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    Clinical Trial Results:
    A Phase 1/2 Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 701 Monotherapy, or in Combination With Pomalidomide, With and Without Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (ParadigMM-1B)

    Summary
    EudraCT number
    		 2017-001997-41
    Trial protocol
    		 DE   NL   BE  
    Global end of trial date
    30 Jun 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Jun 2024
    First version publication date
    14 Jun 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    20170122
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03287908
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Amgen Inc.
    Sponsor organisation address
    One Amgen Center Drive, Thousand Oaks, CA, United States,
    Public contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com
    Scientific contact
    IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.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
    Final
    Date of interim/final analysis
    30 Jun 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of the study was to evaluate the safety and tolerability of AMG 701 in participants with relapsed/refractory multiple myeloma (RRMM) to determine the maximum tolerated dose and/or recommended phase 2 dose (RP2D).
    Protection of trial subjects
    The study was conducted in accordance with the protocol and with the consensus of ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organizations of Medical Sciences International Ethical Guidelines, applicable International Conference on Harmonisation (ICH) Good Clinical Practice Guidelines, and applicable ICH laws and regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Nov 2017
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Scientific research
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 24
    Country: Number of subjects enrolled
    Canada: 6
    Country: Number of subjects enrolled
    Germany: 9
    Country: Number of subjects enrolled
    Japan: 8
    Country: Number of subjects enrolled
    Netherlands: 20
    Country: Number of subjects enrolled
    United States: 107
    Worldwide total number of subjects
    174
    EEA total number of subjects
    29
    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)
    88
    From 65 to 84 years
    86
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were enrolled at 28 study centers in 6 countries and participated from November 2017 to June 2023.

    Pre-assignment
    Screening details
    		 Participants were enrolled into sequential dose-exploration and dose-confirmation cohorts to receive AMG 701 monotherapy with different dose step scenarios. Doses ranged from Dose A to Dose O (lowest to highest).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1: AMG 701 Dose A
    Arm description
    		 AMG 701 Dose A was administered as a weekly intravenous (IV) infusion in a 4-week cycle with no step dosing.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG 701
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received IV doses of AMG 701.

    Arm title
    		 Cohort 2: AMG 701 Dose B
    Arm description
    		 AMG 701 Dose B was administered as a weekly IV infusion in a 4-week cycle with no step dosing.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG 701
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received IV doses of AMG 701.

    Arm title
    		 Cohort 3: AMG 701 Dose C
    Arm description
    		 AMG 701 Dose C was administered as a weekly IV infusion in a 4-week cycle with no step dosing.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG 701
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received IV doses of AMG 701.

    Arm title
    		 Cohort 4: AMG 701 Dose D
    Arm description
    		 AMG 701 Dose D was administered as a weekly IV infusion in a 4-week cycle with no step dosing.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG 701
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received IV doses of AMG 701.

    Arm title
    		 Cohort 5: AMG 701 Dose E
    Arm description
    		 AMG 701 Dose E was administered as a weekly IV infusion in a 4-week cycle with no step dosing.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG 701
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received IV doses of AMG 701.

    Arm title
    		 Cohort 6: AMG 701 Dose F
    Arm description
    		 AMG 701 Dose F was administered as a weekly IV infusion in a 4-week cycle with no step dosing.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG 701
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received IV doses of AMG 701.

    Arm title
    		 Cohort 7: AMG 701 Dose H
    Arm description
    		 AMG 701 Dose H was administered as a weekly IV infusion in a 4-week cycle with no step dosing.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG 701
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received IV doses of AMG 701.

    Arm title
    		 Cohort 8: AMG 701 Dose F/Dose G
    Arm description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on Cycle (C) 1 Day (D) 1 and AMG 701 Dose G weekly from C1D8 (4-week cycle).
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG 701
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received IV doses of AMG 701.

    Arm title
    		 Cohort 9: AMG 701 Dose F/Dose H
    Arm description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose H weekly from C1D8 (4-week cycle).
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG 701
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received IV doses of AMG 701.

    Arm title
    		 Cohort 9 extension (ext): AMG 701 Dose F/Dose H
    Arm description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose H weekly from C1D5 (4-week cycle).
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG 701
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received IV doses of AMG 701.

    Arm title
    		 Cohort 10: AMG 701 Dose F/Dose I
    Arm description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose I weekly from C1D8 (4-week cycle).
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG 701
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received IV doses of AMG 701.

    Arm title
    		 Cohort 10 ext: AMG 701 Dose F/Dose I
    Arm description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose I weekly from C1D5 (4-week cycle).
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG 701
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received IV doses of AMG 701.

    Arm title
    		 Cohort 11: AMG 701 Dose F/Dose J
    Arm description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose J weekly from C1D8 (4-week cycle).
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG 701
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received IV doses of AMG 701.

    Arm title
    		 Cohort 11 ext: AMG 701 Dose F/Dose J
    Arm description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose J weekly from C1D5 (4-week cycle).
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG 701
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received IV doses of AMG 701.

    Arm title
    		 Cohort 12: AMG 701 Dose F/Dose L
    Arm description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose L weekly from C1D8 (4-week cycle).
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG 701
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received IV doses of AMG 701.

    Arm title
    		 Cohort 12 ext: AMG 701 Dose F/Dose L
    Arm description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose L weekly from C1D3 (4-week cycle).
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG 701
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received IV doses of AMG 701.

    Arm title
    		 Cohort 13: AMG 701 Dose F/Dose M
    Arm description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose M weekly from C1D8 (4-week cycle).
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG 701
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received IV doses of AMG 701.

    Arm title
    		 Cohort 13 ext: AMG 701 Dose F/Dose M
    Arm description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose M weekly from C1D3 (4-week cycle).
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG 701
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received IV doses of AMG 701.

    Arm title
    		 Cohort 14: AMG 701 Dose F/Dose N
    Arm description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose N weekly from C1D8 (4-week cycle).
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG 701
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received IV doses of AMG 701.

    Arm title
    		 Cohort 14 ext: AMG 701 Dose F/Dose N
    Arm description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose N weekly from C1D3 (4-week cycle).
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG 701
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received IV doses of AMG 701.

    Arm title
    		 Cohort 15: AMG 701 Dose F/Dose O
    Arm description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose O weekly from C1D8 (4-week cycle).
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG 701
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received IV doses of AMG 701.

    Arm title
    		 eIV Cohort: AMG 701 Dose G/day (7-day eIV) + Dose N
    Arm description
    		 AMG 701 Dose G/day was administered as an extended IV (eIV) infusion over 7 days and participants received AMG 701 Dose N weekly from C1D8 (4-week cycle).
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG 701
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received IV doses of AMG 701.

    Arm title
    		 Cohort 14A: AMG 701 Dose F/Dose M/Dose N
    Arm description
    		 AMG 701 was administered as an IV infusion with two-step dosing. Participants received AMG 701 Dose F on C1D1, AMG 701 Dose M on C1D3, and AMG 701 Dose N weekly from C1D8 (4-week cycle).
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG 701
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received IV doses of AMG 701.

    Arm title
    		 Cohort 15A: AMG 701 Dose F/Dose M/Dose O
    Arm description
    		 AMG 701 was administered as an IV infusion with two-step dosing. Participants received AMG 701 Dose F on C1D1, AMG 701 Dose M on C1D3, and AMG 701 Dose O weekly from C1D8 (4-week cycle).
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG 701
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received IV doses of AMG 701.

    Arm title
    		 Cohort 15B Group 1: AMG 701 Dose F/Dose K/Dose O
    Arm description
    		 AMG 701 was administered as an IV infusion with two-step dosing. Participants received AMG 701 Dose F on C1D1, AMG 701 Dose K on C1D3, and AMG 701 Dose O weekly from C1D8 (4-week cycle). Group 1 included participants who did not receive a prior B-cell maturation antigen (BCMA) targeting therapy.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG 701
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received IV doses of AMG 701.

    Arm title
    		 Cohort 15C Group 1: AMG 701 Dose F/Dose J/Dose M/Dose O
    Arm description
    		 AMG 701 was administered as an IV infusion with three-step dosing. Participants received AMG 701 Dose F on C1D1, AMG 701 Dose J on C1D3, AMG 701 Dose M on C1D5, and AMG 701 Dose O weekly from C1D8 (4-week cycle). Group 1 included participants who did not receive a prior BCMA targeting therapy.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG 701
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received IV doses of AMG 701.

    Arm title
    		 Cohort 15C Group 2: AMG 701 Dose F/Dose J/Dose M/Dose O
    Arm description
    		 AMG 701 was administered as an IV infusion with three-step dosing. Participants received AMG 701 Dose F on C1D1, AMG 701 Dose J on C1D3, AMG 701 Dose M on C1D5, and AMG 701 Dose O weekly from C1D8 (4-week cycle). Group 2 included participants who had relapsed or were intolerant to prior BCMA targeting therapy.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AMG 701
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received IV doses of AMG 701.

    Number of subjects in period 1
    		Cohort 1: AMG 701 Dose A Cohort 2: AMG 701 Dose B Cohort 3: AMG 701 Dose C Cohort 4: AMG 701 Dose D Cohort 5: AMG 701 Dose E Cohort 6: AMG 701 Dose F Cohort 7: AMG 701 Dose H Cohort 8: AMG 701 Dose F/Dose G Cohort 9: AMG 701 Dose F/Dose H Cohort 9 extension (ext): AMG 701 Dose F/Dose H Cohort 10: AMG 701 Dose F/Dose I Cohort 10 ext: AMG 701 Dose F/Dose I Cohort 11: AMG 701 Dose F/Dose J Cohort 11 ext: AMG 701 Dose F/Dose J Cohort 12: AMG 701 Dose F/Dose L Cohort 12 ext: AMG 701 Dose F/Dose L Cohort 13: AMG 701 Dose F/Dose M Cohort 13 ext: AMG 701 Dose F/Dose M Cohort 14: AMG 701 Dose F/Dose N Cohort 14 ext: AMG 701 Dose F/Dose N Cohort 15: AMG 701 Dose F/Dose O eIV Cohort: AMG 701 Dose G/day (7-day eIV) + Dose N Cohort 14A: AMG 701 Dose F/Dose M/Dose N Cohort 15A: AMG 701 Dose F/Dose M/Dose O Cohort 15B Group 1: AMG 701 Dose F/Dose K/Dose O Cohort 15C Group 1: AMG 701 Dose F/Dose J/Dose M/Dose O Cohort 15C Group 2: AMG 701 Dose F/Dose J/Dose M/Dose O
    Started
    1
    1
    1
    3
    4
    4
    1
    4
    5
    3
    8
    3
    4
    3
    6
    5
    4
    6
    5
    9
    4
    4
    4
    8
    32
    32
    10
    Safety Analysis Set
    1
    1
    1
    3
    4
    4
    1
    4
    5
    3
    8
    3
    4
    3
    5
    5
    4
    6
    5
    9
    4
    4
    4
    8
    32
    31
    10
    Completed
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Not completed
    1
    1
    1
    3
    3
    4
    1
    4
    5
    3
    8
    3
    4
    3
    6
    5
    4
    6
    5
    9
    4
    4
    4
    8
    32
    32
    10
         Consent withdrawn by subject
    1
    -
    -
    -
    1
    -
    -
    -
    1
    -
    -
    -
    -
    -
    2
    1
    1
    -
    -
    2
    1
    -
    -
    -
    5
    3
    3
         Death
    -
    1
    1
    3
    2
    2
    1
    4
    4
    2
    7
    1
    2
    2
    1
    2
    3
    6
    4
    4
    2
    3
    2
    7
    11
    8
    4
         Sponsor decision
    -
    -
    -
    -
    -
    2
    -
    -
    -
    1
    1
    2
    2
    1
    3
    2
    -
    -
    1
    3
    1
    1
    2
    1
    16
    21
    3

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1: AMG 701 Dose A
    Reporting group description
    		 AMG 701 Dose A was administered as a weekly intravenous (IV) infusion in a 4-week cycle with no step dosing.

    Reporting group title
    Cohort 2: AMG 701 Dose B
    Reporting group description
    		 AMG 701 Dose B was administered as a weekly IV infusion in a 4-week cycle with no step dosing.

    Reporting group title
    Cohort 3: AMG 701 Dose C
    Reporting group description
    		 AMG 701 Dose C was administered as a weekly IV infusion in a 4-week cycle with no step dosing.

    Reporting group title
    Cohort 4: AMG 701 Dose D
    Reporting group description
    		 AMG 701 Dose D was administered as a weekly IV infusion in a 4-week cycle with no step dosing.

    Reporting group title
    Cohort 5: AMG 701 Dose E
    Reporting group description
    		 AMG 701 Dose E was administered as a weekly IV infusion in a 4-week cycle with no step dosing.

    Reporting group title
    Cohort 6: AMG 701 Dose F
    Reporting group description
    		 AMG 701 Dose F was administered as a weekly IV infusion in a 4-week cycle with no step dosing.

    Reporting group title
    Cohort 7: AMG 701 Dose H
    Reporting group description
    		 AMG 701 Dose H was administered as a weekly IV infusion in a 4-week cycle with no step dosing.

    Reporting group title
    Cohort 8: AMG 701 Dose F/Dose G
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on Cycle (C) 1 Day (D) 1 and AMG 701 Dose G weekly from C1D8 (4-week cycle).

    Reporting group title
    Cohort 9: AMG 701 Dose F/Dose H
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose H weekly from C1D8 (4-week cycle).

    Reporting group title
    Cohort 9 extension (ext): AMG 701 Dose F/Dose H
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose H weekly from C1D5 (4-week cycle).

    Reporting group title
    Cohort 10: AMG 701 Dose F/Dose I
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose I weekly from C1D8 (4-week cycle).

    Reporting group title
    Cohort 10 ext: AMG 701 Dose F/Dose I
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose I weekly from C1D5 (4-week cycle).

    Reporting group title
    Cohort 11: AMG 701 Dose F/Dose J
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose J weekly from C1D8 (4-week cycle).

    Reporting group title
    Cohort 11 ext: AMG 701 Dose F/Dose J
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose J weekly from C1D5 (4-week cycle).

    Reporting group title
    Cohort 12: AMG 701 Dose F/Dose L
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose L weekly from C1D8 (4-week cycle).

    Reporting group title
    Cohort 12 ext: AMG 701 Dose F/Dose L
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose L weekly from C1D3 (4-week cycle).

    Reporting group title
    Cohort 13: AMG 701 Dose F/Dose M
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose M weekly from C1D8 (4-week cycle).

    Reporting group title
    Cohort 13 ext: AMG 701 Dose F/Dose M
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose M weekly from C1D3 (4-week cycle).

    Reporting group title
    Cohort 14: AMG 701 Dose F/Dose N
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose N weekly from C1D8 (4-week cycle).

    Reporting group title
    Cohort 14 ext: AMG 701 Dose F/Dose N
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose N weekly from C1D3 (4-week cycle).

    Reporting group title
    Cohort 15: AMG 701 Dose F/Dose O
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose O weekly from C1D8 (4-week cycle).

    Reporting group title
    eIV Cohort: AMG 701 Dose G/day (7-day eIV) + Dose N
    Reporting group description
    		 AMG 701 Dose G/day was administered as an extended IV (eIV) infusion over 7 days and participants received AMG 701 Dose N weekly from C1D8 (4-week cycle).

    Reporting group title
    Cohort 14A: AMG 701 Dose F/Dose M/Dose N
    Reporting group description
    		 AMG 701 was administered as an IV infusion with two-step dosing. Participants received AMG 701 Dose F on C1D1, AMG 701 Dose M on C1D3, and AMG 701 Dose N weekly from C1D8 (4-week cycle).

    Reporting group title
    Cohort 15A: AMG 701 Dose F/Dose M/Dose O
    Reporting group description
    		 AMG 701 was administered as an IV infusion with two-step dosing. Participants received AMG 701 Dose F on C1D1, AMG 701 Dose M on C1D3, and AMG 701 Dose O weekly from C1D8 (4-week cycle).

    Reporting group title
    Cohort 15B Group 1: AMG 701 Dose F/Dose K/Dose O
    Reporting group description
    		 AMG 701 was administered as an IV infusion with two-step dosing. Participants received AMG 701 Dose F on C1D1, AMG 701 Dose K on C1D3, and AMG 701 Dose O weekly from C1D8 (4-week cycle). Group 1 included participants who did not receive a prior B-cell maturation antigen (BCMA) targeting therapy.

    Reporting group title
    Cohort 15C Group 1: AMG 701 Dose F/Dose J/Dose M/Dose O
    Reporting group description
    		 AMG 701 was administered as an IV infusion with three-step dosing. Participants received AMG 701 Dose F on C1D1, AMG 701 Dose J on C1D3, AMG 701 Dose M on C1D5, and AMG 701 Dose O weekly from C1D8 (4-week cycle). Group 1 included participants who did not receive a prior BCMA targeting therapy.

    Reporting group title
    Cohort 15C Group 2: AMG 701 Dose F/Dose J/Dose M/Dose O
    Reporting group description
    		 AMG 701 was administered as an IV infusion with three-step dosing. Participants received AMG 701 Dose F on C1D1, AMG 701 Dose J on C1D3, AMG 701 Dose M on C1D5, and AMG 701 Dose O weekly from C1D8 (4-week cycle). Group 2 included participants who had relapsed or were intolerant to prior BCMA targeting therapy.

    Reporting group values
    		 Cohort 1: AMG 701 Dose A Cohort 2: AMG 701 Dose B Cohort 3: AMG 701 Dose C Cohort 4: AMG 701 Dose D Cohort 5: AMG 701 Dose E Cohort 6: AMG 701 Dose F Cohort 7: AMG 701 Dose H Cohort 8: AMG 701 Dose F/Dose G Cohort 9: AMG 701 Dose F/Dose H Cohort 9 extension (ext): AMG 701 Dose F/Dose H Cohort 10: AMG 701 Dose F/Dose I Cohort 10 ext: AMG 701 Dose F/Dose I Cohort 11: AMG 701 Dose F/Dose J Cohort 11 ext: AMG 701 Dose F/Dose J Cohort 12: AMG 701 Dose F/Dose L Cohort 12 ext: AMG 701 Dose F/Dose L Cohort 13: AMG 701 Dose F/Dose M Cohort 13 ext: AMG 701 Dose F/Dose M Cohort 14: AMG 701 Dose F/Dose N Cohort 14 ext: AMG 701 Dose F/Dose N Cohort 15: AMG 701 Dose F/Dose O eIV Cohort: AMG 701 Dose G/day (7-day eIV) + Dose N Cohort 14A: AMG 701 Dose F/Dose M/Dose N Cohort 15A: AMG 701 Dose F/Dose M/Dose O Cohort 15B Group 1: AMG 701 Dose F/Dose K/Dose O Cohort 15C Group 1: AMG 701 Dose F/Dose J/Dose M/Dose O Cohort 15C Group 2: AMG 701 Dose F/Dose J/Dose M/Dose O Total
    Number of subjects
    		 1 1 1 3 4 4 1 4 5 3 8 3 4 3 6 5 4 6 5 9 4 4 4 8 32 32 10 174
    Age Categorical
    Units: Participants
        0-17 years
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        18-64 years
    		 1 1 1 2 3 2 0 2 5 1 5 0 1 1 5 2 2 1 4 3 1 1 3 3 16 14 8 88
        65-74 years
    		 0 0 0 1 1 1 1 1 0 2 2 2 2 2 1 3 2 4 1 4 2 2 1 4 11 18 2 70
        75-84 years
    		 0 0 0 0 0 1 0 1 0 0 1 1 1 0 0 0 0 1 0 2 1 1 0 1 5 0 0 16
        ≥ 85 years
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
    Age Continuous
    Units: years
        median (full range (min-max))
    		 55.0 (55 to 55) 63.0 (63 to 63) 48.0 (48 to 48) 61.0 (58 to 71) 55.0 (50 to 65) 64.5 (58 to 81) 69.0 (69 to 69) 68.5 (47 to 83) 53.0 (49 to 59) 71.0 (49 to 72) 62.5 (55 to 76) 73.0 (69 to 77) 70.0 (53 to 78) 65.0 (63 to 70) 53.5 (48 to 67) 70.0 (34 to 74) 62.0 (55 to 71) 68.0 (53 to 76) 57.0 (46 to 72) 67.0 (55 to 79) 72.0 (56 to 82) 70.0 (61 to 77) 50.5 (41 to 66) 67.0 (60 to 75) 65.0 (44 to 82) 65.0 (51 to 74) 62.0 (52 to 70) -
    Gender Categorical
    Units: Participants
        Female
    		 0 1 1 3 3 2 0 4 1 2 3 2 1 1 3 3 1 1 1 5 2 1 1 5 17 14 6 84
        Male
    		 1 0 0 0 1 2 1 0 4 1 5 1 3 2 3 2 3 5 4 4 2 3 3 3 15 18 4 90
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 2
        Asian
    		 0 0 0 0 0 0 0 0 0 0 0 0 1 1 0 0 0 0 0 1 1 0 0 0 3 2 1 10
        Black (or African American)
    		 0 0 0 0 0 0 0 0 0 0 3 1 0 0 2 1 1 1 0 0 1 1 2 1 1 2 1 18
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        White
    		 0 1 1 3 4 3 1 4 4 3 4 2 3 2 4 4 3 3 5 8 2 2 2 7 25 25 7 132
        Multiple
    		 0 0 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
        Other
    		 1 0 0 0 0 1 0 0 0 0 1 0 0 0 0 0 0 2 0 0 0 1 0 0 3 2 0 11
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1 0 0 0 0 0 0 1 0 0 2 0 0 0 0 0 0 2 0 0 0 1 0 0 0 2 0 9
        Not Hispanic or Latino
    		 0 1 1 3 4 4 1 3 5 3 6 3 4 3 6 5 4 4 5 9 4 3 4 8 32 30 10 165

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1: AMG 701 Dose A
    Reporting group description
    		 AMG 701 Dose A was administered as a weekly intravenous (IV) infusion in a 4-week cycle with no step dosing.

    Reporting group title
    Cohort 2: AMG 701 Dose B
    Reporting group description
    		 AMG 701 Dose B was administered as a weekly IV infusion in a 4-week cycle with no step dosing.

    Reporting group title
    Cohort 3: AMG 701 Dose C
    Reporting group description
    		 AMG 701 Dose C was administered as a weekly IV infusion in a 4-week cycle with no step dosing.

    Reporting group title
    Cohort 4: AMG 701 Dose D
    Reporting group description
    		 AMG 701 Dose D was administered as a weekly IV infusion in a 4-week cycle with no step dosing.

    Reporting group title
    Cohort 5: AMG 701 Dose E
    Reporting group description
    		 AMG 701 Dose E was administered as a weekly IV infusion in a 4-week cycle with no step dosing.

    Reporting group title
    Cohort 6: AMG 701 Dose F
    Reporting group description
    		 AMG 701 Dose F was administered as a weekly IV infusion in a 4-week cycle with no step dosing.

    Reporting group title
    Cohort 7: AMG 701 Dose H
    Reporting group description
    		 AMG 701 Dose H was administered as a weekly IV infusion in a 4-week cycle with no step dosing.

    Reporting group title
    Cohort 8: AMG 701 Dose F/Dose G
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on Cycle (C) 1 Day (D) 1 and AMG 701 Dose G weekly from C1D8 (4-week cycle).

    Reporting group title
    Cohort 9: AMG 701 Dose F/Dose H
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose H weekly from C1D8 (4-week cycle).

    Reporting group title
    Cohort 9 extension (ext): AMG 701 Dose F/Dose H
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose H weekly from C1D5 (4-week cycle).

    Reporting group title
    Cohort 10: AMG 701 Dose F/Dose I
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose I weekly from C1D8 (4-week cycle).

    Reporting group title
    Cohort 10 ext: AMG 701 Dose F/Dose I
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose I weekly from C1D5 (4-week cycle).

    Reporting group title
    Cohort 11: AMG 701 Dose F/Dose J
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose J weekly from C1D8 (4-week cycle).

    Reporting group title
    Cohort 11 ext: AMG 701 Dose F/Dose J
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose J weekly from C1D5 (4-week cycle).

    Reporting group title
    Cohort 12: AMG 701 Dose F/Dose L
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose L weekly from C1D8 (4-week cycle).

    Reporting group title
    Cohort 12 ext: AMG 701 Dose F/Dose L
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose L weekly from C1D3 (4-week cycle).

    Reporting group title
    Cohort 13: AMG 701 Dose F/Dose M
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose M weekly from C1D8 (4-week cycle).

    Reporting group title
    Cohort 13 ext: AMG 701 Dose F/Dose M
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose M weekly from C1D3 (4-week cycle).

    Reporting group title
    Cohort 14: AMG 701 Dose F/Dose N
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose N weekly from C1D8 (4-week cycle).

    Reporting group title
    Cohort 14 ext: AMG 701 Dose F/Dose N
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose N weekly from C1D3 (4-week cycle).

    Reporting group title
    Cohort 15: AMG 701 Dose F/Dose O
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose O weekly from C1D8 (4-week cycle).

    Reporting group title
    eIV Cohort: AMG 701 Dose G/day (7-day eIV) + Dose N
    Reporting group description
    		 AMG 701 Dose G/day was administered as an extended IV (eIV) infusion over 7 days and participants received AMG 701 Dose N weekly from C1D8 (4-week cycle).

    Reporting group title
    Cohort 14A: AMG 701 Dose F/Dose M/Dose N
    Reporting group description
    		 AMG 701 was administered as an IV infusion with two-step dosing. Participants received AMG 701 Dose F on C1D1, AMG 701 Dose M on C1D3, and AMG 701 Dose N weekly from C1D8 (4-week cycle).

    Reporting group title
    Cohort 15A: AMG 701 Dose F/Dose M/Dose O
    Reporting group description
    		 AMG 701 was administered as an IV infusion with two-step dosing. Participants received AMG 701 Dose F on C1D1, AMG 701 Dose M on C1D3, and AMG 701 Dose O weekly from C1D8 (4-week cycle).

    Reporting group title
    Cohort 15B Group 1: AMG 701 Dose F/Dose K/Dose O
    Reporting group description
    		 AMG 701 was administered as an IV infusion with two-step dosing. Participants received AMG 701 Dose F on C1D1, AMG 701 Dose K on C1D3, and AMG 701 Dose O weekly from C1D8 (4-week cycle). Group 1 included participants who did not receive a prior B-cell maturation antigen (BCMA) targeting therapy.

    Reporting group title
    Cohort 15C Group 1: AMG 701 Dose F/Dose J/Dose M/Dose O
    Reporting group description
    		 AMG 701 was administered as an IV infusion with three-step dosing. Participants received AMG 701 Dose F on C1D1, AMG 701 Dose J on C1D3, AMG 701 Dose M on C1D5, and AMG 701 Dose O weekly from C1D8 (4-week cycle). Group 1 included participants who did not receive a prior BCMA targeting therapy.

    Reporting group title
    Cohort 15C Group 2: AMG 701 Dose F/Dose J/Dose M/Dose O
    Reporting group description
    		 AMG 701 was administered as an IV infusion with three-step dosing. Participants received AMG 701 Dose F on C1D1, AMG 701 Dose J on C1D3, AMG 701 Dose M on C1D5, and AMG 701 Dose O weekly from C1D8 (4-week cycle). Group 2 included participants who had relapsed or were intolerant to prior BCMA targeting therapy.

    Subject analysis set title
    Cohort 9 and Cohort 9 ext Combined
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose H weekly from C1D5 (Cohort 9 ext) or C1D8 (Cohort 9) (4-week cycle).

    Subject analysis set title
    Cohort 10 and Cohort 10 ext Combined
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose I weekly from C1D5 (Cohort 10 ext) or C1D8 (Cohort 10) (4-week cycle).

    Subject analysis set title
    Cohort 11 and Cohort 11 ext Combined
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose J weekly from C1D5 (Cohort 11 ext) or C1D8 (Cohort 11) (4-week cycle).

    Subject analysis set title
    Cohort 12 and Cohort 12 ext Combined
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose L weekly from C1D3 (Cohort 12 ext) or C1D8 (Cohort 12) (4-week cycle).

    Subject analysis set title
    Cohort 13 and Cohort 13 ext Combined
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose M weekly from C1D3 (Cohort 13 ext) or C1D8 (Cohort 13) (4-week cycle).

    Subject analysis set title
    Cohort 14 and Cohort 14 ext Combined
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose N weekly from C1D3 (Cohort 14 ext) or C1D8 (Cohort 14) (4-week cycle).

    Primary: Number of Participants who Experienced a Dose Limiting Toxicity (DLT)

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    End point title
    		 Number of Participants who Experienced a Dose Limiting Toxicity (DLT) [1]
    End point description
    A DLT was any of the following during the DLT window, assessed by Common Terminology Criteria for Adverse Events v4.0: - Non-hematological adverse event (AE) ≥ grade 3, except: infection responding to treatment ≤ 48 hours; grade 3 fatigue/asthenia; headache resolving ≤ 72 hours ≤ grade 2; insomnia; grade 3 fever, nausea, vomiting or diarrhea resolving ≤ 72 hours; grade 3 laboratory parameters not clinically relevant and improving to grade ≤ 2 ≤ 72 hours or 7 days for parameters with long half-lives; grade 3/4 elevated lipase or amylase with no criteria suggestive of pancreatitis and improving to grade ≤ 2 ≤ 7 days; meeting criteria for Hy's Law. - Hematologic DLTs: febrile neutropenia grade 4 or grade 3 unless responding to treatment ≤ 48 hours; neutropenia grade 3 > 10 days or grade 4 > 5 days; thrombocytopenia grade 4 > 7 days or with hemorrhage or requiring transfusion or grade 3 with grade 3 hemorrhage; anemia grade 3 with symptoms or grade 4 without multiple myeloma.
    End point type
    Primary
    End point timeframe
    Day 1 up to 28 days (28 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: No comparative statistical analysis was planned for this endpoint.
    End point values
    		 Cohort 1: AMG 701 Dose A Cohort 2: AMG 701 Dose B Cohort 3: AMG 701 Dose C Cohort 4: AMG 701 Dose D Cohort 5: AMG 701 Dose E Cohort 6: AMG 701 Dose F Cohort 7: AMG 701 Dose H Cohort 8: AMG 701 Dose F/Dose G Cohort 9: AMG 701 Dose F/Dose H Cohort 9 extension (ext): AMG 701 Dose F/Dose H Cohort 10: AMG 701 Dose F/Dose I Cohort 10 ext: AMG 701 Dose F/Dose I Cohort 11: AMG 701 Dose F/Dose J Cohort 11 ext: AMG 701 Dose F/Dose J Cohort 12: AMG 701 Dose F/Dose L Cohort 12 ext: AMG 701 Dose F/Dose L Cohort 13: AMG 701 Dose F/Dose M Cohort 13 ext: AMG 701 Dose F/Dose M Cohort 14: AMG 701 Dose F/Dose N Cohort 14 ext: AMG 701 Dose F/Dose N Cohort 15: AMG 701 Dose F/Dose O eIV Cohort: AMG 701 Dose G/day (7-day eIV) + Dose N Cohort 14A: AMG 701 Dose F/Dose M/Dose N Cohort 15A: AMG 701 Dose F/Dose M/Dose O Cohort 15B Group 1: AMG 701 Dose F/Dose K/Dose O Cohort 15C Group 1: AMG 701 Dose F/Dose J/Dose M/Dose O Cohort 15C Group 2: AMG 701 Dose F/Dose J/Dose M/Dose O
    Number of subjects analysed
    1 [2]
    1 [3]
    1 [4]
    3 [5]
    3 [6]
    3 [7]
    1 [8]
    3 [9]
    5 [10]
    3 [11]
    7 [12]
    3 [13]
    3 [14]
    2 [15]
    5 [16]
    5 [17]
    4 [18]
    6 [19]
    4 [20]
    9 [21]
    4 [22]
    3 [23]
    3 [24]
    8 [25]
    10 [26]
    0 [27]
    9 [28]
    Units: participants
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    1
    0
    0
    2
    0
    1
    1
    0
    2
    1
    1
    0
    1
    0
    0
    Notes
    [2] - DLT analysis set included DLT-evaluable participants who experienced a DLT during the DLT window.
    [3] - DLT analysis set included DLT-evaluable participants who experienced a DLT during the DLT window.
    [4] - DLT analysis set included DLT-evaluable participants who experienced a DLT during the DLT window.
    [5] - DLT analysis set included DLT-evaluable participants who experienced a DLT during the DLT window.
    [6] - DLT analysis set included DLT-evaluable participants who experienced a DLT during the DLT window.
    [7] - DLT analysis set included DLT-evaluable participants who experienced a DLT during the DLT window.
    [8] - DLT analysis set included DLT-evaluable participants who experienced a DLT during the DLT window.
    [9] - DLT analysis set included DLT-evaluable participants who experienced a DLT during the DLT window.
    [10] - DLT analysis set included DLT-evaluable participants who experienced a DLT during the DLT window.
    [11] - DLT analysis set included DLT-evaluable participants who experienced a DLT during the DLT window.
    [12] - DLT analysis set included DLT-evaluable participants who experienced a DLT during the DLT window.
    [13] - DLT analysis set included DLT-evaluable participants who experienced a DLT during the DLT window.
    [14] - DLT analysis set included DLT-evaluable participants who experienced a DLT during the DLT window.
    [15] - DLT analysis set included DLT-evaluable participants who experienced a DLT during the DLT window.
    [16] - DLT analysis set included DLT-evaluable participants who experienced a DLT during the DLT window.
    [17] - DLT analysis set included DLT-evaluable participants who experienced a DLT during the DLT window.
    [18] - DLT analysis set included DLT-evaluable participants who experienced a DLT during the DLT window.
    [19] - DLT analysis set included DLT-evaluable participants who experienced a DLT during the DLT window.
    [20] - DLT analysis set included DLT-evaluable participants who experienced a DLT during the DLT window.
    [21] - DLT analysis set included DLT-evaluable participants who experienced a DLT during the DLT window.
    [22] - DLT analysis set included DLT-evaluable participants who experienced a DLT during the DLT window.
    [23] - DLT analysis set included DLT-evaluable participants who experienced a DLT during the DLT window.
    [24] - DLT analysis set included DLT-evaluable participants who experienced a DLT during the DLT window.
    [25] - DLT analysis set included DLT-evaluable participants who experienced a DLT during the DLT window.
    [26] - DLT analysis set included DLT-evaluable participants who experienced a DLT during the DLT window.
    [27] - DLT analysis set included DLT-evaluable participants who experienced a DLT during the DLT window.
    [28] - DLT analysis set included DLT-evaluable participants who experienced a DLT during the DLT window.
    No statistical analyses for this end point

    Primary: Number of Participants with Treatment-emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Participants with Treatment-emergent Adverse Events (TEAEs) [29]
    End point description
    An AE was defined as any untoward medical occurrence in a clinical trial participant. A TEAE was an AE that started on or after the first dose of investigational product (IP) (AMG 701) up to 33 days after the last dose of the IP or the end of study, whichever was earlier. Any clinically significant changes in vital signs, physical examinations, electrocardiograms, and clinical laboratory tests were included as TEAEs. A treatment-related AE was any TEAE that per investigator review had a reasonable possibility of being caused by AMG 701. The safety analysis set included all participants who were enrolled and received at least one dose of AMG 701.
    End point type
    Primary
    End point timeframe
    Cycle 1 Day 1 up to 30 days after the last dose of AMG 701; median duration was 4.1 months
    Notes
    [29] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No comparative statistical analysis was planned for this endpoint.
    End point values
    		 Cohort 1: AMG 701 Dose A Cohort 2: AMG 701 Dose B Cohort 3: AMG 701 Dose C Cohort 4: AMG 701 Dose D Cohort 5: AMG 701 Dose E Cohort 6: AMG 701 Dose F Cohort 7: AMG 701 Dose H Cohort 8: AMG 701 Dose F/Dose G Cohort 9: AMG 701 Dose F/Dose H Cohort 9 extension (ext): AMG 701 Dose F/Dose H Cohort 10: AMG 701 Dose F/Dose I Cohort 10 ext: AMG 701 Dose F/Dose I Cohort 11: AMG 701 Dose F/Dose J Cohort 11 ext: AMG 701 Dose F/Dose J Cohort 12: AMG 701 Dose F/Dose L Cohort 12 ext: AMG 701 Dose F/Dose L Cohort 13: AMG 701 Dose F/Dose M Cohort 13 ext: AMG 701 Dose F/Dose M Cohort 14: AMG 701 Dose F/Dose N Cohort 14 ext: AMG 701 Dose F/Dose N Cohort 15: AMG 701 Dose F/Dose O eIV Cohort: AMG 701 Dose G/day (7-day eIV) + Dose N Cohort 14A: AMG 701 Dose F/Dose M/Dose N Cohort 15A: AMG 701 Dose F/Dose M/Dose O Cohort 15B Group 1: AMG 701 Dose F/Dose K/Dose O Cohort 15C Group 1: AMG 701 Dose F/Dose J/Dose M/Dose O Cohort 15C Group 2: AMG 701 Dose F/Dose J/Dose M/Dose O
    Number of subjects analysed
    1
    1
    1
    3
    4
    4
    1
    4
    5
    3
    8
    3
    4
    3
    5
    5
    4
    6
    5
    9
    4
    4
    4
    8
    32
    31
    10
    Units: Participants
        Any TEAE
    1
    1
    1
    3
    4
    4
    1
    4
    5
    3
    8
    3
    4
    3
    5
    5
    4
    6
    5
    9
    4
    4
    4
    8
    32
    31
    10
        Any treatment-related TEAE
    0
    0
    1
    3
    4
    4
    1
    3
    4
    2
    7
    3
    4
    2
    5
    5
    4
    6
    5
    9
    4
    4
    4
    8
    32
    31
    10
    No statistical analyses for this end point

    Secondary: Maximum Serum Concentration of AMG 701 (Cmax) of AMG 701

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    End point title
    		 Maximum Serum Concentration of AMG 701 (Cmax) of AMG 701 [30]
    End point description
    The pharmacokinetic (PK) parameters were determined using non-compartmental approaches and considering the time-concentration profile over the complete sampling interval. The PK analysis set contained participants who had received at least one dose of AMG 701 and had at least one PK sample collected. These participants were evaluated for PK analysis unless the number of data points required for analysis was not enough, or significant protocol deviations had affected the data, or if key dosing or sampling information was missing. Data is presented for free serum AMG 701. 99999 indicates the value was not reported due to N = 0, or N = 1 and the standard deviation was not calculated.
    End point type
    Secondary
    End point timeframe
    Cohorts 1 and 2: C1D1, C1D8, and C1D15; Cohort 7: C1D1; Cohorts 8 and 15: C1D1, C1D15, and C1D22; All other cohorts: C1D1, C1D8, C1D15, and C1D22 (sampling pre-dose up to 120 hours post-dose; up to 144 hours post C1D8 for Cohort 16 only)
    Notes
    [30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for all cohorts are included in the endpoint, using a combination of reporting arms and subject analysis sets.
    End point values
    		 Cohort 1: AMG 701 Dose A Cohort 2: AMG 701 Dose B Cohort 3: AMG 701 Dose C Cohort 4: AMG 701 Dose D Cohort 5: AMG 701 Dose E Cohort 6: AMG 701 Dose F Cohort 7: AMG 701 Dose H Cohort 8: AMG 701 Dose F/Dose G Cohort 15: AMG 701 Dose F/Dose O eIV Cohort: AMG 701 Dose G/day (7-day eIV) + Dose N Cohort 14A: AMG 701 Dose F/Dose M/Dose N Cohort 15A: AMG 701 Dose F/Dose M/Dose O Cohort 15B Group 1: AMG 701 Dose F/Dose K/Dose O Cohort 15C Group 1: AMG 701 Dose F/Dose J/Dose M/Dose O Cohort 15C Group 2: AMG 701 Dose F/Dose J/Dose M/Dose O Cohort 9 and Cohort 9 ext Combined Cohort 10 and Cohort 10 ext Combined Cohort 11 and Cohort 11 ext Combined Cohort 12 and Cohort 12 ext Combined Cohort 13 and Cohort 13 ext Combined Cohort 14 and Cohort 14 ext Combined
    Number of subjects analysed
    1 [31]
    1 [32]
    1 [33]
    3 [34]
    4 [35]
    4 [36]
    1 [37]
    4 [38]
    4 [39]
    3 [40]
    4 [41]
    8 [42]
    12 [43]
    20 [44]
    9 [45]
    8 [46]
    11 [47]
    7 [48]
    10 [49]
    10 [50]
    14 [51]
    Units: ng/mL
    arithmetic mean (standard deviation)
        C1D1
    0.203 ( 99999 )
    0.072 ( 99999 )
    1.14 ( 99999 )
    0.384 ( 0.0558 )
    2.25 ( 1.63 )
    39.1 ( 63.5 )
    1.1 ( 99999 )
    40.5 ( 68.6 )
    14.7 ( 9.55 )
    15.7 ( 12.5 )
    1040 ( 926 )
    1250 ( 1650 )
    490 ( 693 )
    779 ( 784 )
    661 ( 1100 )
    9.63 ( 12.8 )
    7.54 ( 8.27 )
    35.9 ( 82.4 )
    462 ( 669 )
    476 ( 1080 )
    1510 ( 1580 )
        C1D8
    0.083 ( 99999 )
    0.082 ( 99999 )
    2.69 ( 99999 )
    0.381 ( 0.0237 )
    2.52 ( 1.92 )
    55.6 ( 88.7 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    769 ( 99999 )
    2310 ( 1850 )
    1980 ( 1650 )
    2170 ( 1810 )
    2810 ( 1360 )
    1980 ( 1780 )
    66 ( 126 )
    129 ( 198 )
    223 ( 341 )
    1110 ( 950 )
    213 ( 410 )
    2320 ( 1560 )
        C1D15
    0.322 ( 99999 )
    0.404 ( 99999 )
    1.98 ( 99999 )
    0.329 ( 0.065 )
    2.22 ( 2.07 )
    68.8 ( 109 )
    99999 ( 99999 )
    105 ( 143 )
    2750 ( 2070 )
    99999 ( 99999 )
    2360 ( 1960 )
    2680 ( 1420 )
    2740 ( 1230 )
    3040 ( 1320 )
    1470 ( 1700 )
    84 ( 153 )
    112 ( 177 )
    293 ( 540 )
    1440 ( 1130 )
    373 ( 506 )
    2490 ( 1500 )
        C1D22
    99999 ( 99999 )
    99999 ( 99999 )
    2.22 ( 99999 )
    0.341 ( 0.116 )
    2.45 ( 2.71 )
    82.8 ( 132 )
    99999 ( 99999 )
    105 ( 147 )
    2880 ( 1820 )
    99999 ( 99999 )
    2220 ( 1880 )
    3100 ( 1410 )
    2900 ( 1610 )
    3130 ( 1220 )
    195 ( 86.3 )
    106 ( 246 )
    81.3 ( 169 )
    402 ( 456 )
    1380 ( 1260 )
    806 ( 1130 )
    2320 ( 1600 )
    Notes
    [31] - (N=1, 1, 1, 0)
    [32] - (N=1, 1, 1, 0)
    [33] - (N=1, 1, 1, 1)
    [34] - (N=3, 3, 3, 3)
    [35] - (N=4, 4, 3, 3)
    [36] - (N=4, 3, 3, 3)
    [37] - (N=1, 0, 0, 0)
    [38] - (N=4, 0, 3, 3)
    [39] - (N=4, 0, 3, 4)
    [40] - (N=3, 1, 0, 0)
    [41] - (N=4, 3, 3, 3)
    [42] - (N=8, 4, 7, 7)
    [43] - (N=12, 8, 10, 8)
    [44] - (N=20, 13, 14, 14)
    [45] - (N=9, 5, 4, 2)
    [46] - (N=8, 8, 7, 8)
    [47] - (N=11, 11, 9, 8)
    [48] - (N=6, 7, 5, 5)
    [49] - (N=10, 8, 8, 6)
    [50] - (N=10, 8, 9, 9)
    [51] - (N=14, 12, 13, 11)
    No statistical analyses for this end point

    Secondary: Time to Cmax (Tmax) of AMG 701

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    End point title
    		 Time to Cmax (Tmax) of AMG 701 [52]
    End point description
    The PK parameters were determined using non-compartmental approaches and considering the time-concentration profile over the complete sampling interval. The PK analysis set contained participants who had received at least one dose of AMG 701 and had at least one PK sample collected. These participants were evaluated for PK analysis unless the number of data points required for analysis was not enough, or significant protocol deviations had affected the data, or if key dosing or sampling information was missing. Data is presented for free serum AMG 701. 99999 indicates the value was not reported due to N = 0, or N = 1 and standard deviation was not available.
    End point type
    Secondary
    End point timeframe
    Cohorts 1 and 2: C1D1, C1D8, and C1D15; Cohort 7: C1D1; Cohorts 8 and 15: C1D1, C1D15, and C1D22; All other cohorts: C1D1, C1D8, C1D15, and C1D22 (sampling pre-dose up to 120 hours post-dose; up to 144 hours post C1D8 for Cohort 16 only)
    Notes
    [52] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for all cohorts are included in the endpoint, using a combination of reporting arms and subject analysis sets.
    End point values
    		 Cohort 1: AMG 701 Dose A Cohort 2: AMG 701 Dose B Cohort 3: AMG 701 Dose C Cohort 4: AMG 701 Dose D Cohort 5: AMG 701 Dose E Cohort 6: AMG 701 Dose F Cohort 7: AMG 701 Dose H Cohort 8: AMG 701 Dose F/Dose G Cohort 15: AMG 701 Dose F/Dose O eIV Cohort: AMG 701 Dose G/day (7-day eIV) + Dose N Cohort 14A: AMG 701 Dose F/Dose M/Dose N Cohort 15A: AMG 701 Dose F/Dose M/Dose O Cohort 15B Group 1: AMG 701 Dose F/Dose K/Dose O Cohort 15C Group 1: AMG 701 Dose F/Dose J/Dose M/Dose O Cohort 15C Group 2: AMG 701 Dose F/Dose J/Dose M/Dose O Cohort 9 and Cohort 9 ext Combined Cohort 10 and Cohort 10 ext Combined Cohort 11 and Cohort 11 ext Combined Cohort 12 and Cohort 12 ext Combined Cohort 13 and Cohort 13 ext Combined Cohort 14 and Cohort 14 ext Combined
    Number of subjects analysed
    1 [53]
    1 [54]
    1 [55]
    3 [56]
    4 [57]
    4 [58]
    1 [59]
    4 [60]
    4 [61]
    3 [62]
    4 [63]
    8 [64]
    12 [65]
    20 [66]
    9 [67]
    8 [68]
    11 [69]
    7 [70]
    10 [71]
    10 [72]
    14 [73]
    Units: hours
    median (full range (min-max))
        C1D1
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 1)
    1 (1 to 2)
    1.5 (1 to 8)
    2.5 (1 to 4)
    2 (2 to 2)
    2 (1 to 8)
    1.5 (1 to 2)
    120 (72 to 168)
    49 (49 to 49)
    49 (49 to 50)
    49 (2 to 60)
    98 (1 to 240)
    168 (49 to 240)
    1 (1 to 12)
    2 (1 to 12)
    1 (1 to 8)
    36.5 (1 to 50)
    49.5 (1 to 56)
    49 (1 to 56)
        C1D8
    168 (168 to 168)
    2 (2 to 2)
    1 (1 to 1)
    1 (1 to 2)
    1 (1 to 6)
    2 (1 to 12)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    2 (2 to 2)
    1 (1 to 2)
    1 (1 to 8)
    1 (1 to 24)
    2 (1 to 48)
    6 (1 to 8)
    1 (1 to 4)
    2 (1 to 2)
    1 (1 to 2)
    1.5 (1 to 4)
    1 (1 to 6)
    2 (1 to 8)
        C1D15
    2 (2 to 2)
    2 (2 to 2)
    1 (1 to 1)
    1 (1 to 2)
    1 (1 to 24)
    1 (1 to 12)
    99999 (99999 to 99999)
    1 (1 to 2)
    2 (1 to 2)
    99999 (99999 to 99999)
    2 (1 to 2)
    2 (1 to 8)
    1.5 (1 to 48)
    4 (1 to 48)
    4.5 (1 to 24)
    1 (1 to 2)
    1 (1 to 24)
    1 (1 to 2)
    2 (1 to 2)
    1 (1 to 2)
    2 (1 to 8)
        C1D22
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    1 (1 to 1)
    1 (1 to 2)
    1 (1 to 4)
    1 (1 to 1)
    99999 (99999 to 99999)
    1 (1 to 1)
    2 (2 to 12)
    99999 (99999 to 99999)
    2 (1 to 2)
    2 (1 to 12)
    3 (1 to 48)
    8 (1 to 48)
    5 (2 to 8)
    1 (1 to 12)
    1 (1 to 4)
    1 (1 to 2)
    1 (1 to 2)
    1 (1 to 2)
    2 (1 to 4)
    Notes
    [53] - (N=1, 1, 1, 0)
    [54] - (N=1, 1, 1, 0)
    [55] - (N=1, 1, 1, 1)
    [56] - (N=3, 3, 3, 3)
    [57] - (N=4, 4, 3, 3)
    [58] - (N=4, 3, 3, 3)
    [59] - (N=1, 0, 0, 0)
    [60] - (N=4, 0, 3, 3)
    [61] - (N=4, 0, 3, 4)
    [62] - (N=3, 1, 0, 0)
    [63] - (N=4, 3, 3, 3)
    [64] - (N=8, 4, 7, 7)
    [65] - (N=12, 8, 10, 8)
    [66] - (N=20, 13, 14, 14)
    [67] - (N=9, 5, 4, 2)
    [68] - (N=8, 8, 7, 8)
    [69] - (N=11, 11, 9, 8)
    [70] - (N=6, 7, 5, 5)
    [71] - (N=10, 8, 8, 6)
    [72] - (N=10, 8, 9, 9)
    [73] - (N=14, 12, 13, 11)
    No statistical analyses for this end point

    Secondary: Area Under the Concentration-time Curve from Time 0 to 168 Hours (AUC168) for AMG 701

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    End point title
    		 Area Under the Concentration-time Curve from Time 0 to 168 Hours (AUC168) for AMG 701 [74]
    End point description
    The PK parameters were determined using non-compartmental approaches and considering the time-concentration profile over the complete sampling interval. The PK analysis set contained participants who had received at least one dose of AMG 701 and had at least one PK sample collected. These participants were evaluated for PK analysis unless the number of data points required for analysis was not enough, or significant protocol deviations had affected the data, or if key dosing or sampling information was missing. Data is presented for free serum AMG 701. 99999 indicates the value was not reported due to N = 0, or N = 1 the standard deviation was not calculated.
    End point type
    Secondary
    End point timeframe
    Cohorts 1 and 2: C1D1, C1D8, and C1D15; Cohort 7: C1D1; Cohorts 8 and 15: C1D1, C1D15, and C1D22; All other cohorts: C1D1, C1D8, C1D15, and C1D22 (sampling pre-dose up to 120 hours post-dose; up to 144 hours post C1D8 for Cohort 16 only)
    Notes
    [74] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for all cohorts are included in the endpoint, using a combination of reporting arms and subject analysis sets.
    End point values
    		 Cohort 1: AMG 701 Dose A Cohort 2: AMG 701 Dose B Cohort 3: AMG 701 Dose C Cohort 4: AMG 701 Dose D Cohort 5: AMG 701 Dose E Cohort 6: AMG 701 Dose F Cohort 7: AMG 701 Dose H Cohort 8: AMG 701 Dose F/Dose G Cohort 15: AMG 701 Dose F/Dose O eIV Cohort: AMG 701 Dose G/day (7-day eIV) + Dose N Cohort 14A: AMG 701 Dose F/Dose M/Dose N Cohort 15A: AMG 701 Dose F/Dose M/Dose O Cohort 15B Group 1: AMG 701 Dose F/Dose K/Dose O Cohort 15C Group 1: AMG 701 Dose F/Dose J/Dose M/Dose O Cohort 15C Group 2: AMG 701 Dose F/Dose J/Dose M/Dose O Cohort 9 and Cohort 9 ext Combined Cohort 10 and Cohort 10 ext Combined Cohort 11 and Cohort 11 ext Combined Cohort 12 and Cohort 12 ext Combined Cohort 13 and Cohort 13 ext Combined Cohort 14 and Cohort 14 ext Combined
    Number of subjects analysed
    1 [75]
    1 [76]
    1 [77]
    3 [78]
    4 [79]
    4 [80]
    1 [81]
    4 [82]
    4 [83]
    1 [84]
    4 [85]
    8 [86]
    12 [87]
    20 [88]
    9 [89]
    8 [90]
    11 [91]
    7 [92]
    9 [93]
    10 [94]
    13 [95]
    Units: hr*ng/mL
    arithmetic mean (standard deviation)
        C1D1
    5.99 ( 99999 )
    0.901 ( 99999 )
    59.1 ( 99999 )
    26.1 ( 7.15 )
    141 ( 111 )
    1440 ( 2060 )
    39.8 ( 99999 )
    1660 ( 1970 )
    695 ( 433 )
    2300 ( 99999 )
    27700 ( 37100 )
    50500 ( 74600 )
    17900 ( 32200 )
    31000 ( 42700 )
    29700 ( 63200 )
    437 ( 444 )
    366 ( 353 )
    208 ( 254 )
    21600 ( 35200 )
    21700 ( 57800 )
    68400 ( 71600 )
        C1D8
    3.98 ( 99999 )
    2.04 ( 99999 )
    140 ( 99999 )
    31.3 ( 6.5 )
    99999 ( 99999 )
    2670 ( 4070 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    54900 ( 99999 )
    122000 ( 117000 )
    71700 ( 92000 )
    84800 ( 120000 )
    147000 ( 129000 )
    88100 ( 155000 )
    1570 ( 2150 )
    4290 ( 7230 )
    4520 ( 6320 )
    54500 ( 70700 )
    4520 ( 5670 )
    135000 ( 121000 )
        C1D15
    25.7 ( 99999 )
    18.6 ( 99999 )
    137 ( 99999 )
    28.4 ( 13.1 )
    99999 ( 99999 )
    4360 ( 6820 )
    99999 ( 99999 )
    4230 ( 5570 )
    213000 ( 179000 )
    99999 ( 99999 )
    146000 ( 131000 )
    177000 ( 198000 )
    185000 ( 189000 )
    212000 ( 174000 )
    151000 ( 238000 )
    2050 ( 2620 )
    3120 ( 3770 )
    6240 ( 11100 )
    79900 ( 95400 )
    6930 ( 6990 )
    157000 ( 138000 )
        C1D22
    99999 ( 99999 )
    99999 ( 99999 )
    132 ( 99999 )
    29.5 ( 13.4 )
    99999 ( 99999 )
    5230 ( 8180 )
    99999 ( 99999 )
    4170 ( 5490 )
    207000 ( 190000 )
    99999 ( 99999 )
    188000 ( 161000 )
    236000 ( 181000 )
    208000 ( 181000 )
    288000 ( 201000 )
    11900 ( 3080 )
    2060 ( 3470 )
    2490 ( 3980 )
    9410 ( 11000 )
    91000 ( 114000 )
    30900 ( 63600 )
    157000 ( 147000 )
    Notes
    [75] - (N=1, 1, 1, 0)
    [76] - (N=1, 1, 1, 0)
    [77] - (N=1, 1, 1, 1)
    [78] - (N=3, 3, 3, 3)
    [79] - (N=4, 0, 0, 0)
    [80] - (N=4, 3, 3, 3)
    [81] - (N=1, 0, 0, 0)
    [82] - (N=3, 0, 3, 3)
    [83] - (N=4, 0, 3, 4)
    [84] - (N=1, 1, 0, 0)
    [85] - (N=4, 3, 3, 3)
    [86] - (N=8, 4, 7, 7)
    [87] - (N=11, 8, 10, 8)
    [88] - (N=20, 12, 14, 14)
    [89] - (N=9, 4, 3, 2)
    [90] - (N=7, 8, 7, 8)
    [91] - (N=11, 11, 9, 8)
    [92] - (N=6, 7, 5, 5)
    [93] - (N=9, 8, 8, 6)
    [94] - (N=10, 8, 9, 9)
    [95] - (N=13, 12, 13, 11)
    No statistical analyses for this end point

    Secondary: Best Overall Response (BOR) According to International Working Group Response Criteria for Multiple Myeloma (IMWG-URC)

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    End point title
    		 Best Overall Response (BOR) According to International Working Group Response Criteria for Multiple Myeloma (IMWG-URC)
    End point description
    BOR was the best observed disease response per IMWG-URC: • stringent complete response (sCR): complete response (CR) criteria, normal serum free light chain ratio and no clonal cells in BM; • CR: Negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, < 5% plasma cells in bone marrow (BM); • very good partial response (VGPR): Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level < 100 mg/24-h); • PR: ≥ 50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or to < 200 mg/24-h; • minor response (MR): 25–49% reduction of serum M-protein and 50–89% in 24-h urinary M-protein; • stable disease (SD): not meeting criteria for sCR, VGPR, PR, MR or Progressive Disease (PD); • PD: ≥ 25% increase in serum or urine M-protein, new bone lesions, ≥ 50% increase in circulating plasma cells. Safety analysis set included all enrolled participants who received at least one dose of study treatment.
    End point type
    Secondary
    End point timeframe
    C1D1 to the earliest of: start of new multiple myeloma therapy, disease progression per IMWG-URC, death, or consent withdrawal; median time on study was 12.6 months.
    End point values
    		 Cohort 1: AMG 701 Dose A Cohort 2: AMG 701 Dose B Cohort 3: AMG 701 Dose C Cohort 4: AMG 701 Dose D Cohort 5: AMG 701 Dose E Cohort 6: AMG 701 Dose F Cohort 7: AMG 701 Dose H Cohort 8: AMG 701 Dose F/Dose G Cohort 9: AMG 701 Dose F/Dose H Cohort 9 extension (ext): AMG 701 Dose F/Dose H Cohort 10: AMG 701 Dose F/Dose I Cohort 10 ext: AMG 701 Dose F/Dose I Cohort 11: AMG 701 Dose F/Dose J Cohort 11 ext: AMG 701 Dose F/Dose J Cohort 12: AMG 701 Dose F/Dose L Cohort 12 ext: AMG 701 Dose F/Dose L Cohort 13: AMG 701 Dose F/Dose M Cohort 13 ext: AMG 701 Dose F/Dose M Cohort 14: AMG 701 Dose F/Dose N Cohort 14 ext: AMG 701 Dose F/Dose N Cohort 15: AMG 701 Dose F/Dose O eIV Cohort: AMG 701 Dose G/day (7-day eIV) + Dose N Cohort 14A: AMG 701 Dose F/Dose M/Dose N Cohort 15A: AMG 701 Dose F/Dose M/Dose O Cohort 15B Group 1: AMG 701 Dose F/Dose K/Dose O Cohort 15C Group 1: AMG 701 Dose F/Dose J/Dose M/Dose O Cohort 15C Group 2: AMG 701 Dose F/Dose J/Dose M/Dose O
    Number of subjects analysed
    1
    1
    1
    3
    4
    4
    1
    4
    5
    3
    8
    3
    4
    3
    5
    5
    4
    6
    5
    9
    4
    4
    4
    8
    32
    31
    10
    Units: Participants
        sCR
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    1
    1
    1
    0
    1
    0
    1
    0
    0
    0
    1
    7
    8
    0
        CR
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    3
    1
    1
    2
    2
    6
    7
    2
        VGPR
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    1
    0
    1
    5
    7
    2
        PR
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    2
    1
    1
    0
    0
    0
    2
    1
    2
    1
        MR
    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
    1
    0
        SD
    0
    0
    1
    0
    0
    0
    0
    2
    3
    2
    5
    1
    1
    0
    1
    2
    1
    2
    2
    3
    2
    0
    0
    2
    5
    3
    1
        PD
    0
    0
    0
    2
    3
    2
    0
    0
    2
    1
    0
    1
    1
    1
    0
    1
    3
    1
    0
    1
    0
    0
    0
    0
    3
    3
    4
        Not evaluable
    1
    1
    0
    1
    1
    1
    1
    2
    0
    0
    1
    0
    1
    1
    1
    0
    0
    0
    1
    0
    0
    2
    2
    0
    5
    0
    0
    No statistical analyses for this end point

    Secondary: Overall Response Rate (ORR) per IMWG-URC

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    End point title
    		 Overall Response Rate (ORR) per IMWG-URC
    End point description
    ORR is the percentage of analysis set participants in each treatment group with a best overall response of sCR, CR, VGPR, or PR per IMWG-UCR. • sCR: CR and normal serum free light chain ratio and no clonal cells in BM; • CR: Negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, < 5% plasma cells in BM; • VGPR: Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level < 100 mg/24-h); • PR: ≥ 50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or to < 200 mg/24-h. Safety analysis set included all enrolled participants who received at least one dose of study treatment.
    End point type
    Secondary
    End point timeframe
    C1D1 to the earliest of: start of new multiple myeloma therapy, disease progression per IMWG-URC, death, or consent withdrawal; median time on study was 12.6 months.
    End point values
    		 Cohort 1: AMG 701 Dose A Cohort 2: AMG 701 Dose B Cohort 3: AMG 701 Dose C Cohort 4: AMG 701 Dose D Cohort 5: AMG 701 Dose E Cohort 6: AMG 701 Dose F Cohort 7: AMG 701 Dose H Cohort 8: AMG 701 Dose F/Dose G Cohort 9: AMG 701 Dose F/Dose H Cohort 9 extension (ext): AMG 701 Dose F/Dose H Cohort 10: AMG 701 Dose F/Dose I Cohort 10 ext: AMG 701 Dose F/Dose I Cohort 11: AMG 701 Dose F/Dose J Cohort 11 ext: AMG 701 Dose F/Dose J Cohort 12: AMG 701 Dose F/Dose L Cohort 12 ext: AMG 701 Dose F/Dose L Cohort 13: AMG 701 Dose F/Dose M Cohort 13 ext: AMG 701 Dose F/Dose M Cohort 14: AMG 701 Dose F/Dose N Cohort 14 ext: AMG 701 Dose F/Dose N Cohort 15: AMG 701 Dose F/Dose O eIV Cohort: AMG 701 Dose G/day (7-day eIV) + Dose N Cohort 14A: AMG 701 Dose F/Dose M/Dose N Cohort 15A: AMG 701 Dose F/Dose M/Dose O Cohort 15B Group 1: AMG 701 Dose F/Dose K/Dose O Cohort 15C Group 1: AMG 701 Dose F/Dose J/Dose M/Dose O Cohort 15C Group 2: AMG 701 Dose F/Dose J/Dose M/Dose O
    Number of subjects analysed
    1
    1
    1
    3
    4
    4
    1
    4
    5
    3
    8
    3
    4
    3
    5
    5
    4
    6
    5
    9
    4
    4
    4
    8
    32
    31
    10
    Units: percentage of participants
        number (confidence interval 95%)
    0.0 (0.0 to 97.5)
    0.0 (0.0 to 97.5)
    0.0 (0.0 to 97.5)
    0.0 (0.0 to 70.8)
    0.0 (0.0 to 60.2)
    25.0 (0.6 to 80.6)
    0.0 (0.0 to 97.5)
    0.0 (0.0 to 60.2)
    0.0 (0.0 to 52.2)
    0.0 (0.0 to 70.8)
    25.0 (3.2 to 65.1)
    33.3 (0.8 to 90.6)
    25.0 (0.6 to 80.6)
    33.3 (0.8 to 90.6)
    40.0 (5.3 to 85.3)
    40.0 (5.3 to 85.3)
    0.0 (0.0 to 60.2)
    50.0 (11.8 to 88.2)
    40.0 (5.3 to 85.3)
    55.6 (21.2 to 86.3)
    50.0 (6.8 to 93.2)
    50.0 (6.8 to 93.2)
    50.0 (6.8 to 93.2)
    75.0 (34.9 to 96.8)
    59.4 (40.6 to 76.3)
    77.4 (58.9 to 90.4)
    50.0 (18.7 to 81.3)
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR) According to IMWG-URC

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    End point title
    		 Duration of Response (DOR) According to IMWG-URC
    End point description
    DOR was calculated as (date of first confirmed PD assessment or death or censoring - date of the first observation indicating PR [or better] + 1) / 30.4375. PD: ≥ 25% increase in serum or urine M-protein, new bone lesions, ≥ 50% increase in circulating plasma cells. 95% confidence intervals (CIs) were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. 99999 = value was not evaluable. Safety analysis set included all enrolled participants who received at least one dose of study treatment. Data is included for participants who died or had PD.
    End point type
    Secondary
    End point timeframe
    C1D1 to the earliest of: start of new multiple myeloma therapy, disease progression per IMWG-URC, death, or consent withdrawal; median time on study was 12.6 months.
    End point values
    		 Cohort 1: AMG 701 Dose A Cohort 2: AMG 701 Dose B Cohort 3: AMG 701 Dose C Cohort 4: AMG 701 Dose D Cohort 5: AMG 701 Dose E Cohort 6: AMG 701 Dose F Cohort 7: AMG 701 Dose H Cohort 8: AMG 701 Dose F/Dose G Cohort 9: AMG 701 Dose F/Dose H Cohort 9 extension (ext): AMG 701 Dose F/Dose H Cohort 10: AMG 701 Dose F/Dose I Cohort 10 ext: AMG 701 Dose F/Dose I Cohort 11: AMG 701 Dose F/Dose J Cohort 11 ext: AMG 701 Dose F/Dose J Cohort 12: AMG 701 Dose F/Dose L Cohort 12 ext: AMG 701 Dose F/Dose L Cohort 13: AMG 701 Dose F/Dose M Cohort 13 ext: AMG 701 Dose F/Dose M Cohort 14: AMG 701 Dose F/Dose N Cohort 14 ext: AMG 701 Dose F/Dose N Cohort 15: AMG 701 Dose F/Dose O eIV Cohort: AMG 701 Dose G/day (7-day eIV) + Dose N Cohort 14A: AMG 701 Dose F/Dose M/Dose N Cohort 15A: AMG 701 Dose F/Dose M/Dose O Cohort 15B Group 1: AMG 701 Dose F/Dose K/Dose O Cohort 15C Group 1: AMG 701 Dose F/Dose J/Dose M/Dose O Cohort 15C Group 2: AMG 701 Dose F/Dose J/Dose M/Dose O
    Number of subjects analysed
    0 [96]
    0 [97]
    0 [98]
    0 [99]
    0 [100]
    1
    0 [101]
    0 [102]
    0 [103]
    0 [104]
    2
    1
    1
    1
    2
    2
    0 [105]
    3
    2
    5
    2
    2
    2
    6
    19
    24
    5
    Units: months
        median (confidence interval 95%)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    99999 (99999 to 99999)
    ( to )
    ( to )
    ( to )
    ( to )
    5.6 (3.7 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (36.6 to 99999)
    ( to )
    18.1 (0.99999 to 99999)
    99999 (12.1 to 99999)
    99999 (25.4 to 99999)
    99999 (5.6 to 99999)
    99999 (3.5 to 99999)
    99999 (22.3 to 99999)
    8.5 (4.6 to 99999)
    99999 (15.9 to 99999)
    99999 (9.8 to 99999)
    10.2 (-99999 to 99999)
    Notes
    [96] - No participants died or had PD.
    [97] - No participants died or had PD.
    [98] - No participants died or had PD.
    [99] - No participants died or had PD.
    [100] - No participants died or had PD.
    [101] - No participants died or had PD.
    [102] - No participants died or had PD.
    [103] - No participants died or had PD.
    [104] - No participants died or had PD.
    [105] - No participants died or had PD.
    No statistical analyses for this end point

    Secondary: Time to Response According to IMWG-UCR

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    End point title
    		 Time to Response According to IMWG-UCR
    End point description
    Time to response was calculated as (date of first confirmed sCR/CR/VGPR/PR - first dose date + 1) / 30.4375. • sCR: CR and normal serum free light chain ratio and no clonal cells in BM; • CR: Negative immunofixation on serum and urine, soft tissue plasmacytomas disappearance, < 5% plasma cells in BM; • VGPR: Serum and urine M-protein detectable by immunofixation or ≥ 90% reduction in serum M-protein (urine M-protein level < 100 mg/24-h); • PR: ≥ 50% reduction of serum M-protein and 24-h urinary M-protein by ≥ 90% or to < 200 mg/24-h. Safety analysis set included all enrolled participants who received at least one dose of study treatment. Data is presented for participants with a response of sCR, CR, VGPR or PR.
    End point type
    Secondary
    End point timeframe
    C1D1 to the earliest of: start of new multiple myeloma therapy, disease progression per IMWG-URC, death, or consent withdrawal; median time on study was 12.6 months.
    End point values
    		 Cohort 1: AMG 701 Dose A Cohort 2: AMG 701 Dose B Cohort 3: AMG 701 Dose C Cohort 4: AMG 701 Dose D Cohort 5: AMG 701 Dose E Cohort 6: AMG 701 Dose F Cohort 7: AMG 701 Dose H Cohort 8: AMG 701 Dose F/Dose G Cohort 9: AMG 701 Dose F/Dose H Cohort 9 extension (ext): AMG 701 Dose F/Dose H Cohort 10: AMG 701 Dose F/Dose I Cohort 10 ext: AMG 701 Dose F/Dose I Cohort 11: AMG 701 Dose F/Dose J Cohort 11 ext: AMG 701 Dose F/Dose J Cohort 12: AMG 701 Dose F/Dose L Cohort 12 ext: AMG 701 Dose F/Dose L Cohort 13: AMG 701 Dose F/Dose M Cohort 13 ext: AMG 701 Dose F/Dose M Cohort 14: AMG 701 Dose F/Dose N Cohort 14 ext: AMG 701 Dose F/Dose N Cohort 15: AMG 701 Dose F/Dose O eIV Cohort: AMG 701 Dose G/day (7-day eIV) + Dose N Cohort 14A: AMG 701 Dose F/Dose M/Dose N Cohort 15A: AMG 701 Dose F/Dose M/Dose O Cohort 15B Group 1: AMG 701 Dose F/Dose K/Dose O Cohort 15C Group 1: AMG 701 Dose F/Dose J/Dose M/Dose O Cohort 15C Group 2: AMG 701 Dose F/Dose J/Dose M/Dose O
    Number of subjects analysed
    0 [106]
    0 [107]
    0 [108]
    0 [109]
    0 [110]
    1
    0 [111]
    0 [112]
    0 [113]
    0 [114]
    2
    1
    1
    1
    2
    2
    0 [115]
    3
    2
    5
    2
    2
    2
    6
    19
    24
    5
    Units: months
        median (inter-quartile range (Q1-Q3))
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    1.0 (1.0 to 1.0)
    ( to )
    ( to )
    ( to )
    ( to )
    2.3 (1.8 to 2.8)
    1.0 (1.0 to 1.0)
    2.8 (2.8 to 2.8)
    1.9 (1.9 to 1.9)
    1.4 (1.0 to 1.9)
    1.0 (1.0 to 1.0)
    ( to )
    1.0 (1.0 to 1.9)
    1.9 (1.0 to 2.8)
    1.0 (1.0 to 1.1)
    1.4 (1.0 to 1.9)
    1.5 (1.0 to 2.0)
    1.0 (0.6 to 1.3)
    1.0 (0.9 to 1.0)
    1.0 (1.0 to 1.2)
    1.0 (1.0 to 1.0)
    1.0 (1.0 to 1.2)
    Notes
    [106] - No participants had a response of sCR, CR, VGPR or PR.
    [107] - No participants had a response of sCR, CR, VGPR or PR.
    [108] - No participants had a response of sCR, CR, VGPR or PR.
    [109] - No participants had a response of sCR, CR, VGPR or PR.
    [110] - No participants had a response of sCR, CR, VGPR or PR.
    [111] - No participants had a response of sCR, CR, VGPR or PR.
    [112] - No participants had a response of sCR, CR, VGPR or PR.
    [113] - No participants had a response of sCR, CR, VGPR or PR.
    [114] - No participants had a response of sCR, CR, VGPR or PR.
    [115] - No participants had a response of sCR, CR, VGPR or PR.
    No statistical analyses for this end point

    Secondary: Progression Free Survival (PFS) According to IMWG-UCR

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    End point title
    		 Progression Free Survival (PFS) According to IMWG-UCR
    End point description
    PFS was calculated as (date of confirmed PD or death or censoring - first dose date + 1) / 30.4375. PD: ≥ 25% increase in serum or urine M-protein, new bone lesions, ≥ 50% increase in circulating plasma cells. PFS data was censored: participants alive, no documented PD, no new anticancer therapy or procedure at time of analysis were censored at date of last study visit or the first dose date of any IP; participants alive, no documented PD, with new anticancer therapy or procedure were censored at last study visit prior to new treatment or first dose of any IP; participants with PD or death > 70 days after last study visit were censored at date of last visit prior to PD or death or first dose date of any IP. 95% CIs for medians and percentiles were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. 99999=value was not evaluable. Safety analysis set included all enrolled participants who received at least one dose of study treatment.
    End point type
    Secondary
    End point timeframe
    C1D1 to the earliest of: start of new multiple myeloma therapy, disease progression per IMWG-URC, death, or consent withdrawal; median time on study was 12.6 months.
    End point values
    		 Cohort 1: AMG 701 Dose A Cohort 2: AMG 701 Dose B Cohort 3: AMG 701 Dose C Cohort 4: AMG 701 Dose D Cohort 5: AMG 701 Dose E Cohort 6: AMG 701 Dose F Cohort 7: AMG 701 Dose H Cohort 8: AMG 701 Dose F/Dose G Cohort 9: AMG 701 Dose F/Dose H Cohort 9 extension (ext): AMG 701 Dose F/Dose H Cohort 10: AMG 701 Dose F/Dose I Cohort 10 ext: AMG 701 Dose F/Dose I Cohort 11: AMG 701 Dose F/Dose J Cohort 11 ext: AMG 701 Dose F/Dose J Cohort 12: AMG 701 Dose F/Dose L Cohort 12 ext: AMG 701 Dose F/Dose L Cohort 13: AMG 701 Dose F/Dose M Cohort 13 ext: AMG 701 Dose F/Dose M Cohort 14: AMG 701 Dose F/Dose N Cohort 14 ext: AMG 701 Dose F/Dose N Cohort 15: AMG 701 Dose F/Dose O eIV Cohort: AMG 701 Dose G/day (7-day eIV) + Dose N Cohort 14A: AMG 701 Dose F/Dose M/Dose N Cohort 15A: AMG 701 Dose F/Dose M/Dose O Cohort 15B Group 1: AMG 701 Dose F/Dose K/Dose O Cohort 15C Group 1: AMG 701 Dose F/Dose J/Dose M/Dose O Cohort 15C Group 2: AMG 701 Dose F/Dose J/Dose M/Dose O
    Number of subjects analysed
    1
    1
    1
    3
    4
    4
    1
    4
    5
    3
    8
    3
    4
    3
    5
    5
    4
    6
    5
    9
    4
    4
    4
    8
    32
    31
    10
    Units: months
        median (confidence interval 95%)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    3.5 (-99999 to 99999)
    1.0 (1.0 to 99999)
    1.0 (0.9 to 99999)
    1.0 (0.9 to 99999)
    0.6 (-99999 to 99999)
    2.8 (1.1 to 99999)
    1.6 (1.0 to 99999)
    1.9 (0.9 to 99999)
    2.8 (1.3 to 5.6)
    1.7 (1.1 to 99999)
    2.0 (0.3 to 99999)
    1.0 (0.9 to 99999)
    99999 (7.5 to 99999)
    37.5 (1.0 to 99999)
    1.0 (0.9 to 99999)
    19.0 (0.9 to 99999)
    1.9 (0.7 to 99999)
    26.3 (1.1 to 99999)
    4.6 (1.9 to 99999)
    5.5 (1.4 to 99999)
    22.9 (0.2 to 99999)
    6.5 (2.3 to 10.1)
    12.0 (2.8 to 99999)
    99999 (5.6 to 99999)
    11.1 (0.8 to 99999)
    No statistical analyses for this end point

    Secondary: Overall Survival (OS) According IMWG-UCR

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    End point title
    		 Overall Survival (OS) According IMWG-UCR
    End point description
    OS was calculated as (date of death or censoring - first dose date + 1) / 30.4375. Participants without event of death were censored at their last known alive date. 95% CIs for medians and percentiles were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. 99999 = value was not evaluable. Safety analysis set included all enrolled participants who received at least one dose of study treatment. Data is presented for participants who died.
    End point type
    Secondary
    End point timeframe
    C1D1 to 30 days after the last dose of investigational product or end of study; median time on study was 12.6 months
    End point values
    		 Cohort 1: AMG 701 Dose A Cohort 2: AMG 701 Dose B Cohort 3: AMG 701 Dose C Cohort 4: AMG 701 Dose D Cohort 5: AMG 701 Dose E Cohort 6: AMG 701 Dose F Cohort 7: AMG 701 Dose H Cohort 8: AMG 701 Dose F/Dose G Cohort 9: AMG 701 Dose F/Dose H Cohort 9 extension (ext): AMG 701 Dose F/Dose H Cohort 10: AMG 701 Dose F/Dose I Cohort 10 ext: AMG 701 Dose F/Dose I Cohort 11: AMG 701 Dose F/Dose J Cohort 11 ext: AMG 701 Dose F/Dose J Cohort 12: AMG 701 Dose F/Dose L Cohort 12 ext: AMG 701 Dose F/Dose L Cohort 13: AMG 701 Dose F/Dose M Cohort 13 ext: AMG 701 Dose F/Dose M Cohort 14: AMG 701 Dose F/Dose N Cohort 14 ext: AMG 701 Dose F/Dose N Cohort 15: AMG 701 Dose F/Dose O eIV Cohort: AMG 701 Dose G/day (7-day eIV) + Dose N Cohort 14A: AMG 701 Dose F/Dose M/Dose N Cohort 15A: AMG 701 Dose F/Dose M/Dose O Cohort 15B Group 1: AMG 701 Dose F/Dose K/Dose O Cohort 15C Group 1: AMG 701 Dose F/Dose J/Dose M/Dose O Cohort 15C Group 2: AMG 701 Dose F/Dose J/Dose M/Dose O
    Number of subjects analysed
    0 [116]
    1
    1
    3
    2
    2
    1
    4
    4
    2
    7
    1
    2
    2
    1
    2
    3
    6
    4
    4
    2
    3
    2
    7
    11
    8
    4
    Units: months
        median (confidence interval 95%)
    ( to )
    6.3 (-99999 to 99999)
    4.9 (-99999 to 99999)
    10.6 (7.9 to 99999)
    6.1 (2.8 to 99999)
    99999 (3.0 to 99999)
    0.6 (-99999 to 99999)
    12.4 (1.1 to 99999)
    13.9 (1.3 to 99999)
    18.1 (1.9 to 99999)
    14.6 (1.3 to 99999)
    99999 (5.6 to 99999)
    3.6 (2.2 to 99999)
    6.8 (0.9 to 99999)
    99999 (26.4 to 99999)
    99999 (2.8 to 99999)
    3.0 (1.5 to 99999)
    10.7 (4.1 to 99999)
    6.0 (0.7 to 99999)
    26.3 (3.8 to 99999)
    35.3 (3.9 to 99999)
    9.1 (1.4 to 99999)
    99999 (0.2 to 99999)
    12.9 (2.3 to 20.8)
    99999 (9.2 to 99999)
    99999 (16.8 to 99999)
    99999 (1.5 to 99999)
    Notes
    [116] - No participants in this treatment group died.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality was collected from first dose to end of study; median time on study was 12.6 months. Serious and other AEs were collected from first dose until last dose or end of study + 33 days; median duration on treatment was 4.1 months.
    Adverse event reporting additional description
    The safety analysis set included all enrolled participants who received at least one dose of AMG 701.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    Cohort 5: AMG 701 Dose E
    Reporting group description
    		 AMG 701 Dose E was administered as a weekly IV infusion in a 4-week cycle with no step dosing.

    Reporting group title
    Cohort 4: AMG 701 Dose D
    Reporting group description
    		 AMG 701 Dose D was administered as a weekly IV infusion in a 4-week cycle with no step dosing.

    Reporting group title
    Cohort 3: AMG 701 Dose C
    Reporting group description
    		 AMG 701 Dose C was administered as a weekly IV infusion in a 4-week cycle with no step dosing.

    Reporting group title
    Cohort 2: AMG 701 Dose B
    Reporting group description
    		 AMG 701 Dose B was administered as a weekly IV infusion in a 4-week cycle with no step dosing.

    Reporting group title
    Cohort 1: AMG 701 Dose A
    Reporting group description
    		 AMG 701 Dose A was administered as a weekly IV infusion in a 4-week cycle with no step dosing.

    Reporting group title
    Cohort 6: AMG 701 Dose F
    Reporting group description
    		 AMG 701 Dose F was administered as a weekly IV infusion in a 4-week cycle with no step dosing.

    Reporting group title
    Cohort 7: AMG 701 Dose H
    Reporting group description
    		 AMG 701 Dose H was administered as a weekly IV infusion in a 4-week cycle with no step dosing.

    Reporting group title
    Cohort 8: AMG 701 Dose F/Dose G
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose G weekly from C1D8 (4-week cycle).

    Reporting group title
    Cohort 11: AMG 701 Dose F/Dose J
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose J weekly from C1D8 (4-week cycle).

    Reporting group title
    Cohort 10 ext: AMG 701 Dose F/Dose I
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose I weekly from C1D5 (4-week cycle).

    Reporting group title
    Cohort 10: AMG 701 Dose F/Dose I
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose I weekly from C1D8 (4-week cycle).

    Reporting group title
    Cohort 9 extension (ext): AMG 701 Dose F/Dose H
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose H weekly from C1D5 (4-week cycle).

    Reporting group title
    Cohort 9: AMG 701 Dose F/Dose H
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose H weekly from C1D8 (4-week cycle).

    Reporting group title
    Cohort 11 ext: AMG 701 Dose F/Dose J
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose J weekly from C1D5 (4-week cycle).

    Reporting group title
    Cohort 12 ext: AMG 701 Dose F/Dose L
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose L weekly from C1D3 (4-week cycle).

    Reporting group title
    Cohort 12: AMG 701 Dose F/Dose L
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose L weekly from C1D8 (4-week cycle).

    Reporting group title
    Cohort 13: AMG 701 Dose F/Dose M
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose M weekly from C1D8 (4-week cycle).

    Reporting group title
    Cohort 13 ext: AMG 701 Dose F/Dose M
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose M weekly from C1D3 (4-week cycle).

    Reporting group title
    Cohort 14: AMG 701 Dose F/Dose N
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose N weekly from C1D8 (4-week cycle).

    Reporting group title
    Cohort 14 ext: AMG 701 Dose F/Dose N
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose N weekly from C1D3 (4-week cycle).

    Reporting group title
    Cohort 15: AMG 701 Dose F/Dose O
    Reporting group description
    		 AMG 701 was administered as an IV infusion with one-step dosing. Participants received AMG 701 Dose F on C1D1 and AMG 701 Dose O weekly from C1D8 (4-week cycle).

    Reporting group title
    eIV Cohort: AMG 701 Dose G/day (7-day eIV) + Dose N
    Reporting group description
    		 AMG 701 Dose G/day was administered as an eIV infusion over 7 days and participants received AMG 701 Dose N weekly from C1D8 (4-week cycle).

    Reporting group title
    Cohort 15A: AMG 701 Dose F/Dose M/Dose O
    Reporting group description
    		 AMG 701 was administered as an IV infusion with two-step dosing. Participants received AMG 701 Dose F on C1D1, AMG 701 Dose M on C1D3, and AMG 701 Dose O weekly from C1D8 (4-week cycle).

    Reporting group title
    Cohort 15B Group 1: AMG 701 Dose F/Dose K/Dose O
    Reporting group description
    		 AMG 701 was administered as an IV infusion with two-step dosing. Participants received AMG 701 Dose F on C1D1, AMG 701 Dose K on C1D3, and AMG 701 Dose O weekly from C1D8 (4-week cycle). Group 1 included participants who did not receive a prior BCMA targeting therapy.

    Reporting group title
    Cohort 15C Group 2: AMG 701 Dose F/Dose J/Dose M/Dose O
    Reporting group description
    		 AMG 701 was administered as an IV infusion with three-step dosing. Participants received AMG 701 Dose F on C1D1, AMG 701 Dose J on C1D3, AMG 701 Dose M on C1D5, and AMG 701 Dose O weekly from C1D8 (4-week cycle). Group 2 included participants who had relapsed or were intolerant to prior BCMA targeting therapy.

    Reporting group title
    Cohort 15C Group 1: AMG 701 Dose F/Dose J/Dose M/Dose O
    Reporting group description
    		 AMG 701 was administered as an IV infusion with three-step dosing. Participants received AMG 701 Dose F on C1D1, AMG 701 Dose J on C1D3, AMG 701 Dose M on C1D5, and AMG 701 Dose O weekly from C1D8 (4-week cycle). Group 1 included participants who did not receive a prior BCMA targeting therapy.

    Reporting group title
    Cohort 14A: AMG 701 Dose F/Dose M/Dose N
    Reporting group description
    		 AMG 701 was administered as an IV infusion with two-step dosing. Participants received AMG 701 Dose F on C1D1, AMG 701 Dose M on C1D3, and AMG 701 Dose N weekly from C1D8 (4-week cycle).

    Serious adverse events
    		 Cohort 5: AMG 701 Dose E Cohort 4: AMG 701 Dose D Cohort 3: AMG 701 Dose C Cohort 2: AMG 701 Dose B Cohort 1: AMG 701 Dose A Cohort 6: AMG 701 Dose F Cohort 7: AMG 701 Dose H Cohort 8: AMG 701 Dose F/Dose G Cohort 11: AMG 701 Dose F/Dose J Cohort 10 ext: AMG 701 Dose F/Dose I Cohort 10: AMG 701 Dose F/Dose I Cohort 9 extension (ext): AMG 701 Dose F/Dose H Cohort 9: AMG 701 Dose F/Dose H Cohort 11 ext: AMG 701 Dose F/Dose J Cohort 12 ext: AMG 701 Dose F/Dose L Cohort 12: AMG 701 Dose F/Dose L Cohort 13: AMG 701 Dose F/Dose M Cohort 13 ext: AMG 701 Dose F/Dose M Cohort 14: AMG 701 Dose F/Dose N Cohort 14 ext: AMG 701 Dose F/Dose N Cohort 15: AMG 701 Dose F/Dose O eIV Cohort: AMG 701 Dose G/day (7-day eIV) + Dose N Cohort 15A: AMG 701 Dose F/Dose M/Dose O Cohort 15B Group 1: AMG 701 Dose F/Dose K/Dose O Cohort 15C Group 2: AMG 701 Dose F/Dose J/Dose M/Dose O Cohort 15C Group 1: AMG 701 Dose F/Dose J/Dose M/Dose O Cohort 14A: AMG 701 Dose F/Dose M/Dose N
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 4 (25.00%)
    2 / 3 (66.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    2 / 4 (50.00%)
    1 / 1 (100.00%)
    2 / 4 (50.00%)
    2 / 4 (50.00%)
    1 / 3 (33.33%)
    4 / 8 (50.00%)
    1 / 3 (33.33%)
    2 / 5 (40.00%)
    2 / 3 (66.67%)
    3 / 5 (60.00%)
    2 / 5 (40.00%)
    3 / 4 (75.00%)
    5 / 6 (83.33%)
    4 / 5 (80.00%)
    7 / 9 (77.78%)
    1 / 4 (25.00%)
    3 / 4 (75.00%)
    5 / 8 (62.50%)
    23 / 32 (71.88%)
    7 / 10 (70.00%)
    21 / 31 (67.74%)
    3 / 4 (75.00%)
         number of deaths (all causes)
    2
    3
    1
    1
    0
    2
    1
    4
    2
    1
    7
    2
    4
    2
    2
    1
    3
    6
    4
    4
    2
    3
    7
    11
    4
    8
    2
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder transitional cell carcinoma stage II
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    1 / 5 (20.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    5 / 32 (15.63%)
    1 / 10 (10.00%)
    4 / 31 (12.90%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 5
    0 / 1
    0 / 4
    0 / 0
         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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 5
    0 / 1
    0 / 3
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Embolism
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Internal haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 1 (100.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oedema
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Performance status decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    3 / 32 (9.38%)
    1 / 10 (10.00%)
    2 / 31 (6.45%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    3 / 3
    0 / 1
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Cytokine release syndrome
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    1 / 1 (100.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    2 / 5 (40.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
    2 / 8 (25.00%)
    2 / 32 (6.25%)
    2 / 10 (20.00%)
    2 / 31 (6.45%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    2 / 2
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    3 / 3
    1 / 1
    2 / 2
    2 / 2
    2 / 2
    2 / 2
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    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 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    2 / 8 (25.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    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 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Brain herniation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (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 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fracture
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal cord injury
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (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 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related 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 / 0
    0 / 0
    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
    Cardiac failure chronic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus tachycardia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    Nervous system disorders
    Hydrocephalus
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    2 / 31 (6.45%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    4 / 10 (40.00%)
    1 / 31 (3.23%)
    0 / 4 (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 / 2
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    3 / 4
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    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 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Cataract
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (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
    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
    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 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (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 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (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
    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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    2 / 31 (6.45%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Segmental diverticular colitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sialocele
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Cholecystitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 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
    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 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Back pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis perforated
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    2 / 9 (22.22%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    3 / 32 (9.38%)
    0 / 10 (0.00%)
    2 / 31 (6.45%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    3 / 4
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    2 / 9 (22.22%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    3 / 32 (9.38%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (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
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    2 / 3
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    2 / 8 (25.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis klebsiella
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus chorioretinitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus oesophagitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus viraemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Disseminated mycobacterium avium complex infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis infectious
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    2 / 32 (6.25%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    1 / 4 (25.00%)
         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
    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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster disseminated
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    2 / 32 (6.25%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral discitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ludwig angina
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parainfluenzae virus infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (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
    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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumococcal sepsis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    2 / 9 (22.22%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    2 / 32 (6.25%)
    0 / 10 (0.00%)
    3 / 31 (9.68%)
    1 / 4 (25.00%)
         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 / 1
    0 / 0
    0 / 0
    0 / 0
    4 / 4
    0 / 0
    0 / 0
    0 / 0
    2 / 3
    0 / 0
    2 / 3
    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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia haemophilus
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 bacterial
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia klebsiella
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pseudomonal sepsis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    3 / 32 (9.38%)
    1 / 10 (10.00%)
    1 / 31 (3.23%)
    0 / 4 (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 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    2 / 3
    2 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinusitis fungal
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (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
    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
    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 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    1 / 4
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    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 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypophosphataemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    		 Cohort 5: AMG 701 Dose E Cohort 4: AMG 701 Dose D Cohort 3: AMG 701 Dose C Cohort 2: AMG 701 Dose B Cohort 1: AMG 701 Dose A Cohort 6: AMG 701 Dose F Cohort 7: AMG 701 Dose H Cohort 8: AMG 701 Dose F/Dose G Cohort 11: AMG 701 Dose F/Dose J Cohort 10 ext: AMG 701 Dose F/Dose I Cohort 10: AMG 701 Dose F/Dose I Cohort 9 extension (ext): AMG 701 Dose F/Dose H Cohort 9: AMG 701 Dose F/Dose H Cohort 11 ext: AMG 701 Dose F/Dose J Cohort 12 ext: AMG 701 Dose F/Dose L Cohort 12: AMG 701 Dose F/Dose L Cohort 13: AMG 701 Dose F/Dose M Cohort 13 ext: AMG 701 Dose F/Dose M Cohort 14: AMG 701 Dose F/Dose N Cohort 14 ext: AMG 701 Dose F/Dose N Cohort 15: AMG 701 Dose F/Dose O eIV Cohort: AMG 701 Dose G/day (7-day eIV) + Dose N Cohort 15A: AMG 701 Dose F/Dose M/Dose O Cohort 15B Group 1: AMG 701 Dose F/Dose K/Dose O Cohort 15C Group 2: AMG 701 Dose F/Dose J/Dose M/Dose O Cohort 15C Group 1: AMG 701 Dose F/Dose J/Dose M/Dose O Cohort 14A: AMG 701 Dose F/Dose M/Dose N
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 4 (100.00%)
    3 / 3 (100.00%)
    1 / 1 (100.00%)
    1 / 1 (100.00%)
    1 / 1 (100.00%)
    4 / 4 (100.00%)
    1 / 1 (100.00%)
    4 / 4 (100.00%)
    4 / 4 (100.00%)
    3 / 3 (100.00%)
    8 / 8 (100.00%)
    3 / 3 (100.00%)
    5 / 5 (100.00%)
    3 / 3 (100.00%)
    5 / 5 (100.00%)
    5 / 5 (100.00%)
    4 / 4 (100.00%)
    6 / 6 (100.00%)
    5 / 5 (100.00%)
    9 / 9 (100.00%)
    4 / 4 (100.00%)
    4 / 4 (100.00%)
    8 / 8 (100.00%)
    32 / 32 (100.00%)
    10 / 10 (100.00%)
    31 / 31 (100.00%)
    4 / 4 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Bowen's disease
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Malignant melanoma
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    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
    1
    0
    Malignant melanoma in situ
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Metastasis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Metastatic squamous cell carcinoma
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Ocular neoplasm
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Seborrhoeic keratosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Plasma cell myeloma
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    2 / 32 (6.25%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    0
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 1 (100.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    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 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Haematoma
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Hot flush
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    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
    0
    Hypertension
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    2 / 4 (50.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    1 / 10 (10.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    3
    1
    0
    1
    0
    0
    0
    2
    0
    2
    4
    0
    1
    0
    0
    0
    1
    1
    2
    0
    Hypotension
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    3 / 8 (37.50%)
    1 / 3 (33.33%)
    2 / 5 (40.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    2 / 4 (50.00%)
    1 / 6 (16.67%)
    1 / 5 (20.00%)
    2 / 9 (22.22%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    4 / 8 (50.00%)
    5 / 32 (15.63%)
    4 / 10 (40.00%)
    5 / 31 (16.13%)
    1 / 4 (25.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    3
    2
    5
    1
    0
    2
    3
    2
    1
    3
    0
    1
    4
    11
    11
    8
    1
    Orthostatic hypotension
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    2 / 31 (6.45%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    1
    0
    3
    0
    Phlebitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Surgical and medical procedures
    Tooth extraction
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Catheter site pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Chest pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    2 / 32 (6.25%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    1
    Chills
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    2 / 5 (40.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    2 / 9 (22.22%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    4 / 32 (12.50%)
    3 / 10 (30.00%)
    8 / 31 (25.81%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    2
    3
    0
    0
    1
    4
    1
    0
    0
    3
    1
    0
    0
    5
    3
    21
    0
    Disease progression
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    0
    0
    Generalised oedema
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Fatigue
         subjects affected / exposed
    1 / 4 (25.00%)
    2 / 3 (66.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    3 / 4 (75.00%)
    1 / 4 (25.00%)
    1 / 3 (33.33%)
    2 / 8 (25.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    4 / 5 (80.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    3 / 5 (60.00%)
    3 / 9 (33.33%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
    1 / 8 (12.50%)
    8 / 32 (25.00%)
    6 / 10 (60.00%)
    12 / 31 (38.71%)
    1 / 4 (25.00%)
         occurrences all number
    1
    3
    0
    0
    0
    3
    0
    3
    1
    1
    2
    2
    0
    0
    4
    3
    0
    1
    3
    4
    1
    1
    3
    15
    11
    17
    3
    Infusion site extravasation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Hernia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Hypothermia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Localised oedema
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    1
    0
    Mucosal inflammation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Malaise
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    1
    0
    1
    0
    0
    1
    0
    0
    0
    Oedema
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    1 / 32 (3.13%)
    3 / 10 (30.00%)
    4 / 31 (12.90%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    3
    1
    4
    5
    0
    Peripheral swelling
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    3 / 32 (9.38%)
    0 / 10 (0.00%)
    2 / 31 (6.45%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    2
    0
    0
    0
    0
    1
    0
    0
    5
    0
    2
    0
    Oedema peripheral
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    2 / 3 (66.67%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    2 / 6 (33.33%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
    1 / 8 (12.50%)
    3 / 32 (9.38%)
    2 / 10 (20.00%)
    3 / 31 (9.68%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    0
    0
    0
    0
    0
    0
    2
    0
    0
    1
    1
    1
    3
    2
    4
    0
    Pyrexia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
    2 / 3 (66.67%)
    3 / 8 (37.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    3 / 5 (60.00%)
    2 / 5 (40.00%)
    1 / 4 (25.00%)
    3 / 6 (50.00%)
    2 / 5 (40.00%)
    3 / 9 (33.33%)
    2 / 4 (50.00%)
    3 / 4 (75.00%)
    3 / 8 (37.50%)
    8 / 32 (25.00%)
    7 / 10 (70.00%)
    11 / 31 (35.48%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    1
    2
    3
    4
    0
    0
    1
    4
    3
    1
    15
    6
    8
    2
    3
    4
    16
    17
    25
    4
    Immune system disorders
    Cytokine release syndrome
         subjects affected / exposed
    3 / 4 (75.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    4 / 4 (100.00%)
    1 / 1 (100.00%)
    1 / 4 (25.00%)
    3 / 4 (75.00%)
    1 / 3 (33.33%)
    3 / 8 (37.50%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    2 / 3 (66.67%)
    4 / 5 (80.00%)
    4 / 5 (80.00%)
    4 / 4 (100.00%)
    6 / 6 (100.00%)
    5 / 5 (100.00%)
    8 / 9 (88.89%)
    4 / 4 (100.00%)
    4 / 4 (100.00%)
    7 / 8 (87.50%)
    25 / 32 (78.13%)
    8 / 10 (80.00%)
    23 / 31 (74.19%)
    4 / 4 (100.00%)
         occurrences all number
    5
    0
    0
    0
    0
    6
    1
    1
    12
    2
    6
    1
    2
    7
    6
    10
    8
    16
    15
    21
    13
    12
    15
    45
    11
    43
    16
    Drug hypersensitivity
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Hypersensitivity
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Hypogammaglobulinaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    4 / 31 (12.90%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    1
    0
    8
    0
    Reproductive system and breast disorders
    Pelvic pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    2 / 31 (6.45%)
    0 / 4 (0.00%)
         occurrences all number
    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
    4
    0
    Prostatomegaly
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Vaginal discharge
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    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
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Vulvovaginal erythema
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Atelectasis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    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
    Dysphonia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Cough
         subjects affected / exposed
    1 / 4 (25.00%)
    2 / 3 (66.67%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    4 / 8 (50.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    2 / 5 (40.00%)
    3 / 9 (33.33%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    2 / 8 (25.00%)
    9 / 32 (28.13%)
    5 / 10 (50.00%)
    11 / 31 (35.48%)
    2 / 4 (50.00%)
         occurrences all number
    2
    2
    0
    0
    0
    0
    0
    0
    0
    0
    5
    2
    0
    0
    1
    8
    0
    1
    2
    4
    0
    1
    2
    16
    6
    27
    5
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Dyspnoea
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    2 / 4 (50.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    2 / 8 (25.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    2 / 5 (40.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    3 / 32 (9.38%)
    1 / 10 (10.00%)
    4 / 31 (12.90%)
    0 / 4 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    0
    2
    0
    0
    2
    0
    1
    0
    0
    0
    1
    0
    2
    1
    0
    0
    0
    5
    2
    5
    0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    2 / 10 (20.00%)
    6 / 31 (19.35%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    2
    8
    0
    Epistaxis
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    2 / 32 (6.25%)
    0 / 10 (0.00%)
    2 / 31 (6.45%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    3
    0
    Hypoxia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    2 / 31 (6.45%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    1
    5
    0
    Laryngeal inflammation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nasal congestion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    2 / 32 (6.25%)
    0 / 10 (0.00%)
    6 / 31 (19.35%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    1
    2
    0
    7
    0
    Organising pneumonia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nasal dryness
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    2 / 5 (40.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Oropharyngeal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    2 / 6 (33.33%)
    1 / 5 (20.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    1 / 10 (10.00%)
    4 / 31 (12.90%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    2
    0
    0
    0
    1
    1
    6
    0
    Pleural effusion
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    2 / 32 (6.25%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    2
    0
    1
    0
    Paranasal sinus discomfort
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Pneumonitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Pneumothorax
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Productive cough
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    2 / 32 (6.25%)
    1 / 10 (10.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    2
    1
    1
    0
    Pulmonary oedema
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Pulmonary hypertension
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Reflux laryngitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Respiratory failure
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 1 (100.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    2 / 32 (6.25%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Rhinorrhoea
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    2 / 9 (22.22%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    1 / 10 (10.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    2
    0
    0
    0
    1
    1
    1
    0
    Sinus congestion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    3
    0
    0
    0
    Sinus pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    2 / 32 (6.25%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    Upper-airway cough syndrome
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    Stridor
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Wheezing
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    3
    0
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Confusional state
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    1
    0
    1
    1
    0
    0
    1
    1
    0
    0
    0
    Anxiety
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    2 / 10 (20.00%)
    2 / 31 (6.45%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    2
    3
    0
    Delirium
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Depressed mood
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Delirium febrile
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Depression
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Insomnia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    2 / 5 (40.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    4 / 32 (12.50%)
    2 / 10 (20.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    2
    0
    1
    1
    0
    1
    1
    1
    1
    3
    0
    0
    1
    0
    0
    0
    1
    0
    4
    4
    2
    0
    Mental status changes
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Product issues
    Device loosening
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 3 (33.33%)
    2 / 5 (40.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    2 / 4 (50.00%)
    2 / 6 (33.33%)
    0 / 5 (0.00%)
    2 / 9 (22.22%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    6 / 32 (18.75%)
    3 / 10 (30.00%)
    5 / 31 (16.13%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    1
    0
    2
    1
    4
    0
    1
    10
    4
    3
    0
    3
    0
    4
    0
    12
    7
    7
    0
    Amylase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    2 / 5 (40.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    3 / 32 (9.38%)
    0 / 10 (0.00%)
    5 / 31 (16.13%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    20
    0
    2
    0
    1
    0
    0
    1
    5
    0
    50
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 1 (100.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    2 / 8 (25.00%)
    2 / 32 (6.25%)
    3 / 10 (30.00%)
    6 / 31 (19.35%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    2
    0
    0
    0
    0
    12
    0
    1
    0
    0
    0
    1
    2
    3
    7
    9
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    1 / 3 (33.33%)
    2 / 5 (40.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    2 / 4 (50.00%)
    2 / 6 (33.33%)
    0 / 5 (0.00%)
    2 / 9 (22.22%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    6 / 32 (18.75%)
    2 / 10 (20.00%)
    6 / 31 (19.35%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    0
    0
    0
    1
    3
    1
    3
    0
    0
    12
    5
    6
    0
    4
    0
    3
    0
    13
    8
    7
    0
    Blood bicarbonate decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Blood creatine increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    1
    0
    0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    2
    0
    1
    0
    Blood creatinine increased
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 1 (100.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    2 / 32 (6.25%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    4
    0
    0
    0
    0
    3
    4
    1
    0
    0
    Blood phosphorus decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    2 / 31 (6.45%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    5
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    2 / 32 (6.25%)
    0 / 10 (0.00%)
    5 / 31 (16.13%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    11
    0
    6
    0
    Blood fibrinogen decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    1
    0
    Blood potassium decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    2 / 31 (6.45%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    C-reactive protein increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    1 / 3 (33.33%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    4 / 32 (12.50%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    7
    0
    1
    0
    Bordetella test positive
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood uric acid increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    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
    2
    0
    Chest X-ray abnormal
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    3
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Cytomegalovirus test positive
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Clostridium test positive
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Electrocardiogram ST segment elevation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Fibrin D dimer increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    2 / 32 (6.25%)
    0 / 10 (0.00%)
    2 / 31 (6.45%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    2
    0
    0
    0
    0
    9
    0
    0
    0
    0
    0
    0
    0
    5
    0
    4
    0
    Glucose urine
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Heart rate increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Human rhinovirus test positive
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Influenza A virus test positive
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Lipase
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    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
    Lipase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    3 / 5 (60.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    2 / 32 (6.25%)
    1 / 10 (10.00%)
    7 / 31 (22.58%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    6
    0
    0
    1
    0
    50
    0
    1
    0
    1
    0
    0
    0
    2
    9
    23
    0
    International normalised ratio increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Investigation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Liver function test abnormal
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    2 / 9 (22.22%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    2 / 8 (25.00%)
    8 / 32 (25.00%)
    6 / 10 (60.00%)
    12 / 31 (38.71%)
    2 / 4 (50.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    5
    0
    16
    0
    0
    11
    44
    48
    53
    10
    Neutrophil count
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Neutrophil count decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    2 / 9 (22.22%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    3 / 8 (37.50%)
    9 / 32 (28.13%)
    2 / 10 (20.00%)
    6 / 31 (19.35%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    2
    1
    3
    1
    0
    0
    1
    0
    0
    1
    0
    4
    0
    1
    13
    20
    8
    12
    4
    Platelet count decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 1 (100.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    1 / 8 (12.50%)
    10 / 32 (31.25%)
    2 / 10 (20.00%)
    5 / 31 (16.13%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    4
    0
    0
    1
    0
    0
    0
    5
    0
    2
    0
    0
    0
    0
    0
    1
    1
    20
    13
    9
    8
    SARS-CoV-2 test positive
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    2 / 32 (6.25%)
    0 / 10 (0.00%)
    2 / 31 (6.45%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    3
    0
    Serum ferritin increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    3 / 32 (9.38%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Urinary occult blood positive
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Weight decreased
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    2
    0
    2
    1
    0
    0
    0
    0
    1
    0
    2
    0
    Weight increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    White blood cell count decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    5 / 32 (15.63%)
    6 / 10 (60.00%)
    8 / 31 (25.81%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    5
    25
    20
    22
    6
    Urine output decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    2 / 32 (6.25%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    2
    0
    0
    2
    0
    0
    0
    0
    2
    0
    0
    0
    Fall
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    Foot fracture
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hand fracture
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Humerus fracture
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Incorrect drug administration rate
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Incorrect product administration duration
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    2 / 5 (40.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    9
    0
    7
    28
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Infusion related reaction
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    2 / 5 (40.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    2 / 9 (22.22%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    2 / 32 (6.25%)
    0 / 10 (0.00%)
    4 / 31 (12.90%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    2
    2
    0
    2
    4
    0
    6
    0
    Ligament sprain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Joint dislocation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Muscle strain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Rib fracture
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    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 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Skin laceration
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    1
    0
    0
    0
    Subdural haematoma
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Stress fracture
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Spinal compression fracture
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    3
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Sunburn
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Urinary tract injury
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Transfusion reaction
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Tooth fracture
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    2 / 9 (22.22%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    2
    0
    0
    2
    1
    0
    0
    0
    Atrial flutter
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Bradycardia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    2 / 31 (6.45%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    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
    Cardiac arrest
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Cardiac failure congestive
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Cardiomyopathy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Palpitations
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    2
    0
    Nodal rhythm
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Right ventricular dysfunction
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 1 (100.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Sinus tachycardia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    2 / 8 (25.00%)
    3 / 32 (9.38%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    4
    2
    0
    0
    Sinus bradycardia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Tachyarrhythmia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Tachycardia
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    2 / 4 (50.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    2 / 10 (20.00%)
    4 / 31 (12.90%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    3
    1
    0
    0
    0
    0
    1
    0
    0
    1
    3
    0
    0
    0
    0
    0
    5
    6
    5
    0
    Nervous system disorders
    Burning sensation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Cauda equina syndrome
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Cognitive disorder
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dysaesthesia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dizziness
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    2 / 8 (25.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    4 / 32 (12.50%)
    2 / 10 (20.00%)
    3 / 31 (9.68%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    5
    2
    3
    0
    Dysgeusia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    4
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Encephalopathy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Facial nerve disorder
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Facial paresis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Headache
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    3 / 4 (75.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    2 / 5 (40.00%)
    1 / 3 (33.33%)
    3 / 5 (60.00%)
    2 / 5 (40.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    3 / 5 (60.00%)
    2 / 9 (22.22%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    2 / 8 (25.00%)
    13 / 32 (40.63%)
    6 / 10 (60.00%)
    12 / 31 (38.71%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    3
    1
    0
    9
    0
    2
    1
    9
    4
    0
    0
    5
    6
    0
    0
    3
    20
    13
    24
    0
    Hypoaesthesia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    2
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Memory impairment
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Lethargy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Muscle spasticity
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nervous system disorder
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neuralgia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Neuropathy peripheral
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    2 / 5 (40.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    2 / 32 (6.25%)
    1 / 10 (10.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    2
    2
    0
    0
    0
    0
    0
    0
    1
    2
    1
    1
    0
    Neurotoxicity
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Paraesthesia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    2 / 5 (40.00%)
    1 / 5 (20.00%)
    2 / 4 (50.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    3
    1
    2
    0
    1
    0
    0
    1
    0
    1
    0
    0
    0
    Presyncope
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    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
    0
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    3 / 8 (37.50%)
    1 / 32 (3.13%)
    1 / 10 (10.00%)
    2 / 31 (6.45%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    4
    2
    1
    3
    0
    Restless legs syndrome
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Syncope
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Taste disorder
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Tremor
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 4 (75.00%)
    3 / 3 (100.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 1 (100.00%)
    2 / 4 (50.00%)
    2 / 4 (50.00%)
    2 / 3 (66.67%)
    6 / 8 (75.00%)
    2 / 3 (66.67%)
    4 / 5 (80.00%)
    1 / 3 (33.33%)
    3 / 5 (60.00%)
    5 / 5 (100.00%)
    2 / 4 (50.00%)
    4 / 6 (66.67%)
    2 / 5 (40.00%)
    6 / 9 (66.67%)
    3 / 4 (75.00%)
    2 / 4 (50.00%)
    4 / 8 (50.00%)
    19 / 32 (59.38%)
    7 / 10 (70.00%)
    20 / 31 (64.52%)
    1 / 4 (25.00%)
         occurrences all number
    12
    5
    0
    4
    0
    0
    5
    5
    5
    2
    17
    18
    25
    3
    6
    9
    5
    4
    6
    31
    4
    4
    5
    44
    34
    56
    11
    Coagulopathy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Coombs negative haemolytic anaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Disseminated intravascular coagulation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Febrile neutropenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    2 / 10 (20.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    1
    0
    0
    0
    1
    3
    0
    1
    2
    1
    0
    Hyperviscosity syndrome
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Hypofibrinogenaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Lymphopenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    2 / 4 (50.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    2 / 5 (40.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    2 / 32 (6.25%)
    0 / 10 (0.00%)
    2 / 31 (6.45%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    5
    0
    1
    0
    0
    0
    0
    2
    0
    0
    1
    0
    0
    0
    0
    14
    0
    14
    0
    Leukopenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    2 / 4 (50.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    2 / 32 (6.25%)
    0 / 10 (0.00%)
    2 / 31 (6.45%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    6
    0
    0
    0
    0
    0
    0
    1
    0
    4
    1
    0
    1
    0
    0
    16
    0
    3
    0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Monocytopenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Monocytosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Neutropenia
         subjects affected / exposed
    1 / 4 (25.00%)
    2 / 3 (66.67%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    3 / 4 (75.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    3 / 5 (60.00%)
    0 / 4 (0.00%)
    2 / 6 (33.33%)
    3 / 5 (60.00%)
    6 / 9 (66.67%)
    2 / 4 (50.00%)
    0 / 4 (0.00%)
    2 / 8 (25.00%)
    10 / 32 (31.25%)
    4 / 10 (40.00%)
    11 / 31 (35.48%)
    3 / 4 (75.00%)
         occurrences all number
    3
    4
    2
    0
    0
    7
    0
    0
    7
    0
    3
    8
    4
    4
    2
    16
    0
    3
    17
    31
    7
    0
    4
    63
    27
    20
    7
    Thrombocytopenia
         subjects affected / exposed
    3 / 4 (75.00%)
    1 / 3 (33.33%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    3 / 5 (60.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    3 / 9 (33.33%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    6 / 32 (18.75%)
    4 / 10 (40.00%)
    11 / 31 (35.48%)
    0 / 4 (0.00%)
         occurrences all number
    12
    7
    2
    0
    1
    2
    0
    1
    0
    0
    1
    11
    8
    1
    0
    16
    1
    0
    2
    9
    1
    0
    1
    25
    11
    29
    0
    Thrombocytopenic purpura
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Ear and labyrinth disorders
    Ear disorder
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Ear pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    2 / 32 (6.25%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    Hypoacusis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Eye disorders
    Blindness unilateral
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Cataract
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    2 / 32 (6.25%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    1
    0
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Dry eye
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    1
    0
    0
    0
    0
    0
    1
    1
    0
    0
    Epiretinal membrane
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Eye pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    2 / 32 (6.25%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    1
    0
    Episcleritis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Eye pruritus
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Eyelid ptosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Lacrimation increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Optic neuropathy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Periorbital oedema
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Retinopathy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Vision blurred
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    2 / 32 (6.25%)
    2 / 10 (20.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    1
    1
    0
    2
    2
    1
    0
    Visual impairment
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    3 / 32 (9.38%)
    1 / 10 (10.00%)
    2 / 31 (6.45%)
    1 / 4 (25.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    1
    0
    2
    1
    0
    0
    0
    1
    0
    0
    0
    4
    1
    2
    1
    Abdominal distension
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    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
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    3
    0
    1
    0
    Colitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Ascites
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    0
    0
    Constipation
         subjects affected / exposed
    3 / 4 (75.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    3 / 3 (100.00%)
    2 / 5 (40.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    1 / 4 (25.00%)
    1 / 6 (16.67%)
    1 / 5 (20.00%)
    2 / 9 (22.22%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    5 / 32 (15.63%)
    4 / 10 (40.00%)
    4 / 31 (12.90%)
    0 / 4 (0.00%)
         occurrences all number
    4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    3
    2
    0
    0
    1
    1
    2
    3
    2
    0
    0
    0
    7
    5
    6
    0
    Dry mouth
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 3 (33.33%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    3 / 4 (75.00%)
    1 / 4 (25.00%)
    1 / 3 (33.33%)
    3 / 8 (37.50%)
    3 / 3 (100.00%)
    1 / 5 (20.00%)
    2 / 3 (66.67%)
    1 / 5 (20.00%)
    2 / 5 (40.00%)
    1 / 4 (25.00%)
    2 / 6 (33.33%)
    2 / 5 (40.00%)
    2 / 9 (22.22%)
    2 / 4 (50.00%)
    2 / 4 (50.00%)
    4 / 8 (50.00%)
    12 / 32 (37.50%)
    6 / 10 (60.00%)
    7 / 31 (22.58%)
    2 / 4 (50.00%)
         occurrences all number
    1
    1
    1
    0
    0
    5
    0
    4
    1
    1
    5
    4
    1
    2
    1
    6
    2
    4
    3
    6
    4
    4
    7
    32
    12
    12
    4
    Dental caries
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Duodenitis haemorrhagic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Dyspepsia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    1 / 32 (3.13%)
    2 / 10 (20.00%)
    1 / 31 (3.23%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    4
    2
    1
    1
    Dysphagia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Flatulence
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    2 / 10 (20.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    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
    1
    0
    Gastritis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Gastrointestinal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    1 / 8 (12.50%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    2 / 31 (6.45%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    3
    0
    Gingival disorder
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Haemorrhoids
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    Nausea
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    1 / 3 (33.33%)
    2 / 5 (40.00%)
    1 / 3 (33.33%)
    3 / 5 (60.00%)
    3 / 5 (60.00%)
    1 / 4 (25.00%)
    2 / 6 (33.33%)
    3 / 5 (60.00%)
    2 / 9 (22.22%)
    1 / 4 (25.00%)
    3 / 4 (75.00%)
    2 / 8 (25.00%)
    11 / 32 (34.38%)
    7 / 10 (70.00%)
    10 / 31 (32.26%)
    2 / 4 (50.00%)
         occurrences all number
    3
    1
    0
    0
    0
    0
    0
    1
    0
    1
    1
    1
    2
    2
    3
    7
    1
    2
    4
    3
    1
    4
    3
    21
    10
    20
    2
    Ileus
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 1 (100.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hypoaesthesia oral
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Paraesthesia oral
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Oral dysaesthesia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Oral disorder
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Proctalgia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Sialocele
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Toothache
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    2 / 10 (20.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    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
    0
    Stomatitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    3 / 32 (9.38%)
    0 / 10 (0.00%)
    2 / 31 (6.45%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    3
    0
    2
    0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Vomiting
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    1 / 9 (11.11%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
    1 / 8 (12.50%)
    7 / 32 (21.88%)
    4 / 10 (40.00%)
    4 / 31 (12.90%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    1
    0
    0
    0
    2
    1
    0
    1
    1
    1
    1
    2
    10
    5
    4
    1
    Hepatobiliary disorders
    Hepatic fibrosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Hepatic steatosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hypertransaminasaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    2
    0
    0
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Actinic keratosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Alopecia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    Drug eruption
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Dry skin
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    Eczema
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    1
    0
    Erythema multiforme
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Erythema
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    Haemorrhage subcutaneous
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neurodermatitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Night sweats
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    2 / 5 (40.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    2
    0
    0
    0
    0
    1
    1
    0
    0
    Pain of skin
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    2 / 32 (6.25%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Petechiae
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    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
    1
    0
    Purpura
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Pruritus
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    1 / 8 (12.50%)
    3 / 32 (9.38%)
    3 / 10 (30.00%)
    4 / 31 (12.90%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    1
    2
    21
    6
    4
    0
    Rash
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    2 / 5 (40.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    3 / 32 (9.38%)
    1 / 10 (10.00%)
    3 / 31 (9.68%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    3
    0
    0
    0
    1
    4
    2
    3
    1
    Rash maculo-papular
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    5 / 32 (15.63%)
    1 / 10 (10.00%)
    3 / 31 (9.68%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    2
    3
    0
    8
    1
    4
    1
    Rash erythematous
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    2 / 32 (6.25%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Rash morbilliform
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Rash pruritic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    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
    0
    Skin disorder
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Skin lesion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    2
    0
    0
    0
    Skin exfoliation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Skin sensitisation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Skin mass
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Urticaria
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    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
    3
    Renal and urinary disorders
    Azotaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Acute kidney injury
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    1 / 1 (100.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    2 / 6 (33.33%)
    1 / 5 (20.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    3
    1
    1
    0
    0
    0
    0
    5
    0
    0
    Chronic kidney disease
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Dysuria
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Haematuria
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    1
    0
    0
    0
    2
    0
    Micturition disorder
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nephrolithiasis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Renal cyst
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Urinary incontinence
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    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
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    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
    Urinary retention
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Urine flow decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 8 (0.00%)
    2 / 3 (66.67%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    3 / 5 (60.00%)
    2 / 9 (22.22%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    8 / 32 (25.00%)
    2 / 10 (20.00%)
    5 / 31 (16.13%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    2
    2
    0
    2
    4
    0
    0
    7
    2
    2
    1
    0
    9
    2
    9
    1
    Back pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    1 / 5 (20.00%)
    2 / 9 (22.22%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    4 / 32 (12.50%)
    2 / 10 (20.00%)
    4 / 31 (12.90%)
    1 / 4 (25.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    1
    0
    1
    1
    0
    1
    0
    1
    1
    0
    1
    2
    3
    0
    0
    1
    4
    4
    7
    1
    Bone pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    2 / 32 (6.25%)
    0 / 10 (0.00%)
    2 / 31 (6.45%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    8
    0
    2
    0
    Bursitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    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
    Flank pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    3 / 32 (9.38%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    Greater trochanteric pain syndrome
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Joint effusion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Groin pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    Joint stiffness
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    0
    Muscle spasms
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Joint swelling
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Muscular weakness
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    1
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    2 / 32 (6.25%)
    2 / 10 (20.00%)
    2 / 31 (6.45%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    2
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    2
    3
    5
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Neck mass
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Myalgia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    1 / 10 (10.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    1
    1
    1
    0
    Neck pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neuropathic muscular atrophy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Osteonecrosis of jaw
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Pain in extremity
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    2 / 5 (40.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    1 / 10 (10.00%)
    4 / 31 (12.90%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    0
    1
    1
    1
    0
    0
    0
    4
    0
    1
    1
    0
    0
    1
    0
    1
    2
    11
    1
    Pain in jaw
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Spinal instability
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Sacral pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    2 / 5 (40.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Spinal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Synovitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    1
    Tenosynovitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    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
    Infections and infestations
    Bacteraemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    2 / 6 (33.33%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Asymptomatic bacteriuria
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Abscess jaw
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Bacterial disease carrier
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Bacteriuria
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Bronchitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    2
    0
    COVID-19
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    2 / 5 (40.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    3 / 9 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    5 / 32 (15.63%)
    1 / 10 (10.00%)
    6 / 31 (19.35%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    2
    0
    1
    0
    3
    0
    0
    3
    5
    1
    6
    1
    Candida infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Cellulitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    2 / 32 (6.25%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    1
    0
    0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Cytomegalovirus infection reactivation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    2
    0
    0
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    1
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    0
    Cytomegalovirus oesophagitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Diarrhoea infectious
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Eye infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Escherichia sepsis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Erysipelas
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Fungal skin infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Gastroenteritis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    2 / 31 (6.45%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Gingivitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    1
    0
    Haemophilus infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Influenza
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Labyrinthitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Lower respiratory tract infection viral
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Oesophageal candidiasis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Nasopharyngitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    2 / 32 (6.25%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    1
    1
    Onychomycosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Oral candidiasis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 4 (25.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    2
    0
    0
    0
    0
    2
    0
    Otitis externa
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Parainfluenzae virus infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Otitis media
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Parvovirus B19 infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Pharyngitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Pneumonia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    1 / 1 (100.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    1 / 10 (10.00%)
    1 / 31 (3.23%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    1
    0
    1
    0
    1
    0
    0
    2
    0
    1
    0
    0
    0
    1
    2
    1
    1
    Pneumonia aspiration
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Polyomavirus viraemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Prostatic abscess
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Pulpitis dental
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pseudomonas infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Respiratory tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    2 / 5 (40.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pyuria
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Rhinitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Salmonellosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Sepsis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Septic shock
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Rhinovirus infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    1 / 8 (12.50%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    6 / 31 (19.35%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    1
    0
    1
    1
    1
    0
    8
    1
    Sputum purulent
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    4 / 32 (12.50%)
    3 / 10 (30.00%)
    4 / 31 (12.90%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    1
    0
    0
    1
    0
    1
    0
    0
    0
    5
    4
    6
    1
    Sinobronchitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Tooth infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    2 / 4 (50.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    2
    0
    0
    0
    0
    0
    Staphylococcal infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    0
    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
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
    1 / 8 (12.50%)
    6 / 32 (18.75%)
    0 / 10 (0.00%)
    8 / 31 (25.81%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    0
    0
    0
    4
    0
    0
    2
    0
    0
    0
    0
    0
    1
    1
    1
    0
    1
    0
    1
    1
    1
    8
    0
    8
    1
    Upper respiratory tract infection bacterial
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    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
    Urinary tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    3 / 4 (75.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    2 / 5 (40.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    2 / 4 (50.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    3 / 32 (9.38%)
    1 / 10 (10.00%)
    3 / 31 (9.68%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    5
    0
    0
    0
    0
    0
    1
    2
    1
    0
    1
    0
    1
    2
    0
    1
    8
    1
    4
    1
    Urinary tract infection bacterial
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Urinary tract infection enterococcal
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Vaginal infection
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Viral infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Decreased appetite
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    2 / 8 (25.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    2 / 6 (33.33%)
    1 / 5 (20.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    4 / 32 (12.50%)
    6 / 10 (60.00%)
    5 / 31 (16.13%)
    0 / 4 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    1
    0
    3
    0
    0
    1
    0
    1
    0
    2
    2
    1
    0
    0
    0
    5
    10
    7
    0
    Dehydration
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    2 / 10 (20.00%)
    2 / 31 (6.45%)
    0 / 4 (0.00%)
         occurrences all number
    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
    2
    0
    Hyperammonaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Hypercalcaemia
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    2 / 8 (25.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    1 / 4 (25.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    1 / 32 (3.13%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    3
    2
    0
    0
    1
    0
    0
    1
    0
    0
    4
    3
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    Hyperchloraemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Hyperglycaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 1 (100.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    2 / 8 (25.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    3 / 6 (50.00%)
    0 / 5 (0.00%)
    2 / 9 (22.22%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    4 / 32 (12.50%)
    3 / 10 (30.00%)
    7 / 31 (22.58%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    6
    0
    0
    0
    8
    0
    0
    0
    1
    0
    0
    7
    0
    2
    0
    0
    1
    8
    3
    10
    2
    Hyperkalaemia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 1 (100.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    2 / 8 (25.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    1 / 8 (12.50%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    0
    3
    0
    2
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    2
    3
    0
    1
    0
    0
    Hyperphosphataemia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    4 / 32 (12.50%)
    0 / 10 (0.00%)
    2 / 31 (6.45%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    5
    0
    3
    0
    Hypernatraemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Hypermagnesaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 1 (100.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    2 / 32 (6.25%)
    1 / 10 (10.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    1
    3
    3
    1
    0
    Hyperuricaemia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    1 / 4 (25.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    3 / 9 (33.33%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 8 (0.00%)
    2 / 32 (6.25%)
    2 / 10 (20.00%)
    3 / 31 (9.68%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    1
    2
    0
    1
    1
    2
    0
    5
    0
    1
    0
    2
    2
    3
    0
    Hypervolaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    2 / 32 (6.25%)
    2 / 10 (20.00%)
    7 / 31 (22.58%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    1
    0
    2
    0
    0
    0
    2
    7
    10
    0
    Hypocalcaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    2 / 5 (40.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    2 / 8 (25.00%)
    6 / 32 (18.75%)
    4 / 10 (40.00%)
    9 / 31 (29.03%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    2
    0
    1
    0
    3
    0
    0
    3
    10
    9
    27
    0
    Hypoglycaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    1 / 10 (10.00%)
    2 / 31 (6.45%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    4
    4
    0
    Hypokalaemia
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 4 (25.00%)
    0 / 1 (0.00%)
    3 / 4 (75.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    2 / 3 (66.67%)
    1 / 5 (20.00%)
    2 / 3 (66.67%)
    1 / 5 (20.00%)
    2 / 5 (40.00%)
    1 / 4 (25.00%)
    2 / 6 (33.33%)
    1 / 5 (20.00%)
    5 / 9 (55.56%)
    2 / 4 (50.00%)
    0 / 4 (0.00%)
    2 / 8 (25.00%)
    10 / 32 (31.25%)
    6 / 10 (60.00%)
    10 / 31 (32.26%)
    3 / 4 (75.00%)
         occurrences all number
    2
    1
    0
    0
    0
    1
    0
    4
    0
    0
    1
    11
    8
    5
    2
    2
    3
    5
    1
    11
    3
    0
    3
    18
    9
    30
    6
    Hypomagnesaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    1 / 4 (25.00%)
    1 / 1 (100.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    1 / 3 (33.33%)
    2 / 5 (40.00%)
    1 / 3 (33.33%)
    1 / 5 (20.00%)
    3 / 5 (60.00%)
    2 / 4 (50.00%)
    4 / 6 (66.67%)
    1 / 5 (20.00%)
    4 / 9 (44.44%)
    2 / 4 (50.00%)
    1 / 4 (25.00%)
    2 / 8 (25.00%)
    7 / 32 (21.88%)
    5 / 10 (50.00%)
    8 / 31 (25.81%)
    3 / 4 (75.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    1
    0
    0
    0
    0
    2
    2
    1
    1
    5
    5
    8
    1
    9
    5
    1
    2
    10
    15
    15
    5
    Hypophagia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Hyponatraemia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    1 / 5 (20.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 8 (12.50%)
    3 / 32 (9.38%)
    2 / 10 (20.00%)
    4 / 31 (12.90%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    4
    1
    0
    0
    0
    1
    1
    1
    0
    0
    1
    3
    5
    11
    3
    Hypophosphataemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    1 / 1 (100.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    3 / 8 (37.50%)
    2 / 3 (66.67%)
    3 / 5 (60.00%)
    1 / 3 (33.33%)
    2 / 5 (40.00%)
    3 / 5 (60.00%)
    1 / 4 (25.00%)
    2 / 6 (33.33%)
    3 / 5 (60.00%)
    5 / 9 (55.56%)
    4 / 4 (100.00%)
    1 / 4 (25.00%)
    4 / 8 (50.00%)
    13 / 32 (40.63%)
    6 / 10 (60.00%)
    19 / 31 (61.29%)
    4 / 4 (100.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    0
    0
    2
    3
    14
    7
    1
    4
    9
    2
    3
    8
    18
    8
    1
    5
    31
    17
    70
    9
    Iron deficiency
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 9 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    2 / 32 (6.25%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    1
    0
    1
    0
    0
    2
    0
    1
    0
    Hypovolaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 9 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Iron overload
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Metabolic acidosis
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    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
    Malnutrition
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 3 (33.33%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Lactic acidosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    0 / 31 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    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
    Tumour lysis syndrome
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 4 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 8 (0.00%)
    0 / 32 (0.00%)
    0 / 10 (0.00%)
    1 / 31 (3.23%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Aug 2017
    - Tapering of steroid pre-treatment between subsequent infusions in the same treatment cycle was removed; the required steroid dose for cycles 3 and 4 was increased. - Inclusion criteria revised to specify that participants must not be candidates for regimens known to provide clinical benefit (proteasome inhibitors, immunomodulatory drugs, and, where approved and available, CD38-directed cytolytic antibodies) to be eligible for the study. - The DLT definition was revised in line with Food and Drug Administration (FDA) requests. - The requirements for access to a medical intensive care unit during participant hospitalization periods and the requirement for sites to have cytokine release syndrome (CRS) rescue medications available on site (including at least two doses of tocilizumab per participant for US sites) were added. - The Schedule of Assessment footnotes were revised to include a reference to the list of analytes to clarify that hematologic assessments included a complete blood count with differential and a comprehensive metabolic panel, chemistry assessments included uric acid and phosphorus, and coagulation assessments included prothrombin time, partial thromboplastin time and fibrinogen. - The dose recommendations for cohorts in the dose escalation part of the study were revised to be guided by the escalation with overdose control (EWOC) principle, which mandates the dose for the next cohort to have less than 25% chance of excessive toxicity. - The terms prednisone and prednisolone were consistently updated to prednisone. - Eligibility criteria relating to renal function and prior plasma cell leukemia were clarified. - The schedules of assessment footnotes were clarified. - The possibility to use historical data (obtained up to 120 days prior to treatment start) for BM karyotyping and fluorescent in situ hybridization (FISH) was added. - The requirement to report pregnancies in a male participant's partner was added.
    14 Nov 2017
    - Clarified inclusion criteria for the dose expansion part of the protocol for participants who had not received a therapeutic CD38-targeting antibody. - Clarified no dose increases for the highest dose. - Restart guidance for CRS grade 3 was added and permanent discontinuation criteria were clarified. - Requested availability of 2 doses of tocilizumab per study participant in all countries where tocilizumab is available. - The list of possible dose level review team decisions was updated. - Eligibility criteria in the protocol synopsis were updated to be in line with the full list of inclusion criteria, ie, to reflect that participants must have received established and available therapies in order to be enrolled into the study. - The restriction stating that no study participant may receive AMG 701 treatment after the end of long term follow-up of the last participant in the study was deleted. - The requirement for HIV and latent tuberculosis testing at screening was added, as well as guidance on administration of tocilizumab for CRS management in case of latent tuberculosis. - Follow up with the sponsor medical monitor in case of overdose was updated to be mandatory. - Guidance for prevention and management of tumor lysis syndrome and corresponding references were added. - Clarified that storage time for laboratory samples depended on legal requirements in a country. - A description of assessments applicable in case of implementation of a treatment-free holiday for individual participants was added. - Updated schedules of assessments to clarify that in case of extended treatment-free intervals D36 assessments were to be repeated weekly, rather than D29 assessments, that screening for FISH and karyotyping data were obtained for participants enrolled into the dose exploration part of the study, and to include creatine clearance assessment at screening. - Allowed deviation windows for soluble BCMA. - Requirements for re-consenting were clarified.
    17 Jan 2018
    - The allowed window for on-site long term follow-up visits was increased from + 3 to + 7 days. - Inclusion criteria updated to state that participants must have received at least 2 prior lines of therapy in order to clarify that 1 line of prior therapy was not sufficient for inclusion, even if it included a proteasome inhibitor, an immunomodulatory drug and a CD38-directed cytolytic antibody. - Exclusion criteria updated for the washout time for prior therapeutic antibody treatment. This was reduced from 6 to 4 weeks as 6 weeks was considered excessive for patients who received this as their last line of treatment, particularly as no impact on participant safety was expected by this shorter washout time, given the described safety profile for the currently available anti-CD38 monoclonal antibody (daratumumab). - Japan and Canada were added to the study countries and number of sites updated to approximately 30. - The equivalent dose for methylprednisone was added to the premedication guidance. - Reference to administration of investigational product via syringe pumps was removed throughout the protocol as it does not apply in this study.
    19 Mar 2018
    - Hematologic DLT criteria were modified, and febrile neutropenia grade 4 was considered a DLT, regardless of duration.
    03 Dec 2018
    - Risk assessment of AMG 701 was updated to notate CRS as an identified risk and no longer a potential risk. - Specific CRS guidance was updated. - Permanent discontinuation of AMG 701 language was updated to correspond with changes to the Specific Guidance for CRS. - Eligibility criteria were updated for platelet threshold and baseline electrocardiogram. - Duration of infusion of AMG 701 was updated based on current practice of the protocol to correlate with the Investigational Product Instruction Manual. - Hematologic DLT of grade 4 thrombocytopenia was aligned with grade 3 thrombocytopenia DLT criteria. - Restart guidance was clarified for grade 3 or higher events for AMG 701 related AEs and grade 4 unrelated AEs. - Clarified anti-myeloma treatment could commence after end of treatment visit and not after safety follow-up visit. - Clarified immunofixation requirements for both serum and urine. - Serum and urine protein electrophoresis, serum free light chain and immunofixation were to be analyzed at the central laboratory in the dose expansion phase. - clarified requirements on electrocardiograms, deviation windows, medical history collection. - notation of D29 was removed from end of treatment. - Central disease assessment was added in the dose expansion, immune response testing and duplication between absolute neutrophil count and total neutrophils was removed. - clarification regarding In Vitro Diagnostic Medical Device for the minimal residual disease measurement.
    04 Mar 2019
    - Cohort extensions of up to 6 additional participants per dose level were to be implemented starting with dose level cohort 9, once the dose level review team judged this and later dose levels were safe. The rationale for these cohort extensions was to more completely assess the safety and activity of dose levels at the higher end of the current escalation scheme, due to the heterogeneity of disease burden and baseline soluble BCMA, which may be a major determinant of safety and efficacy of the investigational product. - Restart guidance for any other AMG 701 related events not meeting DLT criteria that are greater than or equal to grade 3, and any non-AMG 701 related events that are Grade 4 was updated to correct a contradiction in the grade notation between re-start guidance column and interruption/delay column to both be less than or equal to grade 2.
    23 Aug 2019
    - Addition of two new cohorts to the dose exploration part of the study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics, and efficacy of AMG 701, if needed to maximally tolerated dose. - Added option allowing the dose level review team to implement an earlier dose step, second dose step, or addition dose during C1. - Updated risk assessment of AMG 701 with focus given to CRS incidence by dose and severity to justify steroid predication tapering. - Added minimum hospitalization requirements for first dose of AMG 701 without glucocorticoid premedication and for subsequent intra-participant dose escalations. - Criteria for permanent discontinuation of AMG 701 were updated. - Minimum expected intervention and restart guidance in cases of grade 2 CRS were updated. - Exclusion criteria updated to clarify prior treatment with any drug or construct targeting BCMA on tumor cells and that participants with a prior history of prostate cancer with a Gleason score < 7 could be included. - Dose expansion part was updated to clarify dosing schedules. - Updated total number of planned participants for the phase 1 dose escalation part of the study to 75.
    19 Nov 2019
    - Added Phase 2 expansion. - Removed prior phase 1b expansion group to evaluate AMG 701 activity in participants who had not received an anti-CD38 monoclonal antibody. - Additional clinical data on preliminary efficacy of AMG 701 included. - Inclusion criteria were changed to reflect requirement for at least 3 lines of prior therapy and the requirement for prior CD38-targeted therapy. - Dose modification rules were added for the phase 2 portion. - Recommendations for serial imaging were provided, to permit investigators to monitor extramedullary disease burden and overall disease response per IMWG criteria. - Entry criteria for baseline hematologic function, specifically baseline platelet count for enrollment eligibility, were adjusted to more stringent requirement. - Removed 72 hour requirement for C2 guidance based on CRS in C1 during weeks 3 to 4. - Added AE management guidance for phase 2 portion, including dose reduction and discontinuation parameters for discrete event occurring on treatment. - Modified DLT criteria based on lipase and amylase elevations. - Clarified guidance on infusion reactions and tumor lysis syndrome. - Updated statement of hypothesis added and revisions to statistical analysis plan made to provide sample size justification for the phase 2 portion. - Prior allowance for “dose holidays” in the protocol was removed and was replaced by optional dosing-free intervals for participants achieving complete responses without detectable minimal residual disease using FDA-cleared MRD assay. - Addition of patient interviews for phase 1b portion and patient reported outcome measurement tools to phase 2 portion. - Removal of resburicase as an example of supportive care for tumor lysis syndrome, as based on current experience with AMG 701, the incidence of tumor lysis syndrome does not warrant specific treatment as prophylaxis.
    28 Jan 2020
    - Addition of one new cohort to the dose exploration part of the study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AMG 701, if needed to maximally tolerated dose. - Addition of new extended 1-week eIV cohorts to evaluate the safety, pharmacokinetics, and anti-myeloma activity associated with extended infusions given over either 7 days or 2 days. - Addition of new phase 1b dose-confirmation group to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AMG 701. - Protocol updated with new information on the target population rationale, with new information on BCMA-targeting bispecific antibody constructs in multiple myeloma. - Key benefits and risk updated with response data from the 20170122 study through 25 November 2019 and safety data through 29 August 2019, with focus to CRS incidence and potential for enhanced risk of infection. - Key secondary endpoints and objectives were updated. - Permitted extension of Cohorts 14 and 15 and to clarify that intra-participant dose escalation may be allowed in cases where participants have experienced Grade 2 CRS. - Updated planned number of participants in each part. - Clarified primary analysis and predicted exposure data, and updated information regarding administration of AMG 701 in the eIV cohorts. - Clarified criteria for restart and restart guidance for grade 2 infusion-related reactions. - Updated guidance for use of tocilizumab in cases of grade 3-4 CRS brief infusions and when AMG 701 given as an extended infusion. - Bone marrow biopsy collection requirements were updated and timing of myeloma disease response assessments were clarified.
    20 May 2020
    - Added additional treatment arms that include AMG 701 in combination with pomalidomide, with or without, dexamethasone. - Clarified minimum expected intervention for rigors associated with grade 1 CRS in participants enrolled in the monotherapy eIV group. - Updated guidance for restarting treatment with AMG 701 monotherapy in cases of certain grade 3 and grade 4 events. - Updated exclusion criteria to clarify instances when participant with known history of primary plasma cell leukemia may be allowed to enroll. - Streamlined schedules of activities for all study phases to minimized duplicate information.
    24 Jun 2020
    - Provided guidance to allow participants (who achieved at least PR) that had an AE of infection, to be able to resume AMG 701 treatment instead of having to permanently discontinue treatment when 2-consecutive doses of AMG 701 were missed.
    23 Dec 2020
    - Updated the key safety information for AMG 701 with details for hypophosphatemia as an identified risk following categorization of the safety signal as an Urgent Safety Measure and subsequent to the Dear Investigator letter. - Updated inclusion criteria to require a participant to have serum phosphorus ≥ 2.0 mg/dL (≥ 0.6 mmol/L) within 7 days of study Day 1. - Incorporated monitoring and management of guidelines for hypophosphatemia including providing phosphate replacement therapy and specific AMG 701 infusion withholding and stopping rules.
    09 Feb 2021
    - Updated to include CRS mitigation strategies to prevent > grade 1 CRS. - Updated the DLT criteria for phase 1/1b combination study. - Reduced the starting dose of AMG 701 for phase 1/1b combination study. - Removed the investigator attribution of relatedness from the DLT requirement for dose level review team consideration. - Clarified AMG 701 should be discontinued for any grade 4 non-hematologic AEs and all AEs should be considered for dose modification decisions. - Clarified participants may resume AMG 701 for any grade 3 non-hematologic AEs that resolved to less than or equal to grade 1 or baseline. - Clarified to discontinue study treatment if the participant missed more than 2 consecutive doses due to an AE. - Updated to include external members for the Data Review Team. - Updated schedule of activities to include pregnancy test every cycle for females of child-bearing age. - Updated Risk language to align with most recent data cutoff. - Removed Disease Related Events for all parts other than the phase 1 dose exploration monotherapy and added protocol-specific anticipated SAEs. - Added phase 2 objectives and endpoints and updated secondary endpoints. - Consolidated participants in Groups 1 and 2 and updated enrollment numbers. - Updated inclusion criteria to add Gilbert's syndrome as an exception for hepatic function. - Updated time points for biomarker sample collection and clarified participants discontinued from study treatment should discontinue laboratory and biomarker assessments except for safety follow-up and progression bone marrow. - Updated dosing details in justifications and for CRS prophylaxis. - Updated minimal residual disease treatment-free intervals, other protocol required therapies, restart guidance for CRS. - Added pneumonitis jirovecii prophylaxis and efficacy futility analysis.
    02 Apr 2021
    - Implemented stopping and dose holding rules for electrolyte abnormalities to further minimize safety risks. - Added hold of AMG 701 dosing for grade 3 non-hematologic AEs and hypophosphatemia AEs. - Added that AMG 701 should be permanently discontinued for any grade 4 electrolyte abnormalities and any Grade 4 non-hematologic toxicity. - Eligibility criteria updated to include related after ≥ 3 lines of prior therapy that must include all approved and available therapies including proteasome inhibitors, immunomodulators, and CD38 directed antibody. - Updated inclusion criteria to include normal electrolyte requirement or if abnormal, but be resolved to grade 1 within 7-days of Day 1. - Added QT assessment requirement and additional electrocardiogram timepoints at C1 and C3 and beyond. - Additional dose exploration cohort added. - Added normal saline 1-hour hydration to be co-administered with AMG 701 during C1.
    26 Oct 2021
    - Included the use of siltuximab as an alternative treatment of CRS when tocilizumab was not available.

    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.
    This study was discontinued for strategic reasons and not because of safety reasons or lack of efficacy. No participants were enrolled in Phase 1/1b of AMG 701 in combination with pomalidomide with and with without dexamethasone and Phase 2.
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    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.

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