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    Clinical Trial Results:
    A Phase 1b/2 Study of BMS-813160 in Combination with Chemotherapy or Nivolumab in Patients with Advanced Solid Tumors

    Summary
    EudraCT number
    2017-001725-40
    Trial protocol
    DE   ES   BE   IT  
    Global end of trial date
    14 Jun 2023

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

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    CV202-103
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussee de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.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
    14 Jun 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jun 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the safety and tolerability of BMS-813160 in combination with either FOLFIRI (Arm A), Gem + nab-paclitaxel (Arm B), or nivolumab (Arm C) in participants with advanced CRC or pancreatic cancer and to assess the pharmacodynamic effects of BMS-813160 in tumor samples
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial participants were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    08 Aug 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 27
    Country: Number of subjects enrolled
    United States: 252
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    Germany: 16
    Country: Number of subjects enrolled
    Spain: 24
    Country: Number of subjects enrolled
    Australia: 2
    Worldwide total number of subjects
    324
    EEA total number of subjects
    43
    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)
    201
    From 65 to 84 years
    121
    85 years and over
    2

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Participants in Cohort 1c were given the option to cross over to Cohort 8 if it’s in their best interest by their treating physician. Participants will have to meet all eligibility criteria to reenter the study, undergo baseline assessment and need a 28-day washout period prior to first dose of study treatment in the new arm.

    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
    Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
    Arm description
    First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer
    Arm type
    Experimental

    Investigational medicinal product name
    5-fluorouracil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    5-fluorouracil injection

    Investigational medicinal product name
    Irinotecan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Irinotecan injection

    Investigational medicinal product name
    Leucovorin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Leucovorin injection

    Investigational medicinal product name
    BMS-813160
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    BMS-813160 300 mg twice a day

    Arm title
    Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
    Arm description
    First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer
    Arm type
    Experimental

    Investigational medicinal product name
    BMS-813160
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    BMS-813160 600 mg once a day

    Investigational medicinal product name
    Leucovorin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Leucovorin injection

    Investigational medicinal product name
    Irinotecan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Irinotecan injection

    Investigational medicinal product name
    5-fluorouracil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    5-fluorouracil injection

    Arm title
    Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
    Arm description
    First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer
    Arm type
    Experimental

    Investigational medicinal product name
    BMS-813160
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    BMS-813160 300 mg twice a day

    Investigational medicinal product name
    Nab-paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nab-paclitaxel 100 mg injection

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine 1000 mg injection

    Arm title
    Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
    Arm description
    First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)
    Arm type
    Experimental

    Investigational medicinal product name
    BMS-813160
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    BMS-813160 600 mg once a day

    Investigational medicinal product name
    Nab-paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nab-paclitaxel 100 mg injection

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine 1000 mg injection

    Arm title
    Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
    Arm description
    Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
    Arm type
    Experimental

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nivolumab 10 mg/mL

    Investigational medicinal product name
    BMS-813160
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    BMS-813160 300 mg twice a day

    Arm title
    Part 1-Arm C-Chort 2: 2/3L CRC MSS/BMS600QD + NIVO
    Arm description
    Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
    Arm type
    Experimental

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nivolumab 10 mg/mL

    Investigational medicinal product name
    BMS-813160
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet, Tablet
    Routes of administration
    Oral use, Oral use
    Dosage and administration details
    BMS-813160 600 mg once a day

    Arm title
    Part 1-Arm C-Chort 3: 2/3L CRC MSS/BMS300QD + NIVO
    Arm description
    Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
    Arm type
    Experimental

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nivolumab 10 mg/mL

    Investigational medicinal product name
    BMS-813160
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    BMS-813160 300 mg once a day

    Arm title
    Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
    Arm description
    Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer
    Arm type
    Experimental

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nivolumab 10 mg/mL

    Investigational medicinal product name
    BMS-813160
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    BMS-813160 150 mg once a day

    Arm title
    Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
    Arm description
    Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
    Arm type
    Experimental

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nivolumab 10 mg/mL

    Investigational medicinal product name
    BMS-813160
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    BMS-813160 300 mg twice a day

    Arm title
    Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
    Arm description
    Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer
    Arm type
    Experimental

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nivolumab 10 mg/mL

    Investigational medicinal product name
    BMS-813160
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    BMS-813160 600 mg once a day

    Arm title
    Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
    Arm description
    Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer
    Arm type
    Experimental

    Investigational medicinal product name
    BMS-813160
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    BMS-813160 300 mg twice a day

    Investigational medicinal product name
    5-fluorouracil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    5-fluorouracil injection

    Investigational medicinal product name
    Leucovorin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Leucovorin injection

    Investigational medicinal product name
    Irinotecan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Irinotecan injection

    Arm title
    Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
    Arm description
    Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer
    Arm type
    Experimental

    Investigational medicinal product name
    BMS-813160
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    BMS-813160 150 mg once a day

    Investigational medicinal product name
    Leucovorin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Leucovorin injection

    Investigational medicinal product name
    Irinotecan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Irinotecan injection

    Investigational medicinal product name
    5-fluorouracil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    5-fluorouracil injection

    Arm title
    Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
    Arm description
    Second-line treatment FOLFIRI in participants with colorectal cancer
    Arm type
    Experimental

    Investigational medicinal product name
    5-fluorouracil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    5-fluorouracil injection

    Investigational medicinal product name
    Irinotecan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Irinotecan injection

    Investigational medicinal product name
    Leucovorin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Leucovorin injection

    Arm title
    Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
    Arm description
    First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer
    Arm type
    Experimental

    Investigational medicinal product name
    BMS-813160
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    BMS-813160 300 mg twice a day

    Investigational medicinal product name
    Nab-paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nab-paclitaxel 100 mg injection

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine 1000 mg injection

    Arm title
    Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
    Arm description
    First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer
    Arm type
    Experimental

    Investigational medicinal product name
    BMS-813160
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    BMS-813160 300 mg twice a day

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nivolumab 10 mg/mL

    Investigational medicinal product name
    Nab-paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nab-paclitaxel 100 mg injection

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine 1000 mg injection

    Arm title
    Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
    Arm description
    First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer
    Arm type
    Experimental

    Investigational medicinal product name
    Nab-paclitaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nab-paclitaxel 100 mg injection

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine 1000 mg injection

    Arm title
    Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
    Arm description
    Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer
    Arm type
    Experimental

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nivolumab 10 mg/mL

    Investigational medicinal product name
    BMS-813160
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    BMS-813160 300 mg twice a day

    Arm title
    Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
    Arm description
    Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer
    Arm type
    Experimental

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Nivolumab 10 mg/mL

    Investigational medicinal product name
    BMS-813160
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    BMS-813160 300 mg twice a day

    Number of subjects in period 1
    Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO Part 1-Arm C-Chort 2: 2/3L CRC MSS/BMS600QD + NIVO Part 1-Arm C-Chort 3: 2/3L CRC MSS/BMS300QD + NIVO Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
    Started
    10
    8
    10
    11
    8
    7
    7
    11
    1
    2
    32
    32
    26
    35
    35
    32
    24
    33
    Cross-over
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    9
    0
    0
    0
    0
    0
    Completed
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Not completed
    10
    8
    10
    11
    8
    7
    7
    11
    1
    2
    32
    32
    26
    35
    35
    32
    24
    33
         Adverse event, serious fatal
    6
    6
    8
    8
    6
    6
    6
    7
    1
    2
    26
    28
    17
    33
    34
    26
    20
    25
         Consent withdrawn by subject
    -
    -
    2
    1
    1
    -
    1
    -
    -
    -
    -
    2
    3
    -
    1
    5
    2
    2
         Other Reasons
    2
    2
    -
    1
    -
    -
    -
    2
    -
    -
    4
    2
    4
    -
    -
    1
    -
    4
         Lost to follow-up
    2
    -
    -
    1
    1
    1
    -
    2
    -
    -
    2
    -
    2
    2
    -
    -
    2
    2

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
    Reporting group description
    First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer

    Reporting group title
    Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
    Reporting group description
    First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer

    Reporting group title
    Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
    Reporting group description
    First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer

    Reporting group title
    Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
    Reporting group description
    First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)

    Reporting group title
    Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
    Reporting group description
    Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer

    Reporting group title
    Part 1-Arm C-Chort 2: 2/3L CRC MSS/BMS600QD + NIVO
    Reporting group description
    Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer

    Reporting group title
    Part 1-Arm C-Chort 3: 2/3L CRC MSS/BMS300QD + NIVO
    Reporting group description
    Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer

    Reporting group title
    Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
    Reporting group description
    Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer

    Reporting group title
    Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
    Reporting group description
    Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer

    Reporting group title
    Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
    Reporting group description
    Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer

    Reporting group title
    Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
    Reporting group description
    Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer

    Reporting group title
    Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
    Reporting group description
    Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer

    Reporting group title
    Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
    Reporting group description
    Second-line treatment FOLFIRI in participants with colorectal cancer

    Reporting group title
    Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
    Reporting group description
    First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer

    Reporting group title
    Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
    Reporting group description
    First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer

    Reporting group title
    Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
    Reporting group description
    First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer

    Reporting group title
    Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
    Reporting group description
    Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer

    Reporting group title
    Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
    Reporting group description
    Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer

    Reporting group values
    Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO Part 1-Arm C-Chort 2: 2/3L CRC MSS/BMS600QD + NIVO Part 1-Arm C-Chort 3: 2/3L CRC MSS/BMS300QD + NIVO Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO Total
    Number of subjects
    10 8 10 11 8 7 7 11 1 2 32 32 26 35 35 32 24 33 324
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    4 5 5 7 6 6 7 8 1 2 25 21 20 13 16 15 11 29 201
        From 65-84 years
    6 3 5 4 2 1 0 3 0 0 7 11 6 22 17 17 13 4 121
        85 years and over
    0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 2
    Age Continuous
    Units: Years
        arithmetic mean (full range (min-max))
    65.6 (54 to 83) 53.3 (28 to 66) 64.1 (54 to 80) 62.7 (51 to 80) 59.5 (48 to 76) 61.7 (52 to 66) 45.1 (33 to 57) 60.5 (42 to 77) 61.0 (61 to 61) 50.0 (49 to 51) 55.0 (29 to 76) 58.9 (30 to 83) 57.9 (37 to 77) 65.9 (46 to 76) 65.3 (43 to 85) 65.5 (49 to 84) 63.9 (34 to 77) 55.0 (39 to 69) -
    Sex: Female, Male
    Units: Participants
        Female
    3 2 6 6 2 3 3 3 1 0 13 11 9 15 15 15 8 18 133
        Male
    7 6 4 5 6 4 4 8 0 2 19 21 17 20 20 17 16 15 191
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Asian
    1 3 0 0 0 1 0 2 0 0 2 2 1 2 1 1 1 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
        Black or African American
    1 0 0 0 0 1 0 0 0 0 1 3 2 0 0 2 0 3 13
        White
    8 4 10 11 8 5 7 7 1 2 28 26 22 32 34 27 22 28 282
        More than one race
    0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Unknown or Not Reported
    0 1 0 0 0 0 0 2 0 0 1 1 1 1 0 2 1 1 11
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    0 0 1 1 0 0 0 3 0 0 7 2 2 2 1 4 0 4 27
        Not Hispanic or Latino
    8 5 8 9 8 7 6 7 0 2 21 26 17 28 30 24 21 23 250
        Unknown or Not Reported
    2 3 1 1 0 0 1 1 1 0 4 4 7 5 4 4 3 6 47

    End points

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    End points reporting groups
    Reporting group title
    Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI
    Reporting group description
    First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer

    Reporting group title
    Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI
    Reporting group description
    First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer

    Reporting group title
    Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB
    Reporting group description
    First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer

    Reporting group title
    Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB
    Reporting group description
    First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)

    Reporting group title
    Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO
    Reporting group description
    Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer

    Reporting group title
    Part 1-Arm C-Chort 2: 2/3L CRC MSS/BMS600QD + NIVO
    Reporting group description
    Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer

    Reporting group title
    Part 1-Arm C-Chort 3: 2/3L CRC MSS/BMS300QD + NIVO
    Reporting group description
    Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer

    Reporting group title
    Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO
    Reporting group description
    Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer

    Reporting group title
    Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO
    Reporting group description
    Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer

    Reporting group title
    Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO
    Reporting group description
    Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer

    Reporting group title
    Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI
    Reporting group description
    Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer

    Reporting group title
    Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI
    Reporting group description
    Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer

    Reporting group title
    Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI
    Reporting group description
    Second-line treatment FOLFIRI in participants with colorectal cancer

    Reporting group title
    Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB
    Reporting group description
    First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer

    Reporting group title
    Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO
    Reporting group description
    First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer

    Reporting group title
    Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB
    Reporting group description
    First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer

    Reporting group title
    Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO
    Reporting group description
    Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer

    Reporting group title
    Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
    Reporting group description
    Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer

    Primary: Number of Participants Experiencing Adverse Events (AEs)

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    End point title
    Number of Participants Experiencing Adverse Events (AEs) [1]
    End point description
    An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
    End point type
    Primary
    End point timeframe
    From first dose up to 100 days post last dose, up to approximately 3 years
    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: Summary statistics only were planned for this endpoint
    End point values
    Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO Part 1-Arm C-Chort 2: 2/3L CRC MSS/BMS600QD + NIVO Part 1-Arm C-Chort 3: 2/3L CRC MSS/BMS300QD + NIVO Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
    Number of subjects analysed
    10
    8
    10
    11
    8
    7
    7
    11
    1
    2
    32
    32
    26
    35
    35
    32
    24
    33
    Units: Participants
    10
    8
    10
    11
    8
    7
    7
    11
    1
    2
    32
    32
    25
    35
    35
    31
    23
    32
    No statistical analyses for this end point

    Primary: Number of Participants Experiencing Serious Adverse Events (SAEs)

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    End point title
    Number of Participants Experiencing Serious Adverse Events (SAEs) [2]
    End point description
    A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.
    End point type
    Primary
    End point timeframe
    From first dose up to 100 days post last dose, up to approximately 3 years
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Summary statistics only were planned for this endpoint
    End point values
    Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO Part 1-Arm C-Chort 2: 2/3L CRC MSS/BMS600QD + NIVO Part 1-Arm C-Chort 3: 2/3L CRC MSS/BMS300QD + NIVO Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
    Number of subjects analysed
    10
    8
    10
    11
    8
    7
    7
    11
    1
    2
    32
    32
    26
    35
    35
    32
    24
    33
    Units: Participants
    5
    5
    5
    7
    5
    6
    6
    6
    1
    2
    12
    12
    6
    24
    22
    15
    17
    19
    No statistical analyses for this end point

    Primary: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)

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    End point title
    Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) [3]
    End point description
    Dose-limiting toxicities (DLTs) are severe adverse effects (AEs) that are attributed to BMS-813160 or the combination regimen and define the maximum tolerated dose of a medicine. DLTs will be defined based on the incidence, duration and grade of AEs for which no alternate cause can be identified. AEs will be evaluated according to the NCI CTCAE v4.03. The incidence of DLT(s) during the first 6 weeks of treatment in Part 1 (the DLT evaluation period) and 4 weeks for Part 2 will be used.
    End point type
    Primary
    End point timeframe
    From first dose up to 100 days post last dose, up to approximately 3 years
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Summary statistics only were planned for this endpoint
    End point values
    Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO Part 1-Arm C-Chort 2: 2/3L CRC MSS/BMS600QD + NIVO Part 1-Arm C-Chort 3: 2/3L CRC MSS/BMS300QD + NIVO Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
    Number of subjects analysed
    10
    8
    10
    11
    8
    7
    7
    11
    1
    2
    32
    32
    26
    35
    35
    32
    24
    33
    Units: Participants
    0
    0
    2
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation

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    End point title
    Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation [4]
    End point description
    An Adverse Event (AE) leading to discontinuation is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment that leads to the discontinuation of study treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
    End point type
    Primary
    End point timeframe
    From first dose up to 100 days post last dose, up to approximately 3 years
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Summary statistics only were planned for this endpoint
    End point values
    Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO Part 1-Arm C-Chort 2: 2/3L CRC MSS/BMS600QD + NIVO Part 1-Arm C-Chort 3: 2/3L CRC MSS/BMS300QD + NIVO Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
    Number of subjects analysed
    10
    8
    10
    11
    8
    7
    7
    11
    1
    2
    32
    32
    26
    35
    35
    32
    24
    33
    Units: Participants
    2
    0
    1
    6
    0
    1
    0
    1
    0
    1
    10
    6
    2
    12
    8
    3
    4
    2
    No statistical analyses for this end point

    Primary: Number of Participants who Died

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    End point title
    Number of Participants who Died [5]
    End point description
    The number of participants who died within 100 days of the last dose of treatment
    End point type
    Primary
    End point timeframe
    From first dose up to 100 days post last dose, up to approximately 3 years
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Summary statistics only were planned for this endpoint
    End point values
    Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO Part 1-Arm C-Chort 2: 2/3L CRC MSS/BMS600QD + NIVO Part 1-Arm C-Chort 3: 2/3L CRC MSS/BMS300QD + NIVO Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
    Number of subjects analysed
    10
    8
    10
    11
    8
    7
    7
    11
    1
    2
    32
    32
    26
    35
    35
    32
    24
    33
    Units: Participants
    6
    6
    8
    8
    6
    6
    6
    7
    1
    2
    26
    28
    17
    33
    34
    26
    20
    25
    No statistical analyses for this end point

    Primary: Number of Participants Experiencing Laboratory Abnormalities

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    End point title
    Number of Participants Experiencing Laboratory Abnormalities [6]
    End point description
    The number of participants experiencing laboratory abnormalities in pre-specified selected parameters during the treatment period per CTCAE (Version 4). Laboratory abnormalities are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.
    End point type
    Primary
    End point timeframe
    From first dose up to 100 days post last dose, up to approximately 3 years
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Summary statistics only were planned for this endpoint
    End point values
    Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO Part 1-Arm C-Chort 2: 2/3L CRC MSS/BMS600QD + NIVO Part 1-Arm C-Chort 3: 2/3L CRC MSS/BMS300QD + NIVO Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
    Number of subjects analysed
    10
    8
    10
    11
    8
    7
    7
    11
    1
    2
    32
    32
    26
    35
    35
    32
    24
    33
    Units: Participants
        ALT (U/L) - Abnormal High
    2
    4
    5
    7
    2
    1
    3
    6
    1
    1
    15
    9
    10
    24
    28
    24
    10
    13
        AST (U/L) - Abnormal High
    2
    4
    5
    7
    3
    3
    5
    5
    1
    1
    15
    12
    9
    21
    26
    24
    12
    19
        Total Bilirubin (UMOL/L) - Abnormal High
    2
    4
    5
    2
    1
    1
    4
    3
    1
    1
    5
    5
    2
    8
    7
    5
    6
    7
        Neutrophils (Absolute) (10^9/L) - Abnormal Low
    6
    4
    5
    9
    2
    1
    1
    2
    0
    0
    25
    20
    18
    22
    25
    25
    1
    4
        PLATELET COUNT (10^9/L) - Abnormal Low
    5
    1
    5
    5
    2
    1
    1
    3
    0
    0
    11
    15
    8
    24
    28
    26
    10
    5
    No statistical analyses for this end point

    Primary: Vital Signs

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    End point title
    Vital Signs [7]
    End point description
    Vital sign measurements at baseline and at the end of treatment. Vital signs measurements include systolic blood pressure and diastolic blood pressure. "99999"=N/A
    End point type
    Primary
    End point timeframe
    From first dose to 100 days post last dose, up to approximately 3 years
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Summary statistics only were planned for this endpoint
    End point values
    Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO Part 1-Arm C-Chort 2: 2/3L CRC MSS/BMS600QD + NIVO Part 1-Arm C-Chort 3: 2/3L CRC MSS/BMS300QD + NIVO Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
    Number of subjects analysed
    10
    7
    9
    11
    8
    6
    7
    10
    1
    2
    32
    31
    26
    34
    34
    32
    23
    31
    Units: mmHg
    arithmetic mean (standard deviation)
        Systolic Blood Pressure (mmHg) - Follow-up
    140.0 ( 8.5 )
    124.5 ( 2.1 )
    100.0 ( 99999 )
    143.0 ( 34.0 )
    140.0 ( 8.5 )
    108.0 ( 99999 )
    148.0 ( 99999 )
    129.5 ( 29.0 )
    99999 ( 99999 )
    99999 ( 99999 )
    127.9 ( 13.2 )
    131.3 ( 20.6 )
    127.3 ( 14.4 )
    130.7 ( 22.6 )
    133.9 ( 15.9 )
    127.1 ( 18.2 )
    121.3 ( 16.3 )
    128.1 ( 20.3 )
        Systolic Blood Pressure (mmHg) - End of Treatment
    133.0 ( 99999 )
    129.7 ( 6.7 )
    130.2 ( 21.8 )
    143.0 ( 34.0 )
    114.0 ( 15.0 )
    125.0 ( 6.1 )
    140.3 ( 18.0 )
    124.0 ( 23.7 )
    151.0 ( 99999 )
    107.0 ( 99999 )
    126.0 ( 15.9 )
    113.0 ( 99999 )
    113.0 ( 99999 )
    123.2 ( 18.8 )
    128.9 ( 17.8 )
    118.8 ( 15.9 )
    112.6 ( 11.6 )
    123.1 ( 13.6 )
        Diastolic Blood Pressure (mmHg) - Follow-up
    79.0 ( 99999 )
    71.5 ( 14.8 )
    59.0 ( 99999 )
    99999 ( 99999 )
    85.0 ( 2.8 )
    69.0 ( 99999 )
    98.0 ( 99999 )
    72.5 ( 4.9 )
    99999 ( 99999 )
    99999 ( 99999 )
    76.6 ( 14.6 )
    76.1 ( 11.0 )
    78.2 ( 7.3 )
    68.0 ( 9.9 )
    70.2 ( 10.5 )
    66.7 ( 20.1 )
    85.0 ( 99999 )
    69.0 ( 2.8 )
        Diastolic Blood Pressure (mmHg) - End of Treatment
    83.0 ( 99999 )
    73.3 ( 7.2 )
    75.4 ( 12.4 )
    80.8 ( 17.7 )
    69.6 ( 9.4 )
    86.0 ( 18.2 )
    89.7 ( 11.1 )
    74.3 ( 11.3 )
    86.0 ( 99999 )
    67.0 ( 99999 )
    79.0 ( 11.5 )
    74.5 ( 3.5 )
    75.0 ( 99999 )
    69.2 ( 8.2 )
    74.3 ( 8.6 )
    70.2 ( 8.6 )
    68.1 ( 6.5 )
    74.3 ( 9.7 )
    No statistical analyses for this end point

    Primary: Number of Participants with Out-of-Range Electrocardiograms (ECG)

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    End point title
    Number of Participants with Out-of-Range Electrocardiograms (ECG) [8]
    End point description
    The number of participants with ECG measurements outside of the range pre-specified in the protocol.
    End point type
    Primary
    End point timeframe
    From baseline up to 100 days post last dose
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Summary statistics only were planned for this endpoint
    End point values
    Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO Part 1-Arm C-Chort 2: 2/3L CRC MSS/BMS600QD + NIVO Part 1-Arm C-Chort 3: 2/3L CRC MSS/BMS300QD + NIVO Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
    Number of subjects analysed
    10
    8
    10
    10
    8
    7
    7
    11
    1
    2
    32
    31
    25
    34
    34
    29
    24
    33
    Units: Participants
        QTcF INTERVAL (MSEC) < 450
    7
    8
    10
    8
    8
    7
    7
    10
    1
    2
    31
    27
    23
    26
    30
    26
    24
    31
        QTcF INTERVAL (MSEC): 450 <= QTcF < 480
    3
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    4
    2
    6
    4
    3
    0
    2
        480<=QTcF<500 (MSEC)
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
        QTcF>= 500 (MSEC)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
        QTcB INTERVAL (MSEC) < 450
    4
    7
    8
    5
    7
    3
    3
    7
    1
    2
    20
    21
    15
    14
    17
    19
    21
    15
        450<=QTcB<480 (MSEC)
    5
    1
    1
    3
    1
    4
    3
    2
    0
    0
    11
    7
    10
    14
    14
    8
    3
    18
        480<=QTcB<500 (MSEC)
    1
    0
    1
    2
    0
    0
    1
    2
    0
    0
    0
    3
    0
    4
    3
    2
    0
    0
        QTcB>= 500 (MSEC)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    2
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percent Change in Regulatory T Cells (Treg) and Tumor-Associated Macrophages (TAMs) in Tumor Samples

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    End point title
    Percent Change in Regulatory T Cells (Treg) and Tumor-Associated Macrophages (TAMs) in Tumor Samples [9]
    End point description
    The percent change in Regulatory T Cells (Treg) and Tumor-Associated Macrophages (TAMs) were taken at prespecified timepoints. Baseline is defined as the last non-missing value prior to the first dosing. "99999"=N/A
    End point type
    Primary
    End point timeframe
    From first dose up to prespecified timepoints
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Summary statistics only were planned for this endpoint
    End point values
    Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO Part 1-Arm C-Chort 2: 2/3L CRC MSS/BMS600QD + NIVO Part 1-Arm C-Chort 3: 2/3L CRC MSS/BMS300QD + NIVO Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
    Number of subjects analysed
    10
    8
    10
    11
    8
    7
    7
    11
    1
    2
    32
    32
    26
    35
    35
    32
    24
    33
    Units: Percent change
    median (full range (min-max))
        CD163 Positive - C0D7
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    13.1 (2 to 808)
    -12.7 (-67 to 231)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        CD163 Positive - C0D14
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    95.4 (34 to 157)
    133.6 (0 to 286)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        CD163 Positive - C1D1
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    477.5 (334 to 621)
    22.1 (-28 to 520)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        CD163 Positive - C1D15
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    7.6 (-37 to 53)
    -93 (-93 to -93)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    89.8 (35 to 132)
    -61 (-61 to -61)
    145.7 (43 to 248)
    99999 (99999 to 99999)
    60.3 (1 to 120)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        CD163 Positive - C1D16
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    1369 (1369 to 1369)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        CD163 Positive - C1D28
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    -4.1 (-21 to 1072)
    -58.4 (-98 to -19)
    106.3 (-67 to 511)
    -14.7 (-57 to 91)
    65.5 (-31 to 666)
    1.0 (-96 to 61)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        CD163 Positive - C2D1
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    -58.3 (-94 to -22)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    -41.3 (-61 to -33)
    99999 (99999 to 99999)
    39.3 (-1 to 79)
        CD68 Positive - C0D7
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    -70.2 (-91 to 107)
    -17.1 (-64 to -2)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        CD68 Positive - C0D14
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    57.7 (-12 to 128)
    7.9 (-8 to 24)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        CD68 Positive - C1D1
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    294.2 (203 to 385)
    17.8 (-39 to 102)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        CD68 Positive - C1D15
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    2.9 (-26 to 185)
    -26 (-26 to -26)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    -4.0 (-27 to 58)
    81 (81 to 81)
    162.4 (150 to 175)
    99999 (99999 to 99999)
    92.5 (20 to 165)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        CD68 Positive - C1D16
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    272 (272 to 272)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        CD68 Positive - C1D28
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    31.5 (-60 to 296)
    -70.7 (-92 to -49)
    96.2 (-50 to 1106)
    -38.3 (-88 to 121)
    96.2 (-25 to 179)
    -4.3 (-46 to 102)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        CD68 Positive - C2D1
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    -26.9 (-50 to -4)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    -40.0 (-54 to -33)
    99999 (99999 to 99999)
    -66 (-66 to -66)
        FOXP3 - C0D7
    26.6 (-67 to 180)
    -43.8 (-58 to -15)
    -22.9 (-74 to -14)
    156.4 (-12 to 177)
    57.3 (-76 to 116)
    -18.4 (-27 to -9)
    -92.2 (-94 to 27)
    96.4 (14 to 152)
    99999 (99999 to 99999)
    101.0 (101 to 101)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        FOXP3 - C0D14
    26.5 (-50 to 103)
    -19.8 (-78 to 53)
    60.0 (60 to 60)
    -41.6 (-67 to -16)
    -41 (-41 to -41)
    -26.5 (-57 to 249)
    180.2 (-60 to 421)
    -3.7 (-9 to 25)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        FOXP3 - C1D1
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    34.7 (-58 to 128)
    49 (49 to 49)
    147.4 (20 to 275)
    33.0 (-51 to 338)
    99999 (99999 to 99999)
    31.0 (31 to 31)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        FOXP3 - C1D15
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    -25.9 (-48 to -6)
    14.5 (-90 to 322)
    39.1 (4 to 74)
    -33 (-33 to -33)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    -39.1 (-46 to -32)
    60 (60 to 60)
    113.6 (-1 to 228)
    99999 (99999 to 99999)
    17.0 (-39 to 73)
    -64 (-64 to -64)
    99999 (99999 to 99999)
        FOXP3 - C1D16
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    -21 (-21 to -21)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
        FOXP3 - C1D28
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    -7.4 (-26 to 113)
    -77.0 (-93 to -61)
    12.0 (-73 to 152)
    -36.0 (-77 to -5)
    99.4 (-96 to 2199)
    -46.6 (-55 to 551)
    216.7 (98 to 363)
    -13.6 (-78 to 149)
        FOXP3 - C2D1
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    305.2 (-73 to 683)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    184 (184 to 184)
    -2.4 (-37 to 32)
    156.2 (13 to 299)
    No statistical analyses for this end point

    Primary: Objective Response Rate (ORR)

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    End point title
    Objective Response Rate (ORR) [10]
    End point description
    Objective Response Rate (ORR) as determined by Investigator was defined as the number of participants with a best overall response of confirmed Complete Response (CR) or Partial Response (PR) (per RECIST 1.1 criteria) divided by the number of all treated participants. Progression is defined as at least 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. RECIST 1.1 = Response Evaluation Criteria in Solid Tumors. Complete response (CR)= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial response (PR)= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
    End point type
    Primary
    End point timeframe
    From first dose until disease progression, or the last response recorded, approximately 3 years
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Summary statistics only were planned for this endpoint
    End point values
    Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO Part 1-Arm C-Chort 2: 2/3L CRC MSS/BMS600QD + NIVO Part 1-Arm C-Chort 3: 2/3L CRC MSS/BMS300QD + NIVO Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
    Number of subjects analysed
    10
    8
    10
    11
    8
    7
    7
    11
    1
    2
    32
    32
    26
    35
    35
    32
    24
    24
    Units: Percent of participants
        number (confidence interval 95%)
    60.0 (26.2 to 87.8)
    25.0 (3.2 to 65.1)
    0 (0.0 to 30.8)
    18.2 (2.3 to 51.8)
    0 (0.0 to 36.9)
    0 (0.0 to 41.0)
    0 (0.0 to 41.0)
    0 (0.0 to 28.5)
    0 (0.0 to 97.5)
    0 (0.0 to 84.2)
    9.4 (2.0 to 25.0)
    9.4 (2.0 to 25.0)
    19.2 (6.6 to 39.4)
    22.9 (10.4 to 40.1)
    17.1 (6.6 to 33.6)
    21.9 (9.3 to 40.0)
    0 (0.0 to 14.2)
    8.3 (1.0 to 27.0)
    No statistical analyses for this end point

    Primary: Duration of Response (DoR)

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    End point title
    Duration of Response (DoR) [11]
    End point description
    Duration of Response (DOR), computed for all treated participants with a best overall response (BOR) of complete response (CR) or partial response (PR), is defined as the time between the date of first response (CR or PR) and the date of first documented disease progression as determined by RECIST 1.1 or death due to any cause, whichever occurs first, ie., DOR = disease progression date/death date -first response date + 1. For participants who remain alive and have not progressed, DOR will be censored on the date of their last tumor assessment. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. "99999"=N/A
    End point type
    Primary
    End point timeframe
    From first response up to date of disease progression or death, whichever occurs first (up to approximately 5 years)
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Summary statistics only were planned for this endpoint
    End point values
    Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO Part 1-Arm C-Chort 2: 2/3L CRC MSS/BMS600QD + NIVO Part 1-Arm C-Chort 3: 2/3L CRC MSS/BMS300QD + NIVO Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
    Number of subjects analysed
    6
    2
    0 [12]
    2
    0 [13]
    0 [14]
    0 [15]
    0 [16]
    0 [17]
    0 [18]
    3
    3
    5
    7
    6
    7
    0 [19]
    2
    Units: Weeks
        median (confidence interval 95%)
    159.00 (47.00 to 99999)
    99999 (16.43 to 99999)
    ( to )
    99999 (24.14 to 99999)
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    ( to )
    74.14 (32.14 to 99999)
    56.57 (40.17 to 99999)
    36.21 (16.14 to 99999)
    32.14 (17.14 to 37.29)
    37.14 (14.14 to 99999)
    20.57 (14.29 to 31.00)
    ( to )
    99999 (41.00 to 99999)
    Notes
    [12] - Median, lower, and upper limited not calculated due to insufficient number of events
    [13] - Median, lower, and upper limited not calculated due to insufficient number of events
    [14] - Median, lower, and upper limited not calculated due to insufficient number of events
    [15] - Median, lower, and upper limited not calculated due to insufficient number of events
    [16] - Median, lower, and upper limited not calculated due to insufficient number of events
    [17] - Median, lower, and upper limited not calculated due to insufficient number of events
    [18] - Median, lower, and upper limited not calculated due to insufficient number of events
    [19] - Median, lower, and upper limited not calculated due to insufficient number of events
    No statistical analyses for this end point

    Primary: Progression Free Survival (PFS) Rate at 24 Weeks

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    End point title
    Progression Free Survival (PFS) Rate at 24 Weeks [20]
    End point description
    PFS rate is defined as the percentage of participants who were progression free at Week 24. PFS is defined as the time from first dose to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Progression is defined at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. Complete response (CR)= Disappearance of all target lesions. Pathological lymph nodes must have short axis reduction to < 10 mm. Partial response (PR)= At least 30% decrease in sum of diameters of target lesions. Participants who died w/o prior progression were considered progressed on death date. Those alive and not progressed were censored on the last tumor assessment date. Those who started subsequent therapy without reported progression were censored at last tumor assessment prior to subsequent therapy. Those without post-baseline tumor assessment and alive were censored at first dose.
    End point type
    Primary
    End point timeframe
    From first dose up to Week 24
    Notes
    [20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Summary statistics only were planned for this endpoint
    End point values
    Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO Part 1-Arm C-Chort 2: 2/3L CRC MSS/BMS600QD + NIVO Part 1-Arm C-Chort 3: 2/3L CRC MSS/BMS300QD + NIVO Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
    Number of subjects analysed
    7
    4
    5
    6
    0 [21]
    0 [22]
    0 [23]
    1
    0 [24]
    0 [25]
    7
    14
    13
    17
    21
    13
    0 [26]
    3
    Units: Percentage of Participants
        number (confidence interval 95%)
    0.778 (0.3648 to 0.9393)
    99999 (99999 to 99999)
    0.556 (0.2042 to 0.8045)
    0.800 (0.4087 to 0.9459)
    ( to )
    ( to )
    ( to )
    99999 (99999 to 99999)
    ( to )
    ( to )
    0.357 (0.1699 to 0.5490)
    0.536 (0.3372 to 0.6996)
    0.691 (0.4361 to 0.8478)
    0.535 (0.3512 to 0.6888)
    0.636 (0.4495 to 0.7746)
    0.467 (0.2779 to 0.6358)
    ( to )
    99999 (99999 to 99999)
    Notes
    [21] - Not calculated due to insufficient number of events
    [22] - Not calculated due to insufficient number of events
    [23] - Not calculated due to insufficient number of events
    [24] - Not calculated due to insufficient number of events
    [25] - Not calculated due to insufficient number of events
    [26] - Not calculated due to insufficient number of events
    No statistical analyses for this end point

    Secondary: Maximim Concentration (Cmax)

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    End point title
    Maximim Concentration (Cmax)
    End point description
    Cmax is defined as the maximum plasma concentration of the analytes at the prespecified timepoints. "99999"=N/A
    End point type
    Secondary
    End point timeframe
    From first dose up to the prespecified timepoints, C0D1, C0D14, AND C2D1
    End point values
    Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO Part 1-Arm C-Chort 2: 2/3L CRC MSS/BMS600QD + NIVO Part 1-Arm C-Chort 3: 2/3L CRC MSS/BMS300QD + NIVO Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
    Number of subjects analysed
    10
    7
    10
    10
    8
    7
    7
    6
    1
    2
    18
    15
    0 [27]
    20
    0 [28]
    0 [29]
    0 [30]
    0 [31]
    Units: ng/mL
    arithmetic mean (standard deviation)
        C0D1 - BMS-813160
    620.4 ( 250.60 )
    2204.1 ( 961.90 )
    828.4 ( 458.03 )
    2419.0 ( 1203.53 )
    486.3 ( 137.69 )
    1896.3 ( 1421.89 )
    1179.1 ( 605.50 )
    276.28 ( 141.915 )
    1580.0 ( 99999 )
    807.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    ( )
        C0D1 - BMS-939429
    172.23 ( 103.837 )
    435.6 ( 284.14 )
    207.63 ( 142.559 )
    545.7 ( 218.89 )
    92.33 ( 50.015 )
    539.1 ( 465.93 )
    237.63 ( 188.286 )
    54.82 ( 23.716 )
    504.0 ( 99999 )
    72.50 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    ( )
        C0D14 - BMS-813160
    927.1 ( 513.88 )
    4152.5 ( 2010.23 )
    1060.3 ( 830.04 )
    3274.0 ( 884.15 )
    701.5 ( 284.59 )
    1793.5 ( 1607.25 )
    653.3 ( 298.08 )
    80.00 ( 19.408 )
    1370.0 ( 99999 )
    1680.0 ( 961.67 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    ( )
        C0D14 - BMS-939429
    317.90 ( 290.209 )
    658.3 ( 143.17 )
    409.63 ( 382.471 )
    792.2 ( 503.92 )
    183.08 ( 190.050 )
    326.0 ( 241.83 )
    165.83 ( 92.914 )
    25.307 ( 16.6021 )
    498.0 ( 99999 )
    265.40 ( 235.608 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    ( )
        C2D1 - BMS-813160
    1153.1 ( 617.97 )
    3280.0 ( 777.82 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    903.9 ( 578.56 )
    357.55 ( 264.384 )
    ( )
    796.2 ( 472.48 )
    ( )
    ( )
    ( )
    ( )
        C2D1 - BMS-939429
    254.1 ( 140.73 )
    571.0 ( 376.42 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    ( )
    Notes
    [27] - Cmax not calculated because there was an insufficient number of participants with evaluable data
    [28] - Cmax not calculated because there was an insufficient number of participants with evaluable data
    [29] - Cmax not calculated because there was an insufficient number of participants with evaluable data
    [30] - Cmax not calculated because there was an insufficient number of participants with evaluable data
    [31] - Cmax not calculated because there was an insufficient number of participants with evaluable data
    No statistical analyses for this end point

    Secondary: Time to Maximum Concentration (Tmax)

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    End point title
    Time to Maximum Concentration (Tmax)
    End point description
    Tmax is defined as the time in hours of the maximum observed plasma concentration
    End point type
    Secondary
    End point timeframe
    From first dose up to the prespecified timpoints, C0D1, C0D14, AND C2D1
    End point values
    Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO Part 1-Arm C-Chort 2: 2/3L CRC MSS/BMS600QD + NIVO Part 1-Arm C-Chort 3: 2/3L CRC MSS/BMS300QD + NIVO Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
    Number of subjects analysed
    10
    7
    10
    10
    8
    7
    7
    6
    1
    2
    18
    15
    0 [32]
    20
    0 [33]
    0 [34]
    0 [35]
    0 [36]
    Units: Hours
    median (full range (min-max))
        C0D1 - BMS-813160
    2.000 (0.50 to 4.00)
    0.500 (0.47 to 4.00)
    3.017 (2.00 to 4.02)
    2.492 (0.73 to 5.98)
    2.492 (0.52 to 11.92)
    2.983 (0.58 to 8.92)
    3.00 (0.50 to 6.00)
    1.992 (0.50 to 3.00)
    2.0 (2 to 2)
    3.950 (3.95 to 3.95)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
    99999 (99999 to 99999)
    ( to )
    ( to )
    ( to )
    ( to )
        C0D1 - BMS-939429
    3.500 (0.50 to 6.25)
    1.000 (0.50 to 4.00)
    3.508 (1.00 to 11.98)
    3.000 (0.73 to 5.98)
    3.000 (1.0 to 11.92)
    2.083 (1.08 to 8.92)
    3.000 (1.00 to 6.00)
    2.000 (0.98 to 4.00)
    2.0 (2 to 2)
    1.950 (1.95 to 1.95)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
    99999 (99999 to 99999)
    ( to )
    ( to )
    ( to )
    ( to )
        C0D14 - BMS-813160
    3.000 (0.55 to 3.03)
    1.825 (0.50 to 3.00)
    2.917 (0.92 to 15.70)
    2.983 (0.50 to 4.00)
    2.875 (0.50 to 3.00)
    2.0 (1 to 3)
    2.000 (1.00 to 3.02)
    1.00 (0.5 to 4.0)
    2.02 (2.02 to 2.02)
    2.542 (2.00 to 3.08)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
    99999 (99999 to 99999)
    ( to )
    ( to )
    ( to )
    ( to )
        C0D14 - BMS-939429
    3.000 (0.98 to 4.00)
    1.825 (0.50 to 3.00)
    3.000 (1.08 to 15.70)
    2.983 (1.00 to 4.00)
    2.875 (1.17 to 3.00)
    2.492 (1.98 to 3.00)
    3.000 (1.00 to 4.02)
    1.0 (1 to 6)
    2.02 (2.02 to 2.02)
    3.117 (2.00 to 4.23)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
    99999 (99999 to 99999)
    ( to )
    ( to )
    ( to )
    ( to )
        C2D1 - BMS-813160
    3.000 (0.98 to 4.23)
    1.000 (0.47 to 4.03)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    2.033 (0.50 to 14.10)
    2.067 (0.50 to 8.10)
    ( to )
    3.992 (0.50 to 16.17)
    ( to )
    ( to )
    ( to )
    ( to )
        C2D1 - BMS-939429
    3.000 (2.00 to 4.23)
    1.000 (0.97 to 4.03)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    ( to )
    99999 (99999 to 99999)
    ( to )
    ( to )
    ( to )
    ( to )
    Notes
    [32] - Tmax not calculated because there was an insufficient number of participants with evaluable data
    [33] - Tmax not calculated because there was an insufficient number of participants with evaluable data
    [34] - Tmax not calculated because there was an insufficient number of participants with evaluable data
    [35] - Tmax not calculated because there was an insufficient number of participants with evaluable data
    [36] - Tmax not calculated because there was an insufficient number of participants with evaluable data
    No statistical analyses for this end point

    Secondary: Trough Observed Plasma Concentration (Ctrough)

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    End point title
    Trough Observed Plasma Concentration (Ctrough)
    End point description
    Ctrough is defined as the concentration reached by a drug immediately before the next dose is administered "99999"=N/A
    End point type
    Secondary
    End point timeframe
    From first dose up to prespecified timepoints, C0D1, C5D1, C0D1, C1D15, C5D1
    End point values
    Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO Part 1-Arm C-Chort 2: 2/3L CRC MSS/BMS600QD + NIVO Part 1-Arm C-Chort 3: 2/3L CRC MSS/BMS300QD + NIVO Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
    Number of subjects analysed
    6
    3
    4
    4
    5
    1
    2
    2
    1
    2
    11
    16
    3
    7
    6
    0 [37]
    1
    1
    Units: ng/mL
    arithmetic mean (standard deviation)
        C0D1 - BMS-813160
    283.70 ( 207.784 )
    84.30 ( 46.169 )
    292.0 ( 154.31 )
    74.05 ( 72.127 )
    157.28 ( 92.311 )
    137.0 ( 99999 )
    57.10 ( 54.871 )
    5.485 ( 2.4395 )
    77.40 ( 99999 )
    154.05 ( 139.936 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    99999 ( 99999 )
    99999 ( 99999 )
        C5D1 - BMS-813160
    268.80 ( 216.882 )
    129.40 ( 89.944 )
    176.0 ( 99999 )
    15.30 ( 99999 )
    323.0 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    99999 ( 99999 )
    99999 ( 99999 )
        C0D1 - BMS-939429
    172.63 ( 264.187 )
    31.40 ( 10.689 )
    180.88 ( 195.959 )
    72.95 ( 55.542 )
    47.60 ( 10.412 )
    31.50 ( 99999 )
    63.45 ( 60.175 )
    4.950 ( 2.3052 )
    90.30 ( 99999 )
    71.65 ( 55.649 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    99999 ( 99999 )
    99999 ( 99999 )
        C1D15 - BMS 939429
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    191.33 ( 84.266 )
    24.106 ( 18.445 )
    275.7 ( 164.34 )
    116.04 ( 29.696 )
    145.00 ( 99.293 )
    ( )
    283.0 ( 99999 )
    99999 ( 99999 )
        C5D1 - BMS-939429
    55.78 ( 31.877 )
    15.95 ( 4.172 )
    155.0 ( 99999 )
    10.50 ( 99999 )
    65.20 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    186.21 ( 131.457 )
    12.439 ( 6.9685 )
    195.0 ( 99999 )
    191.44 ( 113.725 )
    222.65 ( 154.316 )
    ( )
    99999 ( 99999 )
    390.0 ( 99999 )
    Notes
    [37] - Ctrough not calculated because there was an insufficient number of participants with evaluable data
    No statistical analyses for this end point

    Secondary: Area Under Curve (AUC) 0-8

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    End point title
    Area Under Curve (AUC) 0-8
    End point description
    Area Under Curve (AUC) is defined as the area under the plot of plasma concentration of a drug versus time after dosage measured at 8 hours post-dose "99999"=N/A
    End point type
    Secondary
    End point timeframe
    From first dose up to prespecified timepoints- C0D1, C2D1
    End point values
    Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO Part 1-Arm C-Chort 2: 2/3L CRC MSS/BMS600QD + NIVO Part 1-Arm C-Chort 3: 2/3L CRC MSS/BMS300QD + NIVO Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
    Number of subjects analysed
    10
    7
    10
    10
    8
    7
    7
    6
    1
    1
    9
    13
    0 [38]
    14
    0 [39]
    0 [40]
    1
    0 [41]
    Units: ug*h/mL
    arithmetic mean (standard deviation)
        C0D1 - BMS-813160
    2300.018 ( 976.4608 )
    7069.265 ( 2452.4213 )
    2725.390 ( 1365.3562 )
    7884.381 ( 3968.4940 )
    1534.932 ( 518.2172 )
    6593.904 ( 3603.5286 )
    3533.737 ( 1931.7752 )
    878.051 ( 535.3197 )
    4440.313 ( 99999 )
    3656.713 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    99999 ( 99999 )
    ( )
        C0D1 - BMS-939429
    652.848 ( 363.5925 )
    1783.336 ( 856.0103 )
    936.394 ( 826.5807 )
    2302.092 ( 1023.3978 )
    342.534 ( 157.1350 )
    2147.888 ( 1415.6386 )
    942.398 ( 620.1018 )
    210.938 ( 106.5352 )
    1919.228 ( 99999 )
    411.410 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    99999 ( 99999 )
    ( )
        C2D1 - BMS-813160
    5348.973 ( 2506.2558 )
    11967.560 ( 4586.3823 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    4838.264 ( 2750.7756 )
    1483.423 ( 1236.0374 )
    ( )
    3821.887 ( 2221.2474 )
    ( )
    ( )
    99999 ( 99999 )
    ( )
        C2D1 - BMS-939429
    1410.415 ( 837.4895 )
    2403.182 ( 1144.3271 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    99999 ( 99999 )
    ( )
    Notes
    [38] - AUC not calculated because there was an insufficient number of participants with evaluable data
    [39] - AUC not calculated because there was an insufficient number of participants with evaluable data
    [40] - AUC not calculated because there was an insufficient number of participants with evaluable data
    [41] - AUC not calculated because there was an insufficient number of participants with evaluable data
    No statistical analyses for this end point

    Secondary: Area Under Curve (AUC) 0-24

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    End point title
    Area Under Curve (AUC) 0-24
    End point description
    Area Under Curve (AUC) is defined as the area under the plot of plasma concentration of a drug versus time after dosage measured at 8 hours post-dose
    End point type
    Secondary
    End point timeframe
    From first dose up to prespecified timepoints-C0D1, C2D1
    End point values
    Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO Part 1-Arm C-Chort 2: 2/3L CRC MSS/BMS600QD + NIVO Part 1-Arm C-Chort 3: 2/3L CRC MSS/BMS300QD + NIVO Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
    Number of subjects analysed
    0 [42]
    7
    0 [43]
    9
    0 [44]
    5
    7
    6
    0 [45]
    1
    0 [46]
    11
    0 [47]
    0 [48]
    0 [49]
    0 [50]
    0 [51]
    0 [52]
    Units: ug*h/mL
    arithmetic mean (standard deviation)
        C0D1 - BMS-813160
    ( )
    9383.385 ( 2842.8397 )
    ( )
    11726.669 ( 6439.1376 )
    ( )
    10447.179 ( 2995.9347 )
    4829.881 ( 2696.4668 )
    1275.314 ( 799.8262 )
    ( )
    7687.658 ( 99999 )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
        C0D1 - BMS-939429
    ( )
    2638.062 ( 977.2502 )
    ( )
    3991.522 ( 1636.3573 )
    ( )
    3905.941 ( 1852.8415 )
    1660.159 ( 991.0121 )
    341.0396 ( 160.4425 )
    ( )
    940.294 ( 99999 )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
        C2D1 - BMS-813160
    ( )
    17890.458 ( 9212.5646 )
    ( )
    99999 ( 99999 )
    ( )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    99999 ( 99999 )
    ( )
    2050.804 ( 997.6990 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
        C2D1 - BMS-939429
    ( )
    3958.779 ( 1632.3781 )
    ( )
    99999 ( 99999 )
    ( )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    99999 ( 99999 )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Notes
    [42] - AUC not calculated because there was an insufficient number of participants with evaluable data
    [43] - AUC not calculated because there was an insufficient number of participants with evaluable data
    [44] - AUC not calculated because there was an insufficient number of participants with evaluable data
    [45] - AUC not calculated because there was an insufficient number of participants with evaluable data
    [46] - AUC not calculated because there was an insufficient number of participants with evaluable data
    [47] - AUC not calculated because there was an insufficient number of participants with evaluable data
    [48] - AUC not calculated because there was an insufficient number of participants with evaluable data
    [49] - AUC not calculated because there was an insufficient number of participants with evaluable data
    [50] - AUC not calculated because there was an insufficient number of participants with evaluable data
    [51] - AUC not calculated because there was an insufficient number of participants with evaluable data
    [52] - AUC not calculated because there was an insufficient number of participants with evaluable data
    No statistical analyses for this end point

    Secondary: Apparent Total Body Clearance (CLT/F)

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    End point title
    Apparent Total Body Clearance (CLT/F)
    End point description
    The total body clearance (CLT/F) is defined as the volume of plasma completely cleared of drug per unit time. "99999"=N/A
    End point type
    Secondary
    End point timeframe
    From first dose up to prespecified timepoints-C0D1, C2D14
    End point values
    Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO Part 1-Arm C-Chort 2: 2/3L CRC MSS/BMS600QD + NIVO Part 1-Arm C-Chort 3: 2/3L CRC MSS/BMS300QD + NIVO Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
    Number of subjects analysed
    8
    5
    7
    4
    6
    2
    3
    2
    1
    2
    9
    13
    0 [53]
    10
    0 [54]
    0 [55]
    0 [56]
    0 [57]
    Units: mL/min
    arithmetic mean (standard deviation)
        C0D14 - BMS-813160
    1163.173 ( 588.1385 )
    744.746 ( 361.5390 )
    1521.863 ( 1277.8075 )
    826.468 ( 300.1738 )
    1602.009 ( 1123.8919 )
    961.379 ( 235.4622 )
    1688.813 ( 1022.7160 )
    4950.110 ( 781.0155 )
    1135.947 ( 99999 )
    1032.434 ( 850.2203 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    ( )
        C2D1 - BMS-813160
    956.446 ( 596.7553 )
    683.958 ( 322.7045 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    99999 ( 99999 )
    1115.087 ( 851.2513 )
    1813.987 ( 1920.2627 )
    ( )
    1440.516 ( 733.5156 )
    ( )
    ( )
    ( )
    ( )
    Notes
    [53] - CLT/F not calculated because there was an insufficient number of participants with evaluable data
    [54] - CLT/F not calculated because there was an insufficient number of participants with evaluable data
    [55] - CLT/F not calculated because there was an insufficient number of participants with evaluable data
    [56] - CLT/F not calculated because there was an insufficient number of participants with evaluable data
    [57] - CLT/F not calculated because there was an insufficient number of participants with evaluable data
    No statistical analyses for this end point

    Secondary: Renal Clearance (CLR)

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    End point title
    Renal Clearance (CLR)
    End point description
    Renal clearance is defined as the rate at which the analytes were removed from the plasma by the kidneys.
    End point type
    Secondary
    End point timeframe
    From first dose up to prespecified timepoints-C0D1, C0D14
    End point values
    Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO Part 1-Arm C-Chort 2: 2/3L CRC MSS/BMS600QD + NIVO Part 1-Arm C-Chort 3: 2/3L CRC MSS/BMS300QD + NIVO Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
    Number of subjects analysed
    7
    4
    6
    3
    7
    3
    5
    4
    0 [58]
    1
    0 [59]
    0 [60]
    0 [61]
    0 [62]
    0 [63]
    0 [64]
    0 [65]
    0 [66]
    Units: mL/min
    arithmetic mean (standard deviation)
        C0D1 - BMS-813160
    212.411 ( 191.8961 )
    275.309 ( 277.2659 )
    139.012 ( 107.2006 )
    165.327 ( 77.8766 )
    155.820 ( 119.3858 )
    181.930 ( 9.1130 )
    248.003 ( 82.6974 )
    236.781 ( 62.8689 )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
        C0D1 - BMS-939429
    74.298 ( 44.8889 )
    175.109 ( 187.5683 )
    68.184 ( 52.1580 )
    77.744 ( 34.8177 )
    81.027 ( 65.1050 )
    98.733 ( 6.2562 )
    140.597 ( 41.7347 )
    128.943 ( 26.7782 )
    ( )
    62.007 ( 99999 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
        C0D14 - BMS-813160
    185.926 ( 56.5866 )
    124.400 ( 52.1454 )
    260.786 ( 120.8954 )
    168.274 ( 72.7581 )
    158.238 ( 82.5905 )
    194.009 ( 50.1111 )
    283.842 ( 109.4518 )
    149.271 ( 72.0204 )
    ( )
    115.147 ( 99999 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
        C0D14 - BMS-939429
    101.042 ( 27.5043 )
    76.285 ( 30.5071 )
    145.662 ( 73.3215 )
    91.490 ( 43.8006 )
    87.068 ( 43.9667 )
    111.649 ( 32.4552 )
    99999 ( 99999 )
    99999 ( 99999 )
    ( )
    99999 ( 99999 )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Notes
    [58] - CLR not calculated because there was an insufficient number of participants with evaluable data
    [59] - CLR not calculated because there was an insufficient number of participants with evaluable data
    [60] - CLR not calculated because there was an insufficient number of participants with evaluable data
    [61] - CLR not calculated because there was an insufficient number of participants with evaluable data
    [62] - CLR not calculated because there was an insufficient number of participants with evaluable data
    [63] - CLR not calculated because there was an insufficient number of participants with evaluable data
    [64] - CLR not calculated because there was an insufficient number of participants with evaluable data
    [65] - CLR not calculated because there was an insufficient number of participants with evaluable data
    [66] - CLR not calculated because there was an insufficient number of participants with evaluable data
    No statistical analyses for this end point

    Secondary: Number of Participants who were Anti-Drug Antibody (ADA) Positive

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    End point title
    Number of Participants who were Anti-Drug Antibody (ADA) Positive
    End point description
    The number of participants who are anti-drug antibody positive. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment. ADA-positive sample is in a participant who is baseline ADA negative or with an ADA titer to be at least 4-fold or greater than baseline positive titer.
    End point type
    Secondary
    End point timeframe
    From first dose up to prespecified timepoints-C1D1, C1D15, C2D1, C3D1, C5D1, C9D1
    End point values
    Part 1-Arm A-Cohort 1: 1L CRC/BMS300BID + FOLFIRI Part 1-Arm A-Cohort 2: 1L CRC/BMS600QD + FOLFIRI Part 1-Arm B-Cohort 1: 1L PC/BMS300BID + GEM/NAB Part 1-Arm B-Cohort 2: 1L PC/BMS600QD + GEM/NAB Part 1-Arm C-Cohort 1: 2/3L CRC MSS/BMS300BID + NIVO Part 1-Arm C-Chort 2: 2/3L CRC MSS/BMS600QD + NIVO Part 1-Arm C-Chort 3: 2/3L CRC MSS/BMS300QD + NIVO Part 1-Arm C-Cohort 4: 2/3L CRC MSS/BMS150QD + NIVO Part 1-Arm C-Cohort 5: 2L PC/BMS300BID + NIVO Part 1-Arm C-Cohort 6: 2L PC/BMS600QD + NIVO Part 2-Arm A-Cohort 1a: 2L CRC/BMS300BID + FOLFIRI Part 2-Arm A-Cohort 1b: 2L CRC/BMS150QD + FOLFIRI Part 2-Arm A-Cohort 1C: 2L CRC/FOLFIRI Part 2-Arm B-Cohort 3a: 1L PC/BMS300BID + GEM/NAB Part 2-Arm B-Cohort 3b: 1L PC/BMS300BID + GEM/NAB + NIVO Part 2-Arm B-Cohort 3C: 1L PC/GEM/NAB Part 2-Arm C-Cohort 4: 2L PC/BMS300BID + NIVO Part 2-Arm C-Cohort 5: 2/3L CRC MSS /BMS300BID + NIVO
    Number of subjects analysed
    10
    8
    10
    11
    8
    7
    7
    11
    1
    2
    32
    32
    26
    35
    35
    32
    24
    33
    Units: Participants
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Participants were assessed for all-cause mortality from their randomization to study completion, (up to approximately 5.5 years). SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 3 years).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    P1 1L CRC/BMS300BID + FOLFIRI
    Reporting group description
    First-line treatment BMS-813160 300 mg twice a day in combination with FOLFIRI in participants with metastatic colorectal cancer

    Reporting group title
    P1 1L PC/BMS600QD + GEM/NAB
    Reporting group description
    First-line treatment BMS-813160 600 mg once a day in combination with Gem/ nab-paclitaxel (ABRAXANE)

    Reporting group title
    P1 1L PC/BMS300BID + GEM/NAB
    Reporting group description
    First-line treatment BMS-813160 300 mg twice a day in combination with Gem/nab-paclitaxel (ABRAXANE) in participants with pancreatic cancer

    Reporting group title
    P1 1L CRC/BMS600QD + FOLFIRI
    Reporting group description
    First-line treatment BMS-813160 600 mg once a day in combination with FOLFIRI in participants with metastatic colorectal cancer

    Reporting group title
    P1 2L PC/BMS300BID + NIVO
    Reporting group description
    Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer

    Reporting group title
    P1 2/3L CRC MSS/BMS150QD + NIVO
    Reporting group description
    Second- and third-line treatment BMS-813160 150mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer

    Reporting group title
    P1 2/3L CRC MSS/BMS300QD + NIVO
    Reporting group description
    Second- and third-line treatment BMS-813160 300mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer

    Reporting group title
    P1 2/3L CRC MSS/BMS600QD + NIVO
    Reporting group description
    Second- and third-line treatment BMS-813160 600mg once a day in combination with nivolumab in participants with microsatellite stable colorectal cancer

    Reporting group title
    P1 2/3L CRC MSS/BMS300BID + NIVO
    Reporting group description
    Second- and third-line treatment BMS-813160 300mg twice a day in combination with nivolumab in participants with microsatellite stable colorectal cancer

    Reporting group title
    P1 2L PC/BMS600QD + NIVO
    Reporting group description
    Second-line treatment BMS-813160 600mg once per day in combination with nivolumab in participants with pancreatic cancer

    Reporting group title
    P2 1L PC/BMS300BID + GEM/NAB + NIVO
    Reporting group description
    First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel and nivolumab in participants with pancreatic cancer

    Reporting group title
    P2 1L PC/BMS300BID + GEM/NAB
    Reporting group description
    First-line treatment BMS-813160 300mg twice per day in combination with gemcitabine/nab-paclitaxel in participants with pancreatic cancer

    Reporting group title
    P2 2L CRC/FOLFIRI
    Reporting group description
    Second-line treatment FOLFIRI in participants with colorectal cancer

    Reporting group title
    P2 2L CRC/BMS300BID + FOLFIRI
    Reporting group description
    Second-line treatment BMS-813160 300mg twice per day in combination with FOLFIRI in participants with colorectal cancer

    Reporting group title
    P2 2L CRC/BMS150QD + FOLFIRI
    Reporting group description
    Second-line treatment BMS-813160 150mg once per day in combination with FOLFIRI in participants with colorectal cancer

    Reporting group title
    P2 1L PC/GEM/NAB
    Reporting group description
    First-line treatment gemcitabine/ nab-paclitaxel in participants with pancreatic cancer

    Reporting group title
    P2 2/3L CRC MSS /BMS300BID + NIVO
    Reporting group description
    Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer

    Reporting group title
    P2 2L PC/BMS300BID + NIVO
    Reporting group description
    Second-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with pancreatic cancer

    Reporting group title
    P2 2L CRC /FOLFIRI P2 2/3L CRC MSS/BMS300BID + NIVO
    Reporting group description
    Second- and third-line treatment BMS-813160 300mg twice per day in combination with nivolumab in participants with microsatellite stable colorectal cancer

    Serious adverse events
    P1 1L CRC/BMS300BID + FOLFIRI P1 1L PC/BMS600QD + GEM/NAB P1 1L PC/BMS300BID + GEM/NAB P1 1L CRC/BMS600QD + FOLFIRI P1 2L PC/BMS300BID + NIVO P1 2/3L CRC MSS/BMS150QD + NIVO P1 2/3L CRC MSS/BMS300QD + NIVO P1 2/3L CRC MSS/BMS600QD + NIVO P1 2/3L CRC MSS/BMS300BID + NIVO P1 2L PC/BMS600QD + NIVO P2 1L PC/BMS300BID + GEM/NAB + NIVO P2 1L PC/BMS300BID + GEM/NAB P2 2L CRC/FOLFIRI P2 2L CRC/BMS300BID + FOLFIRI P2 2L CRC/BMS150QD + FOLFIRI P2 1L PC/GEM/NAB P2 2/3L CRC MSS /BMS300BID + NIVO P2 2L PC/BMS300BID + NIVO P2 2L CRC /FOLFIRI P2 2/3L CRC MSS/BMS300BID + NIVO
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 10 (50.00%)
    7 / 11 (63.64%)
    5 / 10 (50.00%)
    5 / 8 (62.50%)
    1 / 1 (100.00%)
    6 / 11 (54.55%)
    6 / 7 (85.71%)
    6 / 7 (85.71%)
    5 / 8 (62.50%)
    2 / 2 (100.00%)
    22 / 35 (62.86%)
    24 / 35 (68.57%)
    4 / 17 (23.53%)
    12 / 32 (37.50%)
    12 / 32 (37.50%)
    15 / 32 (46.88%)
    14 / 24 (58.33%)
    17 / 24 (70.83%)
    5 / 9 (55.56%)
         number of deaths (all causes)
    6
    8
    8
    6
    1
    7
    6
    6
    6
    2
    34
    33
    10
    26
    28
    26
    18
    20
    7
         number of deaths resulting from adverse events
    0
    1
    1
    0
    1
    4
    5
    4
    1
    2
    4
    3
    0
    0
    1
    3
    5
    8
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Histiocytic necrotising lymphadenitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Malignant neoplasm progression
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 1 (100.00%)
    4 / 11 (36.36%)
    5 / 7 (71.43%)
    3 / 7 (42.86%)
    0 / 8 (0.00%)
    2 / 2 (100.00%)
    2 / 35 (5.71%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    5 / 24 (20.83%)
    7 / 24 (29.17%)
    3 / 9 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 4
    0 / 5
    0 / 3
    0 / 0
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 5
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    4 / 4
    5 / 5
    3 / 3
    0 / 0
    2 / 2
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    5 / 5
    7 / 7
    1 / 1
    Metastases to central nervous system
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    Squamous cell carcinoma of skin
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    1 / 2 (50.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    2 / 24 (8.33%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    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
    Embolism
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally 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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    2 / 35 (5.71%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gait disturbance
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Fatigue
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    3 / 24 (12.50%)
    0 / 9 (0.00%)
         occurrences causally 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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 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
    General physical health deterioration
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    1 / 2 (50.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza like illness
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    Pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral swelling
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 11 (18.18%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    5 / 35 (14.29%)
    4 / 35 (11.43%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    2 / 32 (6.25%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    3 / 4
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    5 / 10
    3 / 5
    0 / 0
    0 / 0
    0 / 0
    1 / 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
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    Reproductive system and breast disorders
    Balanoposthitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostatic haemorrhage
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    Cough
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 10 (0.00%)
    0 / 11 (0.00%)
    2 / 10 (20.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    2 / 35 (5.71%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    Hypoxia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (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 / 1
    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
    Pleural effusion
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    Pleuritic pain
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    Pulmonary embolism
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    3 / 24 (12.50%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 1 (100.00%)
    1 / 11 (9.09%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally 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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Streptococcus test positive
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    White blood cell count increased
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Fall
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related 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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural bile leak
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Post procedural complication
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 compression fracture
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    Transfusion reaction
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Wrong product administered
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related 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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    Atrial flutter
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    Cardiac arrest
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related 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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stress cardiomyopathy
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    Nervous system disorders
    Altered state of consciousness
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    2 / 32 (6.25%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    2 / 24 (8.33%)
    0 / 9 (0.00%)
         occurrences causally related 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 / 3
    0 / 1
    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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Hepatic encephalopathy
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intracranial mass
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Seizure
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    1 / 10 (10.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    2 / 35 (5.71%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    1 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    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
    Febrile neutropenia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    2 / 35 (5.71%)
    2 / 35 (5.71%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (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
    2 / 2
    2 / 2
    0 / 0
    1 / 1
    0 / 1
    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
    Neutropenia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    3 / 35 (8.57%)
    2 / 35 (5.71%)
    0 / 17 (0.00%)
    3 / 32 (9.38%)
    0 / 32 (0.00%)
    2 / 32 (6.25%)
    2 / 24 (8.33%)
    3 / 24 (12.50%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 2
    0 / 0
    0 / 4
    0 / 0
    0 / 2
    0 / 2
    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 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    Abdominal pain upper
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal haemorrhage
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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 / 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
    Diarrhoea
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    3 / 35 (8.57%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 3
    1 / 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
    Constipation
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal stenosis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related 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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    2 / 24 (8.33%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (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 / 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
    Large intestinal obstruction
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 9 (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 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant gastrointestinal obstruction
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Nausea
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 11 (18.18%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    2 / 35 (5.71%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    3 / 24 (12.50%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 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
    Oesophagitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Proctalgia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    3 / 32 (9.38%)
    2 / 32 (6.25%)
    1 / 32 (3.13%)
    2 / 24 (8.33%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 6
    0 / 3
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    2 / 35 (5.71%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
    2 / 24 (8.33%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    Hepatobiliary disorders
    Autoimmune hepatitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences causally 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
    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
    Cholangitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    2 / 35 (5.71%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    1 / 24 (4.17%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    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
    Biliary obstruction
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    1 / 24 (4.17%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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 / 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
    Hepatitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally 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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Portal hypertension
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Skin and subcutaneous tissue disorders
    Panniculitis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 11 (18.18%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rash maculo-papular
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    2 / 35 (5.71%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related 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
    1 / 2
    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
    Haematuria
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         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 / 1
    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
    Flank pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related 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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    Bacteraemia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    2 / 35 (5.71%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 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
    Biliary tract infection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    COVID-19
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis viral
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related 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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    Cholangitis infective
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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 / 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
    Escherichia bacteraemia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (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 / 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
    Clostridium difficile infection
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (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 / 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
    Fournier's gangrene
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis sapovirus
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    Hepatic infection
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    2 / 35 (5.71%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (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
    1 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related 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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Klebsiella bacteraemia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphangitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    1 / 17 (5.88%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    3 / 32 (9.38%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis bacterial
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         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 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    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
         deaths causally related to treatment / all
    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
    Rectal abscess
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Respiratory tract infection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related 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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Scrotal abscess
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Sepsis
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 11 (18.18%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    2 / 35 (5.71%)
    5 / 35 (14.29%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    2 / 5
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Splenic infection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    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
    Spontaneous bacterial peritonitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (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 / 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
    Suspected COVID-19
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related 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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Decreased appetite
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Dehydration
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (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
    1 / 1
    1 / 1
    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
    Failure to thrive
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Hypernatraemia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (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 / 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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    P1 1L CRC/BMS300BID + FOLFIRI P1 1L PC/BMS600QD + GEM/NAB P1 1L PC/BMS300BID + GEM/NAB P1 1L CRC/BMS600QD + FOLFIRI P1 2L PC/BMS300BID + NIVO P1 2/3L CRC MSS/BMS150QD + NIVO P1 2/3L CRC MSS/BMS300QD + NIVO P1 2/3L CRC MSS/BMS600QD + NIVO P1 2/3L CRC MSS/BMS300BID + NIVO P1 2L PC/BMS600QD + NIVO P2 1L PC/BMS300BID + GEM/NAB + NIVO P2 1L PC/BMS300BID + GEM/NAB P2 2L CRC/FOLFIRI P2 2L CRC/BMS300BID + FOLFIRI P2 2L CRC/BMS150QD + FOLFIRI P2 1L PC/GEM/NAB P2 2/3L CRC MSS /BMS300BID + NIVO P2 2L PC/BMS300BID + NIVO P2 2L CRC /FOLFIRI P2 2/3L CRC MSS/BMS300BID + NIVO
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 10 (100.00%)
    11 / 11 (100.00%)
    9 / 10 (90.00%)
    8 / 8 (100.00%)
    1 / 1 (100.00%)
    10 / 11 (90.91%)
    7 / 7 (100.00%)
    7 / 7 (100.00%)
    8 / 8 (100.00%)
    2 / 2 (100.00%)
    34 / 35 (97.14%)
    35 / 35 (100.00%)
    16 / 17 (94.12%)
    32 / 32 (100.00%)
    31 / 32 (96.88%)
    31 / 32 (96.88%)
    22 / 24 (91.67%)
    19 / 24 (79.17%)
    9 / 9 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour pain
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    3 / 35 (8.57%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    2 / 32 (6.25%)
    1 / 32 (3.13%)
    2 / 32 (6.25%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    1
    0
    0
    1
    0
    3
    1
    0
    2
    1
    2
    0
    0
    0
    Embolism
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    2 / 35 (5.71%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    Flushing
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    1
    1
    0
    0
    0
    Hot flush
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    Hypertension
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    2 / 7 (28.57%)
    1 / 7 (14.29%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    3 / 35 (8.57%)
    4 / 35 (11.43%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    2 / 32 (6.25%)
    4 / 32 (12.50%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    2
    1
    1
    0
    4
    6
    0
    1
    2
    6
    0
    0
    2
    Hypotension
         subjects affected / exposed
    1 / 10 (10.00%)
    3 / 11 (27.27%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    3 / 35 (8.57%)
    4 / 35 (11.43%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    4 / 32 (12.50%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    0
    0
    1
    0
    3
    7
    0
    0
    1
    4
    0
    1
    0
    Lymphorrhoea
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Superficial vein thrombosis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Venous thrombosis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    3 / 35 (8.57%)
    5 / 35 (14.29%)
    3 / 17 (17.65%)
    4 / 32 (12.50%)
    3 / 32 (9.38%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    13
    6
    18
    19
    12
    1
    0
    1
    0
    Chest discomfort
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Fatigue
         subjects affected / exposed
    6 / 10 (60.00%)
    5 / 11 (45.45%)
    7 / 10 (70.00%)
    4 / 8 (50.00%)
    0 / 1 (0.00%)
    4 / 11 (36.36%)
    3 / 7 (42.86%)
    3 / 7 (42.86%)
    5 / 8 (62.50%)
    1 / 2 (50.00%)
    27 / 35 (77.14%)
    23 / 35 (65.71%)
    10 / 17 (58.82%)
    13 / 32 (40.63%)
    11 / 32 (34.38%)
    19 / 32 (59.38%)
    8 / 24 (33.33%)
    10 / 24 (41.67%)
    5 / 9 (55.56%)
         occurrences all number
    22
    7
    9
    4
    0
    4
    3
    3
    5
    1
    30
    34
    12
    15
    18
    24
    9
    10
    8
    Cyst
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Chills
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    5 / 35 (14.29%)
    6 / 35 (17.14%)
    1 / 17 (5.88%)
    3 / 32 (9.38%)
    1 / 32 (3.13%)
    3 / 32 (9.38%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    1 / 9 (11.11%)
         occurrences all number
    1
    3
    0
    1
    0
    0
    0
    0
    0
    0
    6
    9
    1
    4
    1
    3
    0
    1
    1
    Chest pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    Localised oedema
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    1
    Influenza like illness
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    2 / 35 (5.71%)
    1 / 35 (2.86%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    2
    1
    1
    0
    1
    0
    0
    0
    0
    Generalised oedema
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    1
    Malaise
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    2 / 35 (5.71%)
    2 / 35 (5.71%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    2
    0
    0
    0
    0
    0
    2
    0
    Gait disturbance
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    2 / 35 (5.71%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    2 / 24 (8.33%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    2
    0
    0
    0
    0
    0
    2
    0
    Oedema peripheral
         subjects affected / exposed
    2 / 10 (20.00%)
    5 / 11 (45.45%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    1 / 2 (50.00%)
    12 / 35 (34.29%)
    15 / 35 (42.86%)
    1 / 17 (5.88%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    11 / 32 (34.38%)
    1 / 24 (4.17%)
    2 / 24 (8.33%)
    3 / 9 (33.33%)
         occurrences all number
    2
    7
    1
    0
    0
    1
    1
    1
    0
    1
    12
    17
    1
    1
    1
    11
    1
    2
    4
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 1 (100.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    2 / 35 (5.71%)
    2 / 35 (5.71%)
    0 / 17 (0.00%)
    3 / 32 (9.38%)
    2 / 32 (6.25%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    2
    3
    0
    3
    2
    0
    1
    1
    0
    Mucosal inflammation
         subjects affected / exposed
    2 / 10 (20.00%)
    2 / 11 (18.18%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    3 / 35 (8.57%)
    1 / 35 (2.86%)
    4 / 17 (23.53%)
    2 / 32 (6.25%)
    5 / 32 (15.63%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    4
    2
    0
    1
    0
    0
    0
    0
    1
    0
    3
    1
    4
    3
    10
    0
    0
    0
    0
    Pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    2 / 8 (25.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    2 / 32 (6.25%)
    1 / 32 (3.13%)
    1 / 24 (4.17%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    1
    0
    2
    2
    1
    1
    2
    0
    Peripheral swelling
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 1 (100.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    2 / 35 (5.71%)
    5 / 35 (14.29%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    2 / 32 (6.25%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    5
    0
    0
    0
    2
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 11 (18.18%)
    1 / 10 (10.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    3 / 11 (27.27%)
    2 / 7 (28.57%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    15 / 35 (42.86%)
    11 / 35 (31.43%)
    1 / 17 (5.88%)
    5 / 32 (15.63%)
    4 / 32 (12.50%)
    10 / 32 (31.25%)
    4 / 24 (16.67%)
    5 / 24 (20.83%)
    2 / 9 (22.22%)
         occurrences all number
    0
    5
    1
    1
    0
    3
    2
    0
    1
    0
    49
    24
    1
    5
    4
    13
    6
    6
    2
    Swelling
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Temperature intolerance
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    2 / 35 (5.71%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    2 / 32 (6.25%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    Perineal pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pelvic pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    1
    0
    0
    0
    Breast pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Scrotal pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Aspiration
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Atelectasis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dyspnoea
         subjects affected / exposed
    2 / 10 (20.00%)
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    1 / 1 (100.00%)
    0 / 11 (0.00%)
    3 / 7 (42.86%)
    0 / 7 (0.00%)
    3 / 8 (37.50%)
    0 / 2 (0.00%)
    9 / 35 (25.71%)
    10 / 35 (28.57%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    6 / 32 (18.75%)
    1 / 24 (4.17%)
    3 / 24 (12.50%)
    3 / 9 (33.33%)
         occurrences all number
    2
    2
    2
    0
    1
    0
    3
    0
    3
    0
    9
    13
    0
    1
    0
    7
    1
    3
    3
    Dyspnoea exertional
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    1 / 2 (50.00%)
    0 / 35 (0.00%)
    2 / 35 (5.71%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    3
    1
    0
    0
    0
    1
    3
    0
    Epistaxis
         subjects affected / exposed
    2 / 10 (20.00%)
    1 / 11 (9.09%)
    2 / 10 (20.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    4 / 35 (11.43%)
    4 / 35 (11.43%)
    3 / 17 (17.65%)
    4 / 32 (12.50%)
    7 / 32 (21.88%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    2
    1
    2
    1
    0
    0
    0
    0
    0
    0
    4
    5
    3
    4
    8
    0
    0
    0
    1
    Cough
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 11 (18.18%)
    2 / 10 (20.00%)
    2 / 8 (25.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    1 / 7 (14.29%)
    2 / 7 (28.57%)
    2 / 8 (25.00%)
    0 / 2 (0.00%)
    11 / 35 (31.43%)
    11 / 35 (31.43%)
    1 / 17 (5.88%)
    3 / 32 (9.38%)
    4 / 32 (12.50%)
    3 / 32 (9.38%)
    4 / 24 (16.67%)
    1 / 24 (4.17%)
    3 / 9 (33.33%)
         occurrences all number
    0
    2
    3
    3
    0
    1
    1
    2
    2
    0
    13
    15
    1
    5
    4
    3
    4
    1
    3
    Dysphonia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    2 / 35 (5.71%)
    2 / 35 (5.71%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    1
    0
    2
    2
    0
    0
    0
    0
    0
    1
    0
    Hiccups
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    2 / 17 (11.76%)
    3 / 32 (9.38%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    2
    3
    0
    2
    0
    0
    0
    Haemoptysis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    Nasal congestion
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 11 (18.18%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    2 / 35 (5.71%)
    3 / 35 (8.57%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    3 / 32 (9.38%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    0
    0
    0
    0
    0
    2
    3
    0
    0
    1
    3
    0
    0
    0
    Nasal inflammation
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    2 / 17 (11.76%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    4
    1
    0
    0
    0
    0
    0
    Pleural effusion
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 11 (18.18%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    1
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    2 / 35 (5.71%)
    1 / 17 (5.88%)
    1 / 32 (3.13%)
    2 / 32 (6.25%)
    3 / 32 (9.38%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    1
    1
    2
    3
    0
    0
    0
    Pleuritic pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Productive cough
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    2 / 11 (18.18%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    2 / 35 (5.71%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    2
    0
    0
    0
    1
    1
    0
    0
    Pneumonitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    2
    1
    0
    0
    0
    0
    0
    0
    0
    Pulmonary embolism
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 1 (100.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    3 / 35 (8.57%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    3
    1
    0
    0
    1
    1
    1
    0
    1
    Respiratory tract congestion
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Respiratory failure
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    1 / 32 (3.13%)
    2 / 32 (6.25%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    2
    0
    0
    0
    0
    Wheezing
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Upper-airway cough syndrome
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    4 / 35 (11.43%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    0
    1
    0
    0
    0
    0
    0
    0
    4
    1
    0
    1
    1
    1
    2
    0
    0
    Sinus congestion
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    3 / 35 (8.57%)
    3 / 35 (8.57%)
    1 / 17 (5.88%)
    2 / 32 (6.25%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    4 / 24 (16.67%)
    1 / 24 (4.17%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    3
    3
    1
    2
    1
    0
    4
    1
    1
    Adjustment disorder with depressed mood
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Confusional state
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    2 / 24 (8.33%)
    0 / 9 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    2
    0
    Delirium
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Delusion
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Depression
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    4 / 35 (11.43%)
    2 / 35 (5.71%)
    0 / 17 (0.00%)
    2 / 32 (6.25%)
    0 / 32 (0.00%)
    3 / 32 (9.38%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    1
    0
    0
    1
    0
    4
    2
    0
    2
    0
    3
    1
    0
    0
    Insomnia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    3 / 10 (30.00%)
    4 / 8 (50.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    4 / 35 (11.43%)
    1 / 17 (5.88%)
    4 / 32 (12.50%)
    5 / 32 (15.63%)
    1 / 32 (3.13%)
    2 / 24 (8.33%)
    3 / 24 (12.50%)
    4 / 9 (44.44%)
         occurrences all number
    0
    0
    3
    4
    0
    0
    0
    1
    0
    0
    1
    4
    2
    4
    6
    1
    2
    3
    5
    Sleep disorder
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    0
    0
    0
    0
    0
    Irritability
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    2 / 35 (5.71%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    0
    0
    0
    0
    0
    0
    0
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    2 / 35 (5.71%)
    4 / 35 (11.43%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    2 / 24 (8.33%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    5
    0
    0
    0
    0
    0
    2
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 10 (0.00%)
    4 / 11 (36.36%)
    3 / 10 (30.00%)
    2 / 8 (25.00%)
    0 / 1 (0.00%)
    2 / 11 (18.18%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    2 / 8 (25.00%)
    0 / 2 (0.00%)
    10 / 35 (28.57%)
    10 / 35 (28.57%)
    0 / 17 (0.00%)
    3 / 32 (9.38%)
    0 / 32 (0.00%)
    10 / 32 (31.25%)
    2 / 24 (8.33%)
    3 / 24 (12.50%)
    1 / 9 (11.11%)
         occurrences all number
    0
    5
    6
    3
    0
    2
    0
    0
    2
    0
    16
    23
    0
    3
    0
    14
    2
    3
    1
    Amylase increased
         subjects affected / exposed
    2 / 10 (20.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    1 / 1 (100.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    3 / 35 (8.57%)
    1 / 17 (5.88%)
    2 / 32 (6.25%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    3
    1
    0
    2
    1
    1
    0
    0
    1
    0
    1
    6
    1
    3
    0
    1
    1
    0
    2
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    Blood bilirubin increased
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 11 (18.18%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    2 / 35 (5.71%)
    5 / 35 (14.29%)
    0 / 17 (0.00%)
    3 / 32 (9.38%)
    0 / 32 (0.00%)
    4 / 32 (12.50%)
    2 / 24 (8.33%)
    5 / 24 (20.83%)
    0 / 9 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    1
    0
    0
    0
    3
    7
    0
    3
    0
    7
    2
    9
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 11 (18.18%)
    3 / 10 (30.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    3 / 11 (27.27%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    2 / 8 (25.00%)
    0 / 2 (0.00%)
    8 / 35 (22.86%)
    8 / 35 (22.86%)
    0 / 17 (0.00%)
    2 / 32 (6.25%)
    1 / 32 (3.13%)
    9 / 32 (28.13%)
    6 / 24 (25.00%)
    3 / 24 (12.50%)
    3 / 9 (33.33%)
         occurrences all number
    1
    2
    5
    0
    0
    3
    1
    0
    2
    0
    15
    19
    0
    2
    1
    18
    6
    4
    3
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 10 (0.00%)
    3 / 11 (27.27%)
    2 / 10 (20.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    3 / 11 (27.27%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    2 / 8 (25.00%)
    0 / 2 (0.00%)
    10 / 35 (28.57%)
    9 / 35 (25.71%)
    0 / 17 (0.00%)
    2 / 32 (6.25%)
    4 / 32 (12.50%)
    9 / 32 (28.13%)
    5 / 24 (20.83%)
    7 / 24 (29.17%)
    0 / 9 (0.00%)
         occurrences all number
    0
    3
    4
    2
    0
    4
    0
    0
    2
    0
    17
    13
    0
    6
    4
    14
    5
    9
    0
    Blood creatinine increased
         subjects affected / exposed
    3 / 10 (30.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    2 / 35 (5.71%)
    2 / 35 (5.71%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    2 / 32 (6.25%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences all number
    6
    0
    0
    1
    0
    0
    0
    0
    0
    0
    2
    4
    0
    2
    1
    2
    0
    1
    0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    International normalised ratio increased
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    3 / 35 (8.57%)
    3 / 35 (8.57%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    3 / 24 (12.50%)
    0 / 9 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    1
    0
    0
    0
    3
    3
    0
    0
    0
    1
    0
    3
    0
    Lipase increased
         subjects affected / exposed
    4 / 10 (40.00%)
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    1 / 8 (12.50%)
    1 / 1 (100.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    2 / 8 (25.00%)
    0 / 2 (0.00%)
    6 / 35 (17.14%)
    3 / 35 (8.57%)
    0 / 17 (0.00%)
    4 / 32 (12.50%)
    2 / 32 (6.25%)
    1 / 32 (3.13%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    7
    2
    2
    2
    2
    1
    0
    0
    2
    0
    7
    12
    0
    16
    2
    1
    1
    0
    2
    Lymphocyte count decreased
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    4 / 35 (11.43%)
    5 / 35 (14.29%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    3 / 32 (9.38%)
    2 / 24 (8.33%)
    4 / 24 (16.67%)
    0 / 9 (0.00%)
         occurrences all number
    4
    1
    4
    0
    0
    0
    0
    0
    0
    0
    12
    13
    0
    0
    0
    5
    2
    4
    0
    Weight decreased
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    3 / 10 (30.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    2 / 7 (28.57%)
    1 / 7 (14.29%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    9 / 35 (25.71%)
    7 / 35 (20.00%)
    1 / 17 (5.88%)
    3 / 32 (9.38%)
    2 / 32 (6.25%)
    5 / 32 (15.63%)
    4 / 24 (16.67%)
    5 / 24 (20.83%)
    2 / 9 (22.22%)
         occurrences all number
    1
    0
    3
    0
    0
    1
    2
    1
    1
    0
    9
    7
    1
    3
    2
    5
    4
    5
    2
    Transaminases increased
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    2 / 35 (5.71%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    Platelet count decreased
         subjects affected / exposed
    2 / 10 (20.00%)
    2 / 11 (18.18%)
    2 / 10 (20.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    7 / 35 (20.00%)
    8 / 35 (22.86%)
    1 / 17 (5.88%)
    1 / 32 (3.13%)
    5 / 32 (15.63%)
    9 / 32 (28.13%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences all number
    3
    4
    2
    0
    0
    0
    0
    0
    0
    0
    10
    23
    1
    1
    6
    14
    0
    4
    0
    Neutrophil count decreased
         subjects affected / exposed
    1 / 10 (10.00%)
    4 / 11 (36.36%)
    2 / 10 (20.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    10 / 35 (28.57%)
    7 / 35 (20.00%)
    4 / 17 (23.53%)
    14 / 32 (43.75%)
    8 / 32 (25.00%)
    15 / 32 (46.88%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    4 / 9 (44.44%)
         occurrences all number
    1
    15
    3
    1
    0
    0
    0
    0
    1
    0
    17
    12
    21
    17
    18
    31
    1
    0
    4
    Weight increased
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    White blood cell count decreased
         subjects affected / exposed
    2 / 10 (20.00%)
    2 / 11 (18.18%)
    2 / 10 (20.00%)
    2 / 8 (25.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    8 / 35 (22.86%)
    9 / 35 (25.71%)
    1 / 17 (5.88%)
    1 / 32 (3.13%)
    6 / 32 (18.75%)
    6 / 32 (18.75%)
    2 / 24 (8.33%)
    2 / 24 (8.33%)
    1 / 9 (11.11%)
         occurrences all number
    2
    4
    7
    2
    0
    0
    0
    1
    0
    0
    13
    13
    17
    1
    15
    9
    2
    3
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    2 / 35 (5.71%)
    2 / 35 (5.71%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    3
    3
    0
    1
    0
    1
    0
    0
    1
    Contusion
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    2 / 35 (5.71%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    1
    0
    0
    0
    0
    0
    Infusion related reaction
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    2 / 32 (6.25%)
    2 / 32 (6.25%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    2
    0
    0
    3
    3
    Procedural pain
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    2 / 35 (5.71%)
    0 / 17 (0.00%)
    2 / 32 (6.25%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    3 / 24 (12.50%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    2
    0
    2
    1
    1
    0
    3
    0
    Post procedural complication
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Stoma site pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Vascular access site oedema
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Stoma site ulcer
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Vascular access site pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Vascular access site rash
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    Cardiac dysfunction
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Palpitations
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Sinus tachycardia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 1 (100.00%)
    0 / 11 (0.00%)
    3 / 7 (42.86%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    1 / 24 (4.17%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    3
    0
    0
    0
    1
    0
    0
    2
    0
    1
    1
    1
    0
    Nervous system disorders
    Burning sensation
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Cerebellar infarction
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    1 / 2 (50.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Cholinergic syndrome
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Dysgeusia
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 11 (9.09%)
    2 / 10 (20.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    2 / 7 (28.57%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    5 / 35 (14.29%)
    8 / 35 (22.86%)
    1 / 17 (5.88%)
    3 / 32 (9.38%)
    2 / 32 (6.25%)
    5 / 32 (15.63%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    2 / 9 (22.22%)
         occurrences all number
    15
    1
    2
    1
    0
    0
    2
    0
    1
    0
    6
    8
    1
    3
    2
    5
    0
    1
    2
    Dysaesthesia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dizziness
         subjects affected / exposed
    3 / 10 (30.00%)
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    2 / 7 (28.57%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    6 / 35 (17.14%)
    9 / 35 (25.71%)
    2 / 17 (11.76%)
    2 / 32 (6.25%)
    1 / 32 (3.13%)
    7 / 32 (21.88%)
    4 / 24 (16.67%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    14
    1
    1
    1
    0
    1
    0
    2
    0
    0
    7
    15
    3
    2
    1
    7
    4
    0
    0
    Narcolepsy
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Muscle contractions involuntary
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Headache
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 11 (9.09%)
    2 / 10 (20.00%)
    3 / 8 (37.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    2 / 8 (25.00%)
    0 / 2 (0.00%)
    9 / 35 (25.71%)
    4 / 35 (11.43%)
    1 / 17 (5.88%)
    2 / 32 (6.25%)
    3 / 32 (9.38%)
    3 / 32 (9.38%)
    3 / 24 (12.50%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    1
    4
    4
    0
    0
    0
    1
    3
    0
    12
    6
    1
    2
    3
    3
    3
    0
    0
    Neuropathy peripheral
         subjects affected / exposed
    2 / 10 (20.00%)
    1 / 11 (9.09%)
    2 / 10 (20.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    6 / 35 (17.14%)
    6 / 35 (17.14%)
    1 / 17 (5.88%)
    2 / 32 (6.25%)
    3 / 32 (9.38%)
    5 / 32 (15.63%)
    3 / 24 (12.50%)
    3 / 24 (12.50%)
    0 / 9 (0.00%)
         occurrences all number
    2
    1
    2
    0
    0
    1
    0
    0
    0
    0
    6
    7
    1
    2
    3
    5
    3
    4
    0
    Paraesthesia
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    2 / 35 (5.71%)
    4 / 35 (11.43%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    0
    0
    0
    0
    2
    6
    1
    0
    0
    0
    0
    1
    0
    Peripheral motor neuropathy
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    3 / 35 (8.57%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    1
    0
    0
    0
    Restless legs syndrome
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Polyneuropathy
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 11 (18.18%)
    1 / 10 (10.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    11 / 35 (31.43%)
    17 / 35 (48.57%)
    2 / 17 (11.76%)
    5 / 32 (15.63%)
    0 / 32 (0.00%)
    8 / 32 (25.00%)
    0 / 24 (0.00%)
    4 / 24 (16.67%)
    0 / 9 (0.00%)
         occurrences all number
    4
    3
    1
    2
    0
    0
    0
    0
    0
    0
    12
    21
    2
    5
    0
    8
    0
    4
    0
    Tremor
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    2 / 32 (6.25%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    1
    0
    Syncope
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    3 / 35 (8.57%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    4
    0
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 10 (40.00%)
    5 / 11 (45.45%)
    5 / 10 (50.00%)
    4 / 8 (50.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    2 / 7 (28.57%)
    3 / 7 (42.86%)
    4 / 8 (50.00%)
    0 / 2 (0.00%)
    20 / 35 (57.14%)
    21 / 35 (60.00%)
    3 / 17 (17.65%)
    5 / 32 (15.63%)
    5 / 32 (15.63%)
    20 / 32 (62.50%)
    4 / 24 (16.67%)
    7 / 24 (29.17%)
    4 / 9 (44.44%)
         occurrences all number
    9
    9
    6
    4
    0
    1
    2
    3
    8
    0
    28
    34
    6
    6
    6
    29
    5
    8
    4
    Febrile neutropenia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Cytopenia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Lymphopenia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    3 / 35 (8.57%)
    6 / 35 (17.14%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    2 / 32 (6.25%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    5
    21
    0
    0
    0
    5
    0
    0
    0
    Leukopenia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    4 / 35 (11.43%)
    5 / 35 (14.29%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    4 / 32 (12.50%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    16
    20
    0
    1
    0
    8
    0
    0
    1
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    1
    0
    0
    1
    0
    0
    0
    Leukocytosis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    Neutropenia
         subjects affected / exposed
    2 / 10 (20.00%)
    2 / 11 (18.18%)
    1 / 10 (10.00%)
    2 / 8 (25.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    7 / 35 (20.00%)
    8 / 35 (22.86%)
    5 / 17 (29.41%)
    8 / 32 (25.00%)
    9 / 32 (28.13%)
    7 / 32 (21.88%)
    2 / 24 (8.33%)
    0 / 24 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    3
    6
    7
    2
    0
    0
    0
    0
    0
    0
    8
    17
    12
    9
    14
    11
    2
    0
    2
    Thrombocytopenia
         subjects affected / exposed
    2 / 10 (20.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    12 / 35 (34.29%)
    9 / 35 (25.71%)
    1 / 17 (5.88%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    6 / 32 (18.75%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    2 / 9 (22.22%)
         occurrences all number
    3
    3
    0
    1
    0
    0
    0
    0
    0
    0
    24
    26
    1
    1
    5
    21
    0
    1
    4
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Blepharospasm
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    Dry eye
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    1
    0
    0
    0
    Eye irritation
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Lacrimation increased
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Photophobia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Photopsia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Vision blurred
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    2 / 35 (5.71%)
    2 / 35 (5.71%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    2
    0
    0
    0
    0
    0
    1
    0
    Vitreous floaters
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    1 / 2 (50.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    Abdominal pain
         subjects affected / exposed
    1 / 10 (10.00%)
    3 / 11 (27.27%)
    4 / 10 (40.00%)
    3 / 8 (37.50%)
    0 / 1 (0.00%)
    2 / 11 (18.18%)
    3 / 7 (42.86%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    9 / 35 (25.71%)
    13 / 35 (37.14%)
    2 / 17 (11.76%)
    10 / 32 (31.25%)
    6 / 32 (18.75%)
    8 / 32 (25.00%)
    6 / 24 (25.00%)
    5 / 24 (20.83%)
    3 / 9 (33.33%)
         occurrences all number
    1
    3
    8
    3
    0
    3
    3
    0
    0
    0
    12
    16
    3
    13
    7
    9
    7
    6
    6
    Abdominal distension
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    3 / 11 (27.27%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    2 / 8 (25.00%)
    0 / 2 (0.00%)
    2 / 35 (5.71%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    3 / 32 (9.38%)
    0 / 32 (0.00%)
    2 / 32 (6.25%)
    1 / 24 (4.17%)
    4 / 24 (16.67%)
    0 / 9 (0.00%)
         occurrences all number
    1
    1
    1
    1
    0
    3
    0
    0
    2
    0
    2
    0
    1
    3
    0
    2
    1
    5
    0
    Abdominal pain lower
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    1
    0
    1
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 11 (18.18%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    1 / 1 (100.00%)
    1 / 11 (9.09%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    2 / 8 (25.00%)
    0 / 2 (0.00%)
    3 / 35 (8.57%)
    3 / 35 (8.57%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    4 / 32 (12.50%)
    2 / 32 (6.25%)
    0 / 24 (0.00%)
    3 / 24 (12.50%)
    1 / 9 (11.11%)
         occurrences all number
    1
    2
    0
    1
    1
    1
    1
    0
    4
    0
    3
    5
    0
    1
    5
    2
    0
    3
    1
    Anal haemorrhage
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Abdominal tenderness
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Anal inflammation
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Anorectal discomfort
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Anal rash
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Ascites
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    3 / 35 (8.57%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    1
    1
    0
    0
    0
    1
    1
    0
    0
    0
    3
    0
    0
    1
    1
    0
    1
    0
    3
    Constipation
         subjects affected / exposed
    3 / 10 (30.00%)
    3 / 11 (27.27%)
    5 / 10 (50.00%)
    4 / 8 (50.00%)
    0 / 1 (0.00%)
    3 / 11 (27.27%)
    3 / 7 (42.86%)
    1 / 7 (14.29%)
    1 / 8 (12.50%)
    1 / 2 (50.00%)
    15 / 35 (42.86%)
    16 / 35 (45.71%)
    5 / 17 (29.41%)
    13 / 32 (40.63%)
    7 / 32 (21.88%)
    12 / 32 (37.50%)
    2 / 24 (8.33%)
    4 / 24 (16.67%)
    3 / 9 (33.33%)
         occurrences all number
    3
    5
    7
    5
    0
    5
    3
    1
    1
    1
    21
    22
    7
    15
    8
    15
    2
    4
    6
    Colitis
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 11 (18.18%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    Defaecation urgency
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    7 / 10 (70.00%)
    2 / 11 (18.18%)
    3 / 10 (30.00%)
    4 / 8 (50.00%)
    1 / 1 (100.00%)
    3 / 11 (27.27%)
    3 / 7 (42.86%)
    1 / 7 (14.29%)
    3 / 8 (37.50%)
    0 / 2 (0.00%)
    19 / 35 (54.29%)
    15 / 35 (42.86%)
    9 / 17 (52.94%)
    13 / 32 (40.63%)
    14 / 32 (43.75%)
    13 / 32 (40.63%)
    7 / 24 (29.17%)
    6 / 24 (25.00%)
    6 / 9 (66.67%)
         occurrences all number
    18
    3
    3
    5
    1
    3
    3
    2
    3
    0
    30
    29
    37
    29
    24
    16
    12
    8
    11
    Dry mouth
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    6 / 35 (17.14%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    2 / 32 (6.25%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    1
    1
    0
    1
    0
    7
    1
    0
    0
    1
    2
    0
    1
    0
    Dyschezia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    0 / 10 (0.00%)
    3 / 11 (27.27%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    1 / 2 (50.00%)
    3 / 35 (8.57%)
    4 / 35 (11.43%)
    2 / 17 (11.76%)
    2 / 32 (6.25%)
    4 / 32 (12.50%)
    1 / 32 (3.13%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    5
    0
    1
    0
    1
    0
    0
    0
    1
    4
    4
    2
    3
    5
    1
    1
    0
    1
    Dysphagia
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 11 (18.18%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    1
    0
    Eructation
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Flatulence
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    3 / 35 (8.57%)
    1 / 35 (2.86%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    2 / 24 (8.33%)
    3 / 24 (12.50%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    3
    1
    1
    0
    1
    0
    2
    3
    0
    Faeces discoloured
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Frequent bowel movements
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 10 (20.00%)
    2 / 11 (18.18%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    2 / 32 (6.25%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    2
    2
    1
    0
    0
    1
    0
    1
    0
    0
    1
    1
    0
    2
    0
    1
    0
    0
    1
    Gingival pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    Gingival bleeding
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Haematochezia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    Haemorrhoids
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    2 / 32 (6.25%)
    2 / 32 (6.25%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    2
    2
    1
    0
    1
    0
    Large intestinal haemorrhage
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Intestinal obstruction
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Ileus
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hypoaesthesia oral
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    2
    0
    0
    0
    0
    Lip pain
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Melaena
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    2 / 32 (6.25%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    1
    0
    Mouth ulceration
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    Nausea
         subjects affected / exposed
    5 / 10 (50.00%)
    7 / 11 (63.64%)
    4 / 10 (40.00%)
    6 / 8 (75.00%)
    0 / 1 (0.00%)
    2 / 11 (18.18%)
    4 / 7 (57.14%)
    1 / 7 (14.29%)
    2 / 8 (25.00%)
    1 / 2 (50.00%)
    21 / 35 (60.00%)
    23 / 35 (65.71%)
    8 / 17 (47.06%)
    12 / 32 (37.50%)
    12 / 32 (37.50%)
    14 / 32 (43.75%)
    5 / 24 (20.83%)
    9 / 24 (37.50%)
    5 / 9 (55.56%)
         occurrences all number
    21
    8
    5
    6
    0
    2
    5
    1
    2
    1
    26
    34
    16
    19
    17
    20
    6
    9
    6
    Oesophageal spasm
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Oral pain
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Proctalgia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Oral dysaesthesia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Oesophagitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    2 / 35 (5.71%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    2
    2
    0
    0
    0
    0
    0
    1
    1
    Toothache
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    Vomiting
         subjects affected / exposed
    3 / 10 (30.00%)
    3 / 11 (27.27%)
    4 / 10 (40.00%)
    1 / 8 (12.50%)
    1 / 1 (100.00%)
    2 / 11 (18.18%)
    5 / 7 (71.43%)
    1 / 7 (14.29%)
    1 / 8 (12.50%)
    1 / 2 (50.00%)
    11 / 35 (31.43%)
    10 / 35 (28.57%)
    6 / 17 (35.29%)
    6 / 32 (18.75%)
    10 / 32 (31.25%)
    9 / 32 (28.13%)
    0 / 24 (0.00%)
    5 / 24 (20.83%)
    2 / 9 (22.22%)
         occurrences all number
    3
    4
    6
    1
    1
    2
    7
    3
    1
    3
    14
    13
    12
    7
    17
    11
    0
    5
    2
    Stomatitis
         subjects affected / exposed
    2 / 10 (20.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    2 / 8 (25.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    7 / 35 (20.00%)
    7 / 35 (20.00%)
    4 / 17 (23.53%)
    1 / 32 (3.13%)
    7 / 32 (21.88%)
    6 / 32 (18.75%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    3
    1
    0
    2
    0
    1
    0
    0
    0
    0
    8
    10
    36
    1
    10
    6
    1
    0
    1
    Hepatobiliary disorders
    Hepatic pain
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    Hypertransaminasaemia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    Portal hypertension
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Alopecia
         subjects affected / exposed
    3 / 10 (30.00%)
    3 / 11 (27.27%)
    2 / 10 (20.00%)
    5 / 8 (62.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    11 / 35 (31.43%)
    13 / 35 (37.14%)
    3 / 17 (17.65%)
    10 / 32 (31.25%)
    7 / 32 (21.88%)
    12 / 32 (37.50%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    1 / 9 (11.11%)
         occurrences all number
    3
    3
    2
    5
    0
    0
    0
    0
    0
    0
    11
    16
    3
    10
    7
    12
    0
    1
    1
    Dermatitis acneiform
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    3 / 8 (37.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    3 / 35 (8.57%)
    1 / 35 (2.86%)
    1 / 17 (5.88%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    2 / 24 (8.33%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    4
    0
    0
    0
    0
    1
    0
    3
    1
    1
    1
    1
    0
    2
    1
    0
    Dry skin
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    2 / 17 (11.76%)
    1 / 32 (3.13%)
    3 / 32 (9.38%)
    2 / 32 (6.25%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    1
    1
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    3
    2
    0
    0
    1
    Hyperhidrosis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    3 / 32 (9.38%)
    3 / 32 (9.38%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    1
    0
    3
    4
    0
    0
    0
    0
    Erythema
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    4 / 35 (11.43%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    2
    4
    0
    0
    0
    1
    0
    0
    0
    Ecchymosis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nail ridging
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Nail disorder
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nail discolouration
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Night sweats
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    2 / 35 (5.71%)
    2 / 35 (5.71%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    2
    2
    0
    0
    0
    0
    0
    0
    0
    Petechiae
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Pain of skin
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Onycholysis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Photosensitivity reaction
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Rash erythematous
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Rash
         subjects affected / exposed
    0 / 10 (0.00%)
    3 / 11 (27.27%)
    2 / 10 (20.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    13 / 35 (37.14%)
    9 / 35 (25.71%)
    2 / 17 (11.76%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    3 / 32 (9.38%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    3
    6
    1
    0
    0
    0
    0
    1
    0
    22
    9
    2
    1
    2
    3
    1
    0
    2
    Pruritus
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 11 (18.18%)
    1 / 10 (10.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    5 / 35 (14.29%)
    3 / 35 (8.57%)
    1 / 17 (5.88%)
    3 / 32 (9.38%)
    0 / 32 (0.00%)
    3 / 32 (9.38%)
    4 / 24 (16.67%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    2
    1
    2
    0
    1
    0
    1
    1
    0
    6
    3
    2
    3
    0
    3
    4
    0
    0
    Rash maculo-papular
         subjects affected / exposed
    0 / 10 (0.00%)
    3 / 11 (27.27%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    8 / 35 (22.86%)
    7 / 35 (20.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    4 / 32 (12.50%)
    2 / 24 (8.33%)
    0 / 24 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    0
    3
    0
    2
    0
    0
    0
    0
    1
    0
    10
    11
    0
    0
    1
    4
    2
    0
    2
    Rash papular
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    Skin hyperpigmentation
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    3 / 35 (8.57%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    1
    0
    0
    0
    0
    Skin discolouration
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    Rash pruritic
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Xeroderma
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Renal and urinary disorders
    Bladder pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Acute kidney injury
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    1
    1
    0
    1
    0
    0
    Chromaturia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    3
    0
    0
    0
    Dysuria
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    3 / 35 (8.57%)
    3 / 35 (8.57%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    3
    3
    0
    0
    0
    0
    0
    0
    0
    Haematuria
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    2
    1
    0
    1
    0
    Hydronephrosis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Pollakiuria
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    4 / 35 (11.43%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    2 / 32 (6.25%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    2
    4
    0
    0
    1
    2
    0
    0
    0
    Proteinuria
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Urinary incontinence
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    Urinary tract obstruction
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    5 / 35 (14.29%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    5
    1
    0
    1
    1
    1
    1
    0
    0
    Hyperthyroidism
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 10 (20.00%)
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    6 / 35 (17.14%)
    6 / 35 (17.14%)
    0 / 17 (0.00%)
    2 / 32 (6.25%)
    0 / 32 (0.00%)
    5 / 32 (15.63%)
    3 / 24 (12.50%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences all number
    2
    2
    1
    0
    0
    2
    0
    0
    1
    0
    6
    6
    0
    2
    0
    5
    3
    1
    0
    Back pain
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 11 (18.18%)
    2 / 10 (20.00%)
    2 / 8 (25.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    3 / 35 (8.57%)
    8 / 35 (22.86%)
    1 / 17 (5.88%)
    4 / 32 (12.50%)
    5 / 32 (15.63%)
    2 / 32 (6.25%)
    2 / 24 (8.33%)
    2 / 24 (8.33%)
    3 / 9 (33.33%)
         occurrences all number
    1
    2
    4
    2
    0
    1
    0
    1
    1
    0
    3
    9
    1
    4
    5
    2
    2
    2
    4
    Bone pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    1
    1
    0
    0
    0
    0
    Flank pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    2 / 8 (25.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    3 / 35 (8.57%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    2
    0
    0
    1
    0
    0
    0
    1
    4
    0
    1
    1
    0
    0
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    2 / 35 (5.71%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    4
    1
    0
    0
    0
    0
    0
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    Muscular weakness
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    3 / 35 (8.57%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    2 / 32 (6.25%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    1 / 24 (4.17%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    3
    1
    0
    2
    0
    1
    1
    1
    0
    Muscle spasms
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    2 / 32 (6.25%)
    0 / 32 (0.00%)
    2 / 32 (6.25%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    0
    0
    1
    1
    0
    1
    1
    0
    2
    0
    2
    0
    0
    0
    Myalgia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    2 / 10 (20.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    4 / 35 (11.43%)
    4 / 35 (11.43%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    3 / 24 (12.50%)
    0 / 24 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    5
    7
    0
    0
    1
    1
    3
    0
    2
    Neck pain
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    2 / 32 (6.25%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
    1 / 24 (4.17%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    2
    0
    1
    1
    0
    Pain in extremity
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    2 / 10 (20.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    2 / 35 (5.71%)
    4 / 35 (11.43%)
    2 / 17 (11.76%)
    5 / 32 (15.63%)
    0 / 32 (0.00%)
    2 / 32 (6.25%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    3
    0
    0
    1
    0
    0
    0
    0
    2
    5
    3
    5
    0
    2
    2
    0
    1
    Tendonitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Anorectal infection
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Bacteraemia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Bronchitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    1
    COVID-19
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Campylobacter gastroenteritis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    Cellulitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    2 / 10 (20.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    3 / 35 (8.57%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    1
    3
    0
    0
    0
    0
    1
    0
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    2 / 17 (11.76%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Cystitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Diverticulitis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Fungal infection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Escherichia bacteraemia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Enterobacter infection
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Oral candidiasis
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 11 (18.18%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    2 / 35 (5.71%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    1
    0
    0
    0
    0
    3
    0
    1
    1
    1
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    2 / 35 (5.71%)
    0 / 17 (0.00%)
    2 / 32 (6.25%)
    3 / 32 (9.38%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    2
    4
    0
    1
    0
    0
    Mucosal infection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Paronychia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Pneumonia
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    3 / 35 (8.57%)
    2 / 35 (5.71%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    0
    0
    0
    0
    3
    2
    0
    0
    1
    0
    0
    0
    0
    Rhinitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    2 / 35 (5.71%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    0
    0
    0
    0
    0
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    1
    0
    0
    0
    0
    0
    0
    Rash pustular
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    2 / 35 (5.71%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    Pyuria
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    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 / 10 (0.00%)
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    3 / 8 (37.50%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    3 / 35 (8.57%)
    2 / 35 (5.71%)
    1 / 17 (5.88%)
    3 / 32 (9.38%)
    3 / 32 (9.38%)
    2 / 32 (6.25%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    1
    3
    0
    1
    2
    1
    1
    0
    3
    2
    2
    3
    3
    2
    4
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 11 (18.18%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    2 / 32 (6.25%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    2
    1
    1
    0
    0
    0
    Sepsis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    Sinusitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    1
    0
    0
    1
    1
    0
    0
    0
    Viral infection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Vascular device infection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    3 / 35 (8.57%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Dehydration
         subjects affected / exposed
    2 / 10 (20.00%)
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    2 / 7 (28.57%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    1 / 35 (2.86%)
    3 / 17 (17.65%)
    5 / 32 (15.63%)
    2 / 32 (6.25%)
    3 / 32 (9.38%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    2
    1
    1
    0
    0
    0
    2
    1
    0
    0
    2
    11
    3
    9
    2
    3
    1
    0
    0
    Decreased appetite
         subjects affected / exposed
    3 / 10 (30.00%)
    5 / 11 (45.45%)
    2 / 10 (20.00%)
    3 / 8 (37.50%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    2 / 7 (28.57%)
    2 / 7 (28.57%)
    4 / 8 (50.00%)
    0 / 2 (0.00%)
    16 / 35 (45.71%)
    17 / 35 (48.57%)
    3 / 17 (17.65%)
    10 / 32 (31.25%)
    6 / 32 (18.75%)
    12 / 32 (37.50%)
    7 / 24 (29.17%)
    7 / 24 (29.17%)
    4 / 9 (44.44%)
         occurrences all number
    20
    5
    2
    3
    0
    1
    2
    2
    6
    0
    19
    24
    5
    21
    9
    14
    7
    7
    4
    Hypercalcaemia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    2 / 35 (5.71%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    5
    0
    0
    0
    0
    0
    1
    0
    0
    Hypernatraemia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Hypermagnesaemia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    2 / 35 (5.71%)
    1 / 35 (2.86%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    0
    1
    0
    0
    1
    0
    0
    Hyperkalaemia
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    2 / 35 (5.71%)
    2 / 35 (5.71%)
    0 / 17 (0.00%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    2 / 32 (6.25%)
    1 / 24 (4.17%)
    2 / 24 (8.33%)
    1 / 9 (11.11%)
         occurrences all number
    3
    0
    0
    0
    0
    1
    0
    1
    0
    0
    2
    4
    0
    1
    2
    2
    1
    2
    2
    Hyperglycaemia
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 11 (9.09%)
    2 / 10 (20.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    5 / 35 (14.29%)
    9 / 35 (25.71%)
    1 / 17 (5.88%)
    4 / 32 (12.50%)
    0 / 32 (0.00%)
    5 / 32 (15.63%)
    3 / 24 (12.50%)
    7 / 24 (29.17%)
    1 / 9 (11.11%)
         occurrences all number
    1
    1
    5
    0
    0
    0
    0
    0
    0
    0
    19
    24
    2
    9
    0
    10
    8
    11
    2
    Hypocalcaemia
         subjects affected / exposed
    1 / 10 (10.00%)
    3 / 11 (27.27%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    6 / 35 (17.14%)
    6 / 35 (17.14%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    7 / 32 (21.88%)
    1 / 24 (4.17%)
    2 / 24 (8.33%)
    0 / 9 (0.00%)
         occurrences all number
    1
    4
    2
    0
    0
    0
    0
    0
    0
    0
    9
    11
    1
    0
    0
    10
    1
    3
    0
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 11 (9.09%)
    3 / 10 (30.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    8 / 35 (22.86%)
    10 / 35 (28.57%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    6 / 32 (18.75%)
    1 / 24 (4.17%)
    5 / 24 (20.83%)
    1 / 9 (11.11%)
         occurrences all number
    1
    1
    5
    0
    0
    0
    0
    0
    1
    0
    10
    20
    0
    0
    0
    7
    1
    5
    1
    Hyperuricaemia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    2 / 8 (25.00%)
    0 / 2 (0.00%)
    1 / 35 (2.86%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    1 / 32 (3.13%)
    1 / 32 (3.13%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    0
    1
    2
    0
    2
    0
    1
    0
    2
    1
    2
    0
    1
    Hypoglycaemia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    2 / 35 (5.71%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    1
    0
    0
    Hyperphosphataemia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hypophosphataemia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    5 / 35 (14.29%)
    5 / 35 (14.29%)
    0 / 17 (0.00%)
    2 / 32 (6.25%)
    1 / 32 (3.13%)
    5 / 32 (15.63%)
    1 / 24 (4.17%)
    1 / 24 (4.17%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    2
    1
    0
    15
    7
    0
    2
    1
    7
    1
    1
    1
    Hyponatraemia
         subjects affected / exposed
    0 / 10 (0.00%)
    4 / 11 (36.36%)
    1 / 10 (10.00%)
    2 / 8 (25.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    1 / 8 (12.50%)
    0 / 2 (0.00%)
    8 / 35 (22.86%)
    5 / 35 (14.29%)
    0 / 17 (0.00%)
    3 / 32 (9.38%)
    0 / 32 (0.00%)
    7 / 32 (21.88%)
    1 / 24 (4.17%)
    2 / 24 (8.33%)
    0 / 9 (0.00%)
         occurrences all number
    0
    5
    1
    2
    0
    0
    0
    1
    2
    0
    15
    11
    0
    3
    0
    10
    1
    3
    0
    Hypomagnesaemia
         subjects affected / exposed
    3 / 10 (30.00%)
    2 / 11 (18.18%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    4 / 35 (11.43%)
    4 / 35 (11.43%)
    1 / 17 (5.88%)
    5 / 32 (15.63%)
    0 / 32 (0.00%)
    4 / 32 (12.50%)
    0 / 24 (0.00%)
    2 / 24 (8.33%)
    0 / 9 (0.00%)
         occurrences all number
    8
    3
    0
    0
    0
    0
    0
    4
    0
    0
    5
    7
    1
    11
    0
    4
    0
    2
    0
    Hypokalaemia
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 11 (18.18%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    1 / 11 (9.09%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    7 / 35 (20.00%)
    6 / 35 (17.14%)
    2 / 17 (11.76%)
    5 / 32 (15.63%)
    1 / 32 (3.13%)
    4 / 32 (12.50%)
    0 / 24 (0.00%)
    2 / 24 (8.33%)
    2 / 9 (22.22%)
         occurrences all number
    1
    2
    1
    0
    0
    2
    0
    2
    0
    0
    16
    17
    3
    8
    3
    8
    0
    3
    2
    Hypovolaemia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    0 / 17 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Vitamin D deficiency
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 1 (0.00%)
    0 / 11 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 35 (0.00%)
    0 / 35 (0.00%)
    1 / 17 (5.88%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 32 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 May 2017
    Original protocol
    28 Jun 2017
    Number of patients in each cohort specified in Part 1 and 2. The sample sizes for cohorts in Part 2 are based on the number of evaluable participants needed to support a decision whether or not a treatment is effective using target and historic response rates, while controlling Type 1 error. Clarification in response to FDA feedback. Inclusion criteria to ensure that patients received appropriate prior therapy. Inclusion criteria was modified to ensure that participants received appropriate prior therapy. Inclusion criteria was modified to ensure that participants received appropriate prior therapy. Grade 4 laboratory abnormalities will be considered DLT. Administration of biologics was updated to acknowledge different local standard of care practices. Safety stopping rules added for Part 2 of the study. List of clinical laboratory assessments updated to align with hepatitis C testing described in exclusion criteria. PBMC sample collections are not needed. Correction of error in Table for Arm A.
    11 Sep 2017
    Overall survival is being added as an exploratory endpoint as a direct measure of clinical benefit. In response to health authority feedback, pharmacokinetics (PK) samples will be collected to assess the potential for a drug-drug interaction. A Survival Follow-up period was added to the study design and Schedule of Activities to assess the clinical benefit of study treatments. In response to health authority feedback, PK samples will be collected to assess the potential for a drug-drug interaction. Collection of plasma ctDNA for analysis will enable assessments of tumor mutations, tumor mutation burden, and other biomarkers. Overall survival is being added as an exploratory endpoint as a direct measure of clinical benefit. List of clinical laboratory assessments updated to align with amylase testing described in Nonhepatic Nonhematologic DLT [Section 7.4.1, 3), a), v), (3)] and Guidelines for Permanent Discontinuation in Nivolumab (Arm C) [Section 7.4.7.3, 7), d)].
    07 May 2018
    -Randomization was added to Part 2 to better evaluate safety and efficacy of the BMS-813160 + chemotherapy combination. A second dose was added to Arm A to test PK, PD, and efficacy of lower dose of BMS-813160 in combination with chemotherapy. - Randomization was added to Part 2 to better evaluate safety and efficacy of BMS-813160 + chemotherapy +/- nivolumab. A combination of BMS-813160 + nivolumab + Gem/nab-paclitaxel combination was added to Arm B to evaluate safety and preliminary efficacy of the combination. - FOLFIRI retreatment and MSI-H post PD-1 cohorts were removed from the study. Bevacizumab can be added to 2L FOLFIRI treatment if appropriate. A staggered dosing (sentinel participant) approach and safety lead in will reduce the number of patients enrolled to the combination if there are any unanticipated toxicities. Study objectives and endpoints were updated to align with revisions to the Part 2 study design. The exploratory BMS-813160 600 mg BID dosing regimen was not initiated in Part 1 of the study, and this regimen will not be explored in Part 2. Eligible participants on the control arms of Arm A and B will be allowed to cross over at the time of PD as they may be eligible for Arm C. Follow-up period extended to monitor for AEs, accounting for the long half-life of nivolumab. Sections were updated to align with revisions in Part 2 of the study design and Section 10.1, Sample Size Determination. Section 2 timing and events tables were updated to align with revisions in Part 2 of the study design. On-going clinical safety update of BMS-813160 in Part 1 provided.
    12 Jul 2018
    Table 2-2 and Table 2-7 were added and modified, respectively, to clarify the procedures needed for participants in Part 2 of the study to cross over from Cohorts 1c and 3c to Cohorts 5 and 4, respectively. The study inclusion criteria were reordered to facilitate the transfer of this information in the electronic data capture system (RAVE). An edit check in RAVE will ensure that the site will select the accurate revised new criteria. Table was modified to clarify the biomarker sample collections for cross-over participants. Evolving science indicates that the best collection for the peripheral gene expression profiling analysis is whole blood PAXgene instead of whole blood with isolated PBMC.
    12 Dec 2018
    Short Title added for clarity and alignment with Short Title provided on ClinicalTrials.gov. Clarification of the dose and schedule of BMS-813160 in Part 2 of the study. Clarification of the dose and schedule of BMS-813160 in Part 2 of the study. The phrase in bold was added to clarify the dose and schedule of BMS-813160 in Part 2 of the study. Study formulary updated with the addition of 75-mg and 300-mg BMS-813160 tablets. Statement added based on safety data available from Part 1 of the study. Section updated based on preliminary PK data available from Part 1 of the study. Study formulary updated with the addition of 75-mg and 300-mg BMS-813160 tablets. Rationale for the selection of BMS-813160 300 mg BID dosing regimen for primary investigation in Part 2 of the study.
    05 Dec 2019
    The following key changes were made: - Closed enrollment in Cohort 4 of Part 2. - Removed stratification from the protocol. - Revised time that women of childbearing potential must follow contraception instructions to duration of study therapy plus 10 months.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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