.66%)
    1 / 22 (4.55%)
    4 / 14 (28.57%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    4 / 50 (8.00%)
         occurrences all number
    0
    0
    0
    2
    1
    1
    1
    0
    0
    0
    0
    1
    2
    5
    2
    4
    2
    0
    5
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    2 / 53 (3.77%)
    2 / 22 (9.09%)
    0 / 14 (0.00%)
    7 / 55 (12.73%)
    0 / 1 (0.00%)
    5 / 50 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    3
    2
    0
    7
    0
    8
    Blood creatine increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Blood fibrinogen decreased
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood creatinine increased
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 9 (0.00%)
    2 / 7 (28.57%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    1 / 20 (5.00%)
    3 / 53 (5.66%)
    2 / 22 (9.09%)
    1 / 14 (7.14%)
    3 / 55 (5.45%)
    0 / 1 (0.00%)
    4 / 50 (8.00%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    0
    0
    0
    1
    0
    1
    2
    3
    2
    1
    7
    0
    6
    Blood cholesterol increased
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    2 / 53 (3.77%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    2
    0
    0
    3
    0
    1
    Blood fibrinogen increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    2
    1
    0
    0
    Blood phosphorus decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood glucose increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Blood potassium decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood phosphorus increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood uric acid increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    0
    0
    Blood triglycerides increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Blood pressure increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    3
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    2 / 10 (20.00%)
    2 / 20 (10.00%)
    6 / 53 (11.32%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
    11 / 55 (20.00%)
    0 / 1 (0.00%)
    6 / 50 (12.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    1
    0
    0
    0
    0
    3
    3
    7
    1
    1
    12
    0
    7
    Computerised tomogram thorax abnormal
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    International normalised ratio increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    C-reactive protein increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    2 / 55 (3.64%)
    1 / 1 (100.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    3
    1
    0
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    3
    0
    1
    Liver function test abnormal
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    1
    0
    0
    Neutrophil count decreased
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 9 (11.11%)
    2 / 7 (28.57%)
    2 / 11 (18.18%)
    4 / 15 (26.67%)
    0 / 9 (0.00%)
    4 / 14 (28.57%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    4 / 53 (7.55%)
    3 / 22 (13.64%)
    0 / 14 (0.00%)
    7 / 55 (12.73%)
    0 / 1 (0.00%)
    6 / 50 (12.00%)
         occurrences all number
    4
    1
    6
    27
    7
    0
    5
    1
    0
    0
    0
    0
    0
    10
    4
    0
    28
    0
    7
    Liver function test increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    2
    0
    0
    Sinus rhythm
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Neutrophil count increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    Thyroxine free decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Platelet count decreased
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 9 (0.00%)
    3 / 7 (42.86%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    2 / 9 (22.22%)
    6 / 14 (42.86%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    3 / 24 (12.50%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    8 / 53 (15.09%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    10 / 55 (18.18%)
    0 / 1 (0.00%)
    8 / 50 (16.00%)
         occurrences all number
    3
    0
    7
    1
    0
    3
    8
    1
    0
    7
    0
    1
    0
    29
    0
    0
    30
    0
    10
    Tri-iodothyronine decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Urine output decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Transaminases increased
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    3 / 24 (12.50%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    3 / 53 (5.66%)
    1 / 22 (4.55%)
    2 / 14 (14.29%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    1
    0
    0
    3
    0
    0
    0
    5
    1
    4
    0
    0
    3
    White blood cell count decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    3 / 14 (21.43%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    8 / 55 (14.55%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    1
    0
    0
    2
    0
    3
    1
    2
    0
    0
    0
    0
    4
    0
    0
    15
    0
    3
    Weight increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    7
    0
    0
    0
    0
    0
    Weight decreased
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 9 (11.11%)
    2 / 7 (28.57%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    2 / 9 (22.22%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    3 / 24 (12.50%)
    1 / 1 (100.00%)
    1 / 10 (10.00%)
    2 / 20 (10.00%)
    11 / 53 (20.75%)
    3 / 22 (13.64%)
    2 / 14 (14.29%)
    6 / 55 (10.91%)
    0 / 1 (0.00%)
    5 / 50 (10.00%)
         occurrences all number
    1
    2
    2
    0
    0
    3
    0
    0
    1
    3
    1
    1
    2
    12
    3
    2
    6
    0
    5
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    1 / 9 (11.11%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    1
    0
    1
    0
    0
    0
    1
    2
    0
    0
    0
    0
    0
    Protein C increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    1 / 1 (100.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Animal scratch
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Bone fissure
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Craniocerebral injury
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Contusion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    3 / 9 (33.33%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    1
    0
    3
    1
    0
    0
    1
    0
    0
    0
    1
    0
    0
    1
    0
    1
    Fall
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    2 / 9 (22.22%)
    1 / 14 (7.14%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    3 / 55 (5.45%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    3
    0
    0
    0
    2
    2
    2
    2
    0
    0
    0
    0
    1
    0
    0
    0
    4
    0
    0
    Gastrointestinal stoma complication
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Head injury
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Gastrostomy tube site complication
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Joint injury
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Post procedural complication
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 24 (8.33%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Limb injury
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 24 (8.33%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    1
    0
    0
    0
    0
    1
    Procedural pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    3 / 53 (5.66%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    4
    0
    1
    1
    0
    0
    Post procedural oedema
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Radiation injury
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Rib fracture
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Skin abrasion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    2 / 9 (22.22%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    2
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Stoma site haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Skin laceration
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Tracheal obstruction
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Stoma site pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 24 (8.33%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Tracheostomy malfunction
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    1
    0
    0
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    2 / 53 (3.77%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    1
    1
    0
    0
    Bundle branch block right
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Bradycardia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Cardiac arrest
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Atrioventricular block first degree
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Palpitations
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Cardiogenic shock
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Tachyarrhythmia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    1 / 1 (100.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Pericardial effusion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    Nervous system disorders
    Ataxia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Balance disorder
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Amnesia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Brain oedema
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Dizziness
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    3 / 9 (33.33%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    2 / 20 (10.00%)
    5 / 53 (9.43%)
    3 / 22 (13.64%)
    0 / 14 (0.00%)
    7 / 55 (12.73%)
    0 / 1 (0.00%)
    8 / 50 (16.00%)
         occurrences all number
    2
    2
    0
    0
    0
    4
    0
    1
    0
    1
    0
    1
    2
    6
    3
    0
    9
    0
    10
    Disturbance in attention
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Dizziness postural
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dysgeusia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    1
    0
    0
    Dysaesthesia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Facial paralysis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Hypersomnia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Headache
         subjects affected / exposed
    2 / 4 (50.00%)
    1 / 9 (11.11%)
    1 / 7 (14.29%)
    2 / 11 (18.18%)
    1 / 15 (6.67%)
    2 / 9 (22.22%)
    1 / 14 (7.14%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    3 / 24 (12.50%)
    1 / 1 (100.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    10 / 53 (18.87%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    10 / 55 (18.18%)
    0 / 1 (0.00%)
    10 / 50 (20.00%)
         occurrences all number
    2
    2
    1
    2
    1
    2
    1
    1
    0
    4
    2
    1
    0
    20
    1
    0
    12
    0
    11
    Hypoaesthesia
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 9 (22.22%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    1
    Memory impairment
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Paraesthesia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    2 / 53 (3.77%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    2
    0
    0
    1
    0
    0
    Neuropathy peripheral
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    3 / 55 (5.45%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    3
    0
    0
    Neuralgia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    1 / 20 (5.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    1
    0
    0
    Presyncope
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Restless legs syndrome
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Somnolence
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    1 / 1 (100.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    2 / 53 (3.77%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    3
    1
    0
    1
    0
    0
    Sinus headache
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Stupor
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Syncope
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    3 / 55 (5.45%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    4
    0
    1
    Tremor
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    1 / 1 (100.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    2 / 14 (14.29%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    2
    1
    0
    0
    Blood and lymphatic system disorders
    Leukocytosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    1 / 1 (100.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    3 / 15 (20.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Disseminated intravascular coagulation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Anaemia
         subjects affected / exposed
    2 / 4 (50.00%)
    1 / 9 (11.11%)
    3 / 7 (42.86%)
    2 / 11 (18.18%)
    3 / 15 (20.00%)
    4 / 9 (44.44%)
    4 / 14 (28.57%)
    2 / 6 (33.33%)
    0 / 7 (0.00%)
    5 / 24 (20.83%)
    0 / 1 (0.00%)
    7 / 10 (70.00%)
    8 / 20 (40.00%)
    20 / 53 (37.74%)
    6 / 22 (27.27%)
    3 / 14 (21.43%)
    20 / 55 (36.36%)
    0 / 1 (0.00%)
    23 / 50 (46.00%)
         occurrences all number
    3
    1
    8
    2
    3
    5
    6
    6
    0
    7
    0
    7
    8
    39
    11
    6
    46
    0
    30
    Leukopenia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    2 / 53 (3.77%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    2
    0
    3
    0
    0
    Lymphadenopathy
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Lymphatic disorder
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neutropenia
         subjects affected / exposed
    2 / 4 (50.00%)
    3 / 9 (33.33%)
    0 / 7 (0.00%)
    2 / 11 (18.18%)
    3 / 15 (20.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    3 / 10 (30.00%)
    4 / 20 (20.00%)
    2 / 53 (3.77%)
    3 / 22 (13.64%)
    0 / 14 (0.00%)
    5 / 55 (9.09%)
    0 / 1 (0.00%)
    5 / 50 (10.00%)
         occurrences all number
    3
    5
    0
    4
    6
    0
    1
    0
    1
    1
    0
    7
    8
    10
    23
    0
    17
    0
    7
    Thrombocytopenia
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    2 / 9 (22.22%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    2 / 7 (28.57%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    8 / 53 (15.09%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    10 / 55 (18.18%)
    0 / 1 (0.00%)
    10 / 50 (20.00%)
         occurrences all number
    3
    0
    1
    0
    0
    4
    0
    0
    2
    0
    0
    0
    0
    13
    0
    1
    12
    0
    11
    Ear and labyrinth disorders
    Ear discomfort
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Hypoacusis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    1
    Ear pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    3 / 24 (12.50%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    4 / 55 (7.27%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    5
    0
    0
    0
    0
    0
    0
    4
    0
    1
    Tinnitus
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Vertigo
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Eye disorders
    Diplopia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    1
    1
    0
    0
    0
    0
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dry eye
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    1
    Eye pruritus
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Eye pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Eye irritation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Eyelid ptosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Ocular hyperaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Ophthalmoplegia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Periorbital oedema
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Swelling of eyelid
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Vision blurred
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    1
    0
    0
    1
    0
    1
    Visual impairment
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    2 / 53 (3.77%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    2
    1
    0
    0
    1
    0
    0
    0
    3
    1
    0
    1
    0
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    1 / 9 (11.11%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    0
    0
    1
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    Abdominal distension
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    1 / 11 (9.09%)
    1 / 15 (6.67%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    3 / 22 (13.64%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    1
    1
    1
    0
    0
    0
    2
    0
    0
    0
    1
    3
    1
    0
    0
    0
    Abdominal tenderness
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    3 / 55 (5.45%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    0
    0
    2
    0
    0
    0
    2
    0
    0
    4
    0
    0
    Abdominal pain lower
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    2 / 11 (18.18%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Abdominal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    1 / 15 (6.67%)
    2 / 9 (22.22%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    1 / 20 (5.00%)
    4 / 53 (7.55%)
    1 / 22 (4.55%)
    2 / 14 (14.29%)
    4 / 55 (7.27%)
    0 / 1 (0.00%)
    7 / 50 (14.00%)
         occurrences all number
    0
    0
    0
    1
    2
    3
    1
    0
    1
    0
    0
    1
    1
    4
    1
    2
    4
    0
    7
    Abnormal faeces
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Anal incontinence
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Angular cheilitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Aphthous ulcer
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    2
    0
    0
    Ascites
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    1
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Breath odour
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    0
    0
    Diarrhoea
         subjects affected / exposed
    1 / 4 (25.00%)
    2 / 9 (22.22%)
    2 / 7 (28.57%)
    0 / 11 (0.00%)
    4 / 15 (26.67%)
    3 / 9 (33.33%)
    5 / 14 (35.71%)
    3 / 6 (50.00%)
    1 / 7 (14.29%)
    6 / 24 (25.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    2 / 20 (10.00%)
    11 / 53 (20.75%)
    5 / 22 (22.73%)
    1 / 14 (7.14%)
    9 / 55 (16.36%)
    0 / 1 (0.00%)
    12 / 50 (24.00%)
         occurrences all number
    3
    2
    2
    0
    12
    4
    5
    5
    1
    9
    0
    1
    3
    13
    11
    1
    12
    0
    18
    Defaecation urgency
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Constipation
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    2 / 7 (28.57%)
    1 / 11 (9.09%)
    1 / 15 (6.67%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    2 / 7 (28.57%)
    5 / 24 (20.83%)
    1 / 1 (100.00%)
    2 / 10 (20.00%)
    4 / 20 (20.00%)
    14 / 53 (26.42%)
    3 / 22 (13.64%)
    2 / 14 (14.29%)
    11 / 55 (20.00%)
    0 / 1 (0.00%)
    11 / 50 (22.00%)
         occurrences all number
    0
    1
    2
    2
    1
    1
    0
    0
    2
    5
    1
    2
    5
    17
    4
    2
    15
    0
    11
    Colitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Dry mouth
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    2 / 14 (14.29%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    1 / 20 (5.00%)
    4 / 53 (7.55%)
    0 / 22 (0.00%)
    2 / 14 (14.29%)
    3 / 55 (5.45%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    1
    0
    1
    0
    1
    1
    4
    0
    2
    3
    0
    2
    Dysphagia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    1 / 11 (9.09%)
    1 / 15 (6.67%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 24 (8.33%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    6 / 53 (11.32%)
    4 / 22 (18.18%)
    2 / 14 (14.29%)
    6 / 55 (10.91%)
    0 / 1 (0.00%)
    8 / 50 (16.00%)
         occurrences all number
    0
    0
    2
    1
    1
    2
    0
    0
    0
    2
    0
    0
    0
    7
    5
    2
    6
    0
    8
    Dyspepsia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    2 / 24 (8.33%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    3 / 53 (5.66%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    4
    0
    0
    2
    0
    1
    Enterocolitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Eructation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Flatulence
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    2 / 53 (3.77%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    1
    Faeces discoloured
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Frequent bowel movements
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Gastrointestinal polyp
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Functional gastrointestinal disorder
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    2 / 15 (13.33%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    3 / 55 (5.45%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    1
    2
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    3
    0
    0
    Gingival bleeding
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Glossitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Gingival pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Haematemesis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Haematochezia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    2 / 9 (22.22%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    3
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    Ileus
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nausea
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 9 (22.22%)
    2 / 7 (28.57%)
    3 / 11 (27.27%)
    4 / 15 (26.67%)
    4 / 9 (44.44%)
    0 / 14 (0.00%)
    3 / 6 (50.00%)
    1 / 7 (14.29%)
    4 / 24 (16.67%)
    1 / 1 (100.00%)
    3 / 10 (30.00%)
    2 / 20 (10.00%)
    9 / 53 (16.98%)
    5 / 22 (22.73%)
    1 / 14 (7.14%)
    11 / 55 (20.00%)
    0 / 1 (0.00%)
    8 / 50 (16.00%)
         occurrences all number
    0
    2
    4
    3
    7
    4
    0
    5
    1
    5
    1
    4
    2
    9
    5
    1
    12
    0
    13
    Melaena
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Large intestinal obstruction
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Oesophageal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Odynophagia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    3 / 53 (5.66%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
    3 / 55 (5.45%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    3
    1
    2
    4
    0
    0
    Noninfective gingivitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Oesophagitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Oral disorder
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Oral pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    2 / 53 (3.77%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    3 / 55 (5.45%)
    0 / 1 (0.00%)
    5 / 50 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    1
    3
    0
    6
    Palatal disorder
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    1
    Stomatitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    2 / 11 (18.18%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    4 / 53 (7.55%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    1 / 1 (100.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    1
    4
    0
    0
    1
    1
    1
    Toothache
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    2 / 15 (13.33%)
    1 / 9 (11.11%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    1
    2
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Vomiting
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 9 (11.11%)
    1 / 7 (14.29%)
    2 / 11 (18.18%)
    5 / 15 (33.33%)
    3 / 9 (33.33%)
    0 / 14 (0.00%)
    2 / 6 (33.33%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    2 / 10 (20.00%)
    3 / 20 (15.00%)
    9 / 53 (16.98%)
    3 / 22 (13.64%)
    3 / 14 (21.43%)
    7 / 55 (12.73%)
    0 / 1 (0.00%)
    6 / 50 (12.00%)
         occurrences all number
    1
    1
    1
    2
    7
    4
    0
    2
    0
    1
    0
    2
    3
    10
    4
    4
    7
    0
    8
    Hepatobiliary disorders
    Hepatotoxicity
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    2 / 14 (14.29%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    5
    0
    0
    0
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Actinic keratosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dermal cyst
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Cold sweat
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Decubitus ulcer
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    1
    1
    0
    0
    Dermatitis
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    1 / 53 (1.89%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    1
    1
    0
    1
    0
    0
    Ecchymosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Erythema
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 24 (8.33%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    2 / 20 (10.00%)
    0 / 53 (0.00%)
    4 / 22 (18.18%)
    0 / 14 (0.00%)
    3 / 55 (5.45%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    1
    2
    0
    6
    0
    3
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Lividity
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Dermatitis contact
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dry skin
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    2 / 53 (3.77%)
    2 / 22 (9.09%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    3
    2
    0
    1
    0
    1
    Petechiae
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nail bed bleeding
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Night sweats
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    Onychoclasis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pruritus
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 9 (11.11%)
    1 / 7 (14.29%)
    1 / 11 (9.09%)
    1 / 15 (6.67%)
    4 / 9 (44.44%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    3 / 24 (12.50%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    8 / 53 (15.09%)
    5 / 22 (22.73%)
    1 / 14 (7.14%)
    6 / 55 (10.91%)
    0 / 1 (0.00%)
    7 / 50 (14.00%)
         occurrences all number
    1
    3
    2
    1
    1
    5
    0
    1
    1
    4
    0
    1
    0
    10
    7
    1
    6
    0
    10
    Psoriasis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    2
    1
    0
    0
    0
    0
    Rash
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    1 / 15 (6.67%)
    5 / 9 (55.56%)
    1 / 14 (7.14%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    2 / 24 (8.33%)
    1 / 1 (100.00%)
    1 / 10 (10.00%)
    3 / 20 (15.00%)
    7 / 53 (13.21%)
    4 / 22 (18.18%)
    0 / 14 (0.00%)
    7 / 55 (12.73%)
    0 / 1 (0.00%)
    6 / 50 (12.00%)
         occurrences all number
    1
    1
    0
    1
    1
    5
    1
    1
    0
    2
    1
    1
    3
    9
    6
    0
    12
    0
    7
    Rash erythematous
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    3
    Rash macular
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Scab
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Rash pruritic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    Rash papular
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Rash maculo-papular
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    1 / 11 (9.09%)
    2 / 15 (13.33%)
    1 / 9 (11.11%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    2 / 53 (3.77%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    0
    1
    1
    2
    1
    5
    0
    0
    0
    0
    1
    0
    2
    0
    0
    1
    0
    2
    Skin fissures
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    Skin lesion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    2 / 53 (3.77%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    0
    0
    0
    1
    0
    0
    0
    3
    0
    0
    0
    0
    0
    Skin hypopigmentation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Skin ulcer
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    1
    Swelling face
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    3 / 55 (5.45%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    3
    0
    1
    Renal and urinary disorders
    Bladder discomfort
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Acute kidney injury
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    1
    Dysuria
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    Haematuria
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    4
    0
    0
    1
    0
    1
    Incontinence
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Hydronephrosis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nocturia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    Proteinuria
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    2
    1
    0
    0
    0
    0
    0
    Renal injury
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Renal failure
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    1
    1
    0
    0
    Urinary incontinence
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Urinary retention
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    2 / 53 (3.77%)
    2 / 22 (9.09%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    1
    2
    2
    0
    1
    0
    1
    Hypothyroidism
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    3 / 15 (20.00%)
    1 / 9 (11.11%)
    1 / 14 (7.14%)
    1 / 6 (16.67%)
    2 / 7 (28.57%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    1 / 20 (5.00%)
    5 / 53 (9.43%)
    3 / 22 (13.64%)
    0 / 14 (0.00%)
    7 / 55 (12.73%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    0
    0
    1
    3
    1
    1
    1
    2
    1
    0
    1
    1
    5
    3
    0
    7
    0
    3
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Arthralgia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    1 / 11 (9.09%)
    3 / 15 (20.00%)
    1 / 9 (11.11%)
    1 / 14 (7.14%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    2 / 24 (8.33%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    1 / 20 (5.00%)
    5 / 53 (9.43%)
    5 / 22 (22.73%)
    0 / 14 (0.00%)
    4 / 55 (7.27%)
    0 / 1 (0.00%)
    4 / 50 (8.00%)
         occurrences all number
    0
    0
    1
    2
    4
    1
    2
    1
    3
    4
    0
    1
    1
    5
    9
    0
    5
    0
    4
    Back pain
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 9 (22.22%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    3 / 9 (33.33%)
    2 / 14 (14.29%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    3 / 24 (12.50%)
    1 / 1 (100.00%)
    1 / 10 (10.00%)
    3 / 20 (15.00%)
    4 / 53 (7.55%)
    3 / 22 (13.64%)
    0 / 14 (0.00%)
    5 / 55 (9.09%)
    0 / 1 (0.00%)
    4 / 50 (8.00%)
         occurrences all number
    0
    2
    1
    0
    1
    5
    2
    0
    1
    3
    1
    1
    4
    4
    3
    0
    7
    0
    4
    Flank pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    Bone pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    Groin pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Joint effusion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hypercreatinaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    1 / 11 (9.09%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    3
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Joint swelling
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    Muscular weakness
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 9 (22.22%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    1
    0
    1
    1
    0
    0
    0
    0
    1
    1
    0
    2
    0
    0
    Muscle spasms
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    2 / 7 (28.57%)
    0 / 11 (0.00%)
    3 / 15 (20.00%)
    2 / 9 (22.22%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    1 / 1 (100.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    2 / 53 (3.77%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    2
    0
    3
    3
    0
    0
    0
    0
    3
    0
    0
    3
    1
    0
    1
    0
    1
    Muscle contracture
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    2 / 9 (22.22%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    1 / 24 (4.17%)
    1 / 1 (100.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    3 / 22 (13.64%)
    0 / 14 (0.00%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    1
    0
    0
    0
    0
    3
    0
    0
    1
    2
    1
    0
    0
    0
    3
    0
    2
    0
    3
    Musculoskeletal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    4 / 53 (7.55%)
    3 / 22 (13.64%)
    0 / 14 (0.00%)
    3 / 55 (5.45%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    2
    0
    0
    0
    0
    1
    5
    3
    0
    3
    0
    2
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    2
    0
    0
    Myalgia
         subjects affected / exposed
    1 / 4 (25.00%)
    2 / 9 (22.22%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    2 / 20 (10.00%)
    2 / 53 (3.77%)
    2 / 22 (9.09%)
    3 / 14 (21.43%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    2
    2
    0
    0
    0
    1
    0
    1
    3
    0
    0
    2
    2
    3
    3
    2
    0
    0
    Neck mass
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Neck pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    2 / 15 (13.33%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    3 / 24 (12.50%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    7 / 53 (13.21%)
    4 / 22 (18.18%)
    2 / 14 (14.29%)
    7 / 55 (12.73%)
    0 / 1 (0.00%)
    5 / 50 (10.00%)
         occurrences all number
    0
    1
    0
    0
    3
    0
    1
    0
    0
    3
    0
    1
    0
    8
    4
    2
    8
    0
    5
    Pain in extremity
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 9 (22.22%)
    2 / 7 (28.57%)
    2 / 11 (18.18%)
    1 / 15 (6.67%)
    1 / 9 (11.11%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    1 / 20 (5.00%)
    2 / 53 (3.77%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    4 / 55 (7.27%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    2
    3
    2
    1
    2
    1
    0
    0
    1
    0
    1
    1
    2
    1
    0
    4
    0
    2
    Pain in jaw
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    2 / 11 (18.18%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    2 / 53 (3.77%)
    2 / 22 (9.09%)
    1 / 14 (7.14%)
    3 / 55 (5.45%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    1
    0
    0
    0
    2
    2
    1
    3
    0
    1
    Trismus
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    2 / 53 (3.77%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    2
    0
    0
    Spinal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Atypical pneumonia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Bronchitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    2 / 15 (13.33%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    2 / 53 (3.77%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    1
    0
    0
    0
    0
    0
    1
    0
    2
    1
    0
    1
    0
    0
    Candida infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    1 / 11 (9.09%)
    1 / 15 (6.67%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    2 / 53 (3.77%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    1
    1
    1
    2
    0
    0
    1
    0
    0
    0
    0
    2
    0
    0
    1
    0
    2
    Cat scratch disease
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Bacterial vaginosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Cystitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    2 / 22 (9.09%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    2
    0
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    1
    1
    0
    2
    0
    0
    Cellulitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    0
    4
    0
    0
    0
    0
    1
    0
    0
    0
    1
    Ear infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    Diverticulitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Folliculitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    1 / 1 (100.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Dental fistula
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Gastrointestinal candidiasis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Fungal infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    1 / 1 (100.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Herpes zoster
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    2 / 53 (3.77%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    2
    0
    1
    0
    0
    0
    Herpes virus infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Implant site cellulitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Mucosal infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Lung infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    1
    Nail infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Oral candidiasis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    1 / 53 (1.89%)
    2 / 22 (9.09%)
    0 / 14 (0.00%)
    5 / 55 (9.09%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    0
    0
    1
    0
    0
    1
    1
    3
    0
    5
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    3 / 53 (5.66%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    4 / 55 (7.27%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    8
    1
    0
    5
    0
    1
    Oral fungal infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Oral herpes
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    2 / 53 (3.77%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    2
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    1 / 22 (4.55%)
    3 / 14 (21.43%)
    4 / 55 (7.27%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    1
    3
    5
    0
    1
    Pneumonia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    1 / 11 (9.09%)
    2 / 15 (13.33%)
    2 / 9 (22.22%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    1 / 7 (14.29%)
    2 / 24 (8.33%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    2 / 53 (3.77%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
    4 / 55 (7.27%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    1
    0
    1
    2
    2
    0
    2
    1
    2
    0
    0
    1
    3
    1
    1
    5
    0
    1
    Peritonitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Oropharyngeal candidiasis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Skin infection
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 9 (22.22%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    2 / 53 (3.77%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    0
    1
    Skin candida
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    2 / 15 (13.33%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    1
    1
    0
    0
    3
    0
    1
    0
    0
    0
    0
    0
    1
    1
    0
    0
    6
    0
    0
    Sepsis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Staphylococcal infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Tooth abscess
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Trichomoniasis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    4 / 15 (26.67%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    3 / 10 (30.00%)
    0 / 20 (0.00%)
    4 / 53 (7.55%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    3 / 55 (5.45%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    9
    3
    0
    0
    1
    1
    0
    6
    0
    5
    0
    0
    11
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    1 / 7 (14.29%)
    1 / 11 (9.09%)
    1 / 15 (6.67%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    2 / 7 (28.57%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    2 / 53 (3.77%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    3 / 55 (5.45%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    1
    1
    2
    2
    0
    1
    2
    7
    0
    0
    0
    3
    3
    0
    4
    0
    0
    Vulvovaginal mycotic infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Cachexia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Appetite disorder
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Decreased appetite
         subjects affected / exposed
    1 / 4 (25.00%)
    5 / 9 (55.56%)
    1 / 7 (14.29%)
    2 / 11 (18.18%)
    5 / 15 (33.33%)
    4 / 9 (44.44%)
    3 / 14 (21.43%)
    1 / 6 (16.67%)
    4 / 7 (57.14%)
    4 / 24 (16.67%)
    1 / 1 (100.00%)
    3 / 10 (30.00%)
    6 / 20 (30.00%)
    11 / 53 (20.75%)
    8 / 22 (36.36%)
    6 / 14 (42.86%)
    9 / 55 (16.36%)
    1 / 1 (100.00%)
    4 / 50 (8.00%)
         occurrences all number
    1
    5
    1
    2
    5
    4
    3
    1
    5
    4
    2
    3
    6
    13
    11
    6
    9
    2
    4
    Dehydration
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    2 / 7 (28.57%)
    1 / 11 (9.09%)
    2 / 15 (13.33%)
    2 / 9 (22.22%)
    0 / 14 (0.00%)
    2 / 6 (33.33%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    2 / 53 (3.77%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    2
    2
    1
    2
    4
    0
    2
    0
    2
    0
    0
    1
    2
    0
    0
    0
    0
    2
    Hypercreatininaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hypercalcaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    9 / 53 (16.98%)
    3 / 22 (13.64%)
    2 / 14 (14.29%)
    4 / 55 (7.27%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    10
    3
    2
    6
    0
    2
    Failure to thrive
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    2 / 20 (10.00%)
    0 / 53 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    4
    0
    3
    1
    5
    0
    3
    Hyperphosphataemia
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 9 (22.22%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    1 / 20 (5.00%)
    2 / 53 (3.77%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    3
    0
    0
    1
    0
    5
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    1 / 53 (1.89%)
    0 / 22 (0.00%)
    1 / 14 (7.14%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    1
    2
    0
    0
    Hypocalcaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    2 / 9 (22.22%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    2 / 53 (3.77%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    2 / 55 (3.64%)
    0 / 1 (0.00%)
    2 / 50 (4.00%)
         occurrences all number
    0
    0
    0
    0
    1
    3
    0
    0
    0
    0
    0
    1
    0
    2
    0
    0
    3
    0
    2
    Hypocholesterolaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hyponatraemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    2 / 11 (18.18%)
    1 / 15 (6.67%)
    2 / 9 (22.22%)
    2 / 14 (14.29%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 24 (8.33%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    7 / 53 (13.21%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    5 / 55 (9.09%)
    0 / 1 (0.00%)
    7 / 50 (14.00%)
         occurrences all number
    0
    0
    0
    3
    1
    4
    3
    0
    0
    3
    0
    1
    0
    9
    1
    0
    6
    0
    8
    Hypomagnesaemia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    1 / 14 (7.14%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    2 / 10 (20.00%)
    0 / 20 (0.00%)
    3 / 53 (5.66%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    2
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    2
    0
    6
    1
    0
    1
    0
    5
    Hypokalaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 7 (14.29%)
    2 / 11 (18.18%)
    2 / 15 (13.33%)
    0 / 9 (0.00%)
    2 / 14 (14.29%)
    1 / 6 (16.67%)
    2 / 7 (28.57%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    9 / 53 (16.98%)
    3 / 22 (13.64%)
    1 / 14 (7.14%)
    6 / 55 (10.91%)
    0 / 1 (0.00%)
    4 / 50 (8.00%)
         occurrences all number
    0
    0
    1
    2
    3
    0
    3
    1
    2
    0
    0
    1
    0
    17
    8
    1
    8
    0
    5
    Hypophosphataemia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    2 / 15 (13.33%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    1 / 24 (4.17%)
    0 / 1 (0.00%)
    1 / 10 (10.00%)
    0 / 20 (0.00%)
    6 / 53 (11.32%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    1 / 55 (1.82%)
    0 / 1 (0.00%)
    3 / 50 (6.00%)
         occurrences all number
    0
    1
    0
    0
    2
    0
    0
    1
    0
    2
    0
    1
    0
    7
    1
    0
    2
    0
    6
    Iron deficiency
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    1 / 6 (16.67%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    0 / 50 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Vitamin B12 deficiency
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 7 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 14 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 24 (0.00%)
    0 / 1 (0.00%)
    0 / 10 (0.00%)
    0 / 20 (0.00%)
    0 / 53 (0.00%)
    0 / 22 (0.00%)
    0 / 14 (0.00%)
    0 / 55 (0.00%)
    0 / 1 (0.00%)
    1 / 50 (2.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Nov 2019
    This protocol amendment has been prepared globally for all patients currently enrolled in this study, with the exception of patients enrolled in Germany (Germany must use the Germany- specific protocol amendment 11.1, version 12.1, 13 Nov 2019). The key protocol amendment changes are as follows: • Amendment number and version number updated on the cover page and header. • Addition of pemphigoid as a potential risk for durvalumab in Section 1.3.2. • Revisions to Section 6.12 to provide additional guidance on continuation of patient’s treatment after last subject last visit for the primary endpoint. In addition, the actual study start date and the data cut-off date for primary endpoint were updated. • Revisions to Appendix I to align with the updated Toxicity Management Guidelines for durvalumab (MEDI4736) and tremelimumab issued based on CTCAE version 4.03 dated 17 October 2019. Please note: Appendix I has been replaced with an Annex to the protocol. • Minor formatting changes were made, and the table of contents were updated accordingly.
    08 May 2024
    This protocol amendment was prepared globally for all patients enrolled in this study at the time of its implementation. The key protocol amendment changes are as follows: • Amendment number and version number updated on the cover page and header. • Revision of Section 1.1 to reflect that AZD9150 (also known as danvatirsen) is owned by Flamingo Therapeutics. • Revision to Section 1.3.2 to delete the potential/identified risks associated with durvalumab and tremelimumab monotherapies as well as with durvalumab + tremelimumab combination therapy. The deleted text is now replaced with references to the durvalumab (MEDI4736) and tremelimumab Investigator’s Brochures (IBs) to continually refer to the most recent durvalumab and tremelimumab safety profiles in this protocol. • Revision of Sections 6.5, 6.9.6, 6.10, and 7.8 to remove all references to Syneos Health, who managed this study until 26 February 2024. References to Syneos Health are now updated with new Contract Research Organisation/AstraZeneca contacts, as applicable and sections re-worded for study management, safety reporting and medical monitoring. • Revision to Section 6.12 to update with post-study access-related text to allow study participants to transition to a roll-over or safety extension study if such study is available at the time of database lock or thereafter. • Revision to Section 6.12 to allow Investigators to switch participant(s) from combination therapy to durvalumab monotherapy at the flat dose of 1.5 g intravenously (IV) every 4 weeks (Q4W) during the continued treatment period. • Minor formatting, cross-linking, and editing changes were made, and the table of contents were updated accordingly.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue Nov 03 03:49:14 CET 2026 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA