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    Clinical Trial Results:
    A Phase 1/2, Open-Label, Safety, Tolerability, and Efficacy Study of Epacadostat in Combination With Pembrolizumab and Chemotherapy in Subjects With Advanced or Metastatic Solid Tumors (ECHO-207/KEYNOTE-723)

    Summary
    EudraCT number
    2016-004678-16
    Trial protocol
    ES  
    Global end of trial date
    13 Jul 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    29 Jul 2021
    First version publication date
    29 Jul 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    INCB 24360-207 / ECHO-207
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03085914
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Incyte
    Sponsor organisation address
    1801 Augustine Cutoff drive, Wilmington, United States, 19803
    Public contact
    Study Director, Incyte Corporation, 3022744765 18554633463, skanthala@incyte.com
    Scientific contact
    Study Director, Incyte Corporation, 3022744765 18554633463, skanthala@incyte.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
    13 Jul 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jul 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This was an open-label, nonrandomized, Phase 1/2 study designed to determine the safety, tolerability, and efficacy of epacadostat when given in combination with pembrolizumab and 7 different chemotherapy regimens described as Treatment Groups A through G. Phase 1 consisted of a 3 + 3 + 3 design intended to determine the MTD or PAD of epacadostat when given in combination with pembrolizumab and chemotherapy; efficacy was also explored. Phase 2 was designed to enroll efficacy expansion cohorts to further evaluate the safety, tolerability, and efficacy of epacadostat at the MTD or PAD (as selected in Phase 1) when given in combination with pembrolizumab and chemotherapy. No participants were enrolled in any Phase 2 efficacy expansion cohort.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    02 May 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
    United States: 70
    Worldwide total number of subjects
    70
    EEA total number of subjects
    0
    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)
    48
    From 65 to 84 years
    22
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 9 US sites. Phase 1 and 2 each consisted of Treatment Groups A-G, and every patient in the same group received the same dose of epacadostat, pembrolizumab and respective chemotherapy regimens. Data analysis and summarization were performed by treatment group, by combining data of the same group in Phase 1 and 2.

    Pre-assignment
    Screening details
    A total of 70 participants were enrolled in the study. Study enrollment was permanently discontinued on 25 Oct 2018 as a strategic decision.

    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
    Group A: Epa + Pembrolizumab +mFOLFOX6
    Arm description
    Epacadostat (Epa, 100 mg ) oral twice-daily (BID) continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg)administered intravenously (IV) in combination with mFOLFOX6 (oxaliplatin IV + leucovorin IV + 5-fluorouracil (5-FU) IV.
    Arm type
    Experimental

    Investigational medicinal product name
    Epacadostat
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    epacadostat was dosed at 100 mg twice a day, if this was not tolerated within a treatment group, epacadostat 50 mg BID was evaluated.

    Arm title
    Group B: Epa + Pembrolizumab + nab-Paclitaxel and Gemcitabine
    Arm description
    Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with nab-paclitaxel IV and gemcitabine IV.
    Arm type
    Experimental

    Investigational medicinal product name
    Epacadostat
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    epacadostat was dosed at 100 mg twice a day, if this was not tolerated within a treatment group, epacadostat 50 mg BID was evaluated.

    Arm title
    Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin
    Arm description
    Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) in combination with paclitaxel IV and carboplatin IV.
    Arm type
    Experimental

    Investigational medicinal product name
    Epacadostat
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    epacadostat was dosed at 100 mg twice a day, if this was not tolerated within a treatment group, epacadostat 50 mg BID was evaluated.

    Arm title
    Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent
    Arm description
    Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with pemetrexed IV and Investigator’s choice of platinum agent: carboplatin IV or cisplatin IV.
    Arm type
    Experimental

    Investigational medicinal product name
    Epacadostat
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    epacadostat was dosed at 100 mg twice a day, if this was not tolerated within a treatment group, epacadostat 50 mg BID was evaluated.

    Arm title
    Group E: Epa + Pembrolizumab + Cyclophosphamide
    Arm description
    Epa (100 mg)oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with cyclophosphamide PO.
    Arm type
    Experimental

    Investigational medicinal product name
    Epacadostat
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    epacadostat was dosed at 100 mg twice a day, if this was not tolerated within a treatment group, epacadostat 50 mg BID was evaluated.

    Arm title
    Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent
    Arm description
    Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with gemcitabine IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.
    Arm type
    Experimental

    Investigational medicinal product name
    Epacostat
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    epacadostat was dosed at 100 mg twice a day, if this was not tolerated within a treatment group, epacadostat 50 mg BID was evaluated.

    Arm title
    Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent
    Arm description
    Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with 5-FU IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.
    Arm type
    Experimental

    Investigational medicinal product name
    Epacadostat
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    epacadostat was dosed at 100 mg twice a day, if this was not tolerated within a treatment group, epacadostat 50 mg BID was evaluated.

    Number of subjects in period 1
    Group A: Epa + Pembrolizumab +mFOLFOX6 Group B: Epa + Pembrolizumab + nab-Paclitaxel and Gemcitabine Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent Group E: Epa + Pembrolizumab + Cyclophosphamide Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent
    Started
    9
    9
    11
    9
    13
    8
    11
    Completed
    0
    0
    0
    0
    0
    0
    0
    Not completed
    9
    9
    11
    9
    13
    8
    11
         Death
    6
    6
    4
    1
    5
    2
    2
         Withdrawal by Participant
    1
    1
    2
    2
    2
    -
    1
         Study terminated by the sponsor.
    -
    -
    -
    1
    2
    1
    -
         Progressive Disease
    -
    -
    2
    2
    1
    1
    1
         Lost to follow-up
    -
    -
    1
    -
    -
    1
    1
         Reason not specified
    2
    2
    2
    3
    3
    3
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A: Epa + Pembrolizumab +mFOLFOX6
    Reporting group description
    Epacadostat (Epa, 100 mg ) oral twice-daily (BID) continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg)administered intravenously (IV) in combination with mFOLFOX6 (oxaliplatin IV + leucovorin IV + 5-fluorouracil (5-FU) IV.

    Reporting group title
    Group B: Epa + Pembrolizumab + nab-Paclitaxel and Gemcitabine
    Reporting group description
    Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with nab-paclitaxel IV and gemcitabine IV.

    Reporting group title
    Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin
    Reporting group description
    Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) in combination with paclitaxel IV and carboplatin IV.

    Reporting group title
    Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent
    Reporting group description
    Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with pemetrexed IV and Investigator’s choice of platinum agent: carboplatin IV or cisplatin IV.

    Reporting group title
    Group E: Epa + Pembrolizumab + Cyclophosphamide
    Reporting group description
    Epa (100 mg)oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with cyclophosphamide PO.

    Reporting group title
    Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent
    Reporting group description
    Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with gemcitabine IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.

    Reporting group title
    Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent
    Reporting group description
    Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with 5-FU IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.

    Reporting group values
    Group A: Epa + Pembrolizumab +mFOLFOX6 Group B: Epa + Pembrolizumab + nab-Paclitaxel and Gemcitabine Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent Group E: Epa + Pembrolizumab + Cyclophosphamide Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent Total
    Number of subjects
    9 9 11 9 13 8 11 70
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 0 0 0 0
        Children (2-11 years)
    0 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0 0 0 0
        Adults (18-64 years)
    8 8 6 6 8 5 7 48
        From 65-84 years
    1 1 5 3 5 3 4 22
        85 years and over
    0 0 0 0 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    55.8 ± 8.03 46.0 ± 14.98 63.7 ± 12.11 58.2 ± 12.96 62.0 ± 10.21 60.3 ± 12.01 59.4 ± 12.24 -
    Sex: Female, Male
    Units:
        Female
    3 4 6 4 10 5 4 36
        Male
    6 5 5 5 3 3 7 34
    Race/Ethnicity, Customized
    Units: Subjects
        White/Caucasian
    7 7 9 8 10 6 8 55
        Black/African-American
    2 1 0 0 1 0 2 6
        Asian
    0 0 1 0 0 2 0 3
        Native Hawaiian/Pacific Islander
    0 0 0 1 0 0 0 1
        Other
    0 1 1 0 2 0 1 5
    Race/Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
    0 0 0 0 0 0 1 1
        Not Hispanic or Latino
    9 9 11 7 13 8 10 67
        Not Reported
    0 0 0 1 0 0 0 1
        Unknown
    0 0 0 1 0 0 0 1

    End points

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    End points reporting groups
    Reporting group title
    Group A: Epa + Pembrolizumab +mFOLFOX6
    Reporting group description
    Epacadostat (Epa, 100 mg ) oral twice-daily (BID) continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg)administered intravenously (IV) in combination with mFOLFOX6 (oxaliplatin IV + leucovorin IV + 5-fluorouracil (5-FU) IV.

    Reporting group title
    Group B: Epa + Pembrolizumab + nab-Paclitaxel and Gemcitabine
    Reporting group description
    Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with nab-paclitaxel IV and gemcitabine IV.

    Reporting group title
    Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin
    Reporting group description
    Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) in combination with paclitaxel IV and carboplatin IV.

    Reporting group title
    Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent
    Reporting group description
    Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with pemetrexed IV and Investigator’s choice of platinum agent: carboplatin IV or cisplatin IV.

    Reporting group title
    Group E: Epa + Pembrolizumab + Cyclophosphamide
    Reporting group description
    Epa (100 mg)oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with cyclophosphamide PO.

    Reporting group title
    Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent
    Reporting group description
    Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with gemcitabine IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.

    Reporting group title
    Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent
    Reporting group description
    Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with 5-FU IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.

    Primary: Phases 1 and 2 : Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs

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    End point title
    Phases 1 and 2 : Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs [1]
    End point description
    A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of epacadostat, pembrolizumab, or chemotherapy. Serious adverse event is defined as an event that meets 1 of the following criteria: is fatal or life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability, incapacity, or a substantial disruption of a person's ability to conduct normal life functions, constitutes a congenital anomaly or birth defect,is a medically important event that may jeopardize the participant or may require medical or surgical intervention to prevent 1 of the outcomes listed above.
    End point type
    Primary
    End point timeframe
    Up to 21 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses for this end point
    End point values
    Group A: Epa + Pembrolizumab +mFOLFOX6 Group B: Epa + Pembrolizumab + nab-Paclitaxel and Gemcitabine Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent Group E: Epa + Pembrolizumab + Cyclophosphamide Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent
    Number of subjects analysed
    9
    9
    11
    9
    13
    8
    11
    Units: participants
        TEAE
    9
    9
    11
    9
    13
    8
    11
        Serious TEAE
    5
    5
    5
    3
    6
    4
    6
    No statistical analyses for this end point

    Primary: Phases 1 and 2: Number of participants with Dose Limiting Toxicities (DLTs)

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    End point title
    Phases 1 and 2: Number of participants with Dose Limiting Toxicities (DLTs) [2]
    End point description
    A DLT was defined as the occurrence of any of the protocol-specified toxicities occurring up to and including Day 28 for the cohorts where mFOLFOX6 and nab-paclitaxel/gemcitabine are administered and Day 21 for all other chemotherapy regimens in Phase 1, except those with a clear alternative explanation (eg, disease progression) or transient (≤ 72 hours) abnormal laboratory values without associated clinically significant signs or symptoms based on investigator determination.
    End point type
    Primary
    End point timeframe
    28 days
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses for this end point
    End point values
    Group A: Epa + Pembrolizumab +mFOLFOX6 Group B: Epa + Pembrolizumab + nab-Paclitaxel and Gemcitabine Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent Group E: Epa + Pembrolizumab + Cyclophosphamide Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent
    Number of subjects analysed
    9
    9
    11
    9
    13
    8
    11
    Units: participants
    0
    2
    0
    0
    0
    0
    3
    No statistical analyses for this end point

    Primary: Phases 1 and 2 : Objective Response Rate (ORR)

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    End point title
    Phases 1 and 2 : Objective Response Rate (ORR) [3]
    End point description
    ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
    End point type
    Primary
    End point timeframe
    Up to Week 18
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses for this end point
    End point values
    Group A: Epa + Pembrolizumab +mFOLFOX6 Group B: Epa + Pembrolizumab + nab-Paclitaxel and Gemcitabine Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent Group E: Epa + Pembrolizumab + Cyclophosphamide Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent
    Number of subjects analysed
    9
    9
    11
    9
    13
    8
    11
    Units: Participants
        Complete Response
    0
    0
    1
    0
    0
    0
    0
        Partial Response
    5
    5
    2
    3
    2
    3
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 21 months
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Group A: Epa + Pembrolizumab +mFOLFOX6
    Reporting group description
    Epacadostat (Epa, 100 mg ) oral twice-daily (BID) continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg)administered intravenously (IV) in combination with mFOLFOX6 (oxaliplatin IV + leucovorin IV + 5-fluorouracil (5-FU) IV.

    Reporting group title
    Group B: Epa + Pembrolizumab + nab-Paclitaxel and Gemcitabine
    Reporting group description
    Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with nab-paclitaxel IV and gemcitabine IV.

    Reporting group title
    Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin
    Reporting group description
    Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) in combination with paclitaxel IV and carboplatin IV.

    Reporting group title
    Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent
    Reporting group description
    Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with pemetrexed IV and Investigator’s choice of platinum agent: carboplatin IV or cisplatin IV.

    Reporting group title
    Group E: Epa + Pembrolizumab + Cyclophosphamide
    Reporting group description
    Epa (100 mg)oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with cyclophosphamide PO.

    Reporting group title
    Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent
    Reporting group description
    Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with gemcitabine IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.

    Reporting group title
    Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent
    Reporting group description
    Epa (100 mg) oral BID continuous daily dosing at the protocol-defined dose in combination with pembrolizumab (200 mg) IV in combination with 5-FU IV and Investigator's choice of platinum agent: carboplatin IV or cisplatin IV.

    Reporting group title
    Total
    Reporting group description
    Total

    Serious adverse events
    Group A: Epa + Pembrolizumab +mFOLFOX6 Group B: Epa + Pembrolizumab + nab-Paclitaxel and Gemcitabine Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent Group E: Epa + Pembrolizumab + Cyclophosphamide Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent Total
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 9 (55.56%)
    5 / 9 (55.56%)
    5 / 11 (45.45%)
    3 / 9 (33.33%)
    6 / 13 (46.15%)
    4 / 8 (50.00%)
    6 / 11 (54.55%)
    34 / 70 (48.57%)
         number of deaths (all causes)
    6
    6
    4
    1
    6
    2
    3
    28
         number of deaths resulting from adverse events
    2
    3
    3
    1
    4
    2
    2
    17
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    Orthostatic hypotension
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    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
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cervix cancer metastatic
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Malignant neoplasm progression
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 9 (22.22%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    2 / 13 (15.38%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    4 / 70 (5.71%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 4
    Tumour pain
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    Disease progression
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 9 (0.00%)
    3 / 11 (27.27%)
    1 / 9 (11.11%)
    1 / 13 (7.69%)
    1 / 8 (12.50%)
    1 / 11 (9.09%)
    9 / 70 (12.86%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    0 / 9
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    0 / 8
    Pyrexia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Lower limb fracture
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    Investigations
    Ammonia increased
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    White blood cell count decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Lymphopenia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Pure white cell aplasia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    Dyspnoea
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Spinal cord compression
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    Diarrhoea
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    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
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    3 / 70 (4.29%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    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
    Rectal haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    Small intestinal obstruction
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    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
    Vomiting
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    4 / 70 (5.71%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    1 / 4
         deaths causally related to treatment / all
    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
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    Hepatobiliary disorders
    Bile duct obstruction
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc degeneration
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    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
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    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
    Failure to thrive
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    Hyperammonaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Hyponatraemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    2 / 11 (18.18%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    3 / 70 (4.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Catheter site cellulitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Cellulitis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
    Influenza
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    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
    Large intestine infection
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 1
    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
    Pneumonia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    2 / 70 (2.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Urosepsis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    1 / 70 (1.43%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Group A: Epa + Pembrolizumab +mFOLFOX6 Group B: Epa + Pembrolizumab + nab-Paclitaxel and Gemcitabine Group C: Epa + Pembrolizumab + Paclitaxel and Carboplatin Group D: Epa + Pembrolizumab + Pemetrexed and Platinum Agent Group E: Epa + Pembrolizumab + Cyclophosphamide Group F: Epa + Pembrolizumab + Gemcitabine and Platinum Agent Group G: Epa + Pembrolizumab + 5-FU and Platinum Agent Total
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 9 (100.00%)
    8 / 9 (88.89%)
    11 / 11 (100.00%)
    9 / 9 (100.00%)
    13 / 13 (100.00%)
    8 / 8 (100.00%)
    10 / 11 (90.91%)
    68 / 70 (97.14%)
    Vascular disorders
    Capillary leak syndrome
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    Flushing
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    3 / 70 (4.29%)
         occurrences all number
    2
    0
    0
    1
    1
    0
    0
    4
    Hot flush
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    2 / 70 (2.86%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    2
    Hypertension
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    2 / 70 (2.86%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    2
    Hypotension
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    2 / 70 (2.86%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    2
    Thrombophlebitis superficial
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Thrombosis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Vascular pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasm progression
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    Tumour flare
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Tumour haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    Tumour inflammation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    Tumour pain
         subjects affected / exposed
    2 / 9 (22.22%)
    2 / 9 (22.22%)
    2 / 11 (18.18%)
    2 / 9 (22.22%)
    1 / 13 (7.69%)
    1 / 8 (12.50%)
    2 / 11 (18.18%)
    12 / 70 (17.14%)
         occurrences all number
    2
    2
    3
    2
    1
    1
    2
    13
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    Seasonal allergy
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 9 (22.22%)
    1 / 11 (9.09%)
    1 / 9 (11.11%)
    1 / 13 (7.69%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    7 / 70 (10.00%)
         occurrences all number
    1
    2
    1
    1
    1
    1
    0
    7
    Axillary pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    Catheter site pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    Chest discomfort
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Chills
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    4 / 11 (36.36%)
    2 / 9 (22.22%)
    3 / 13 (23.08%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    9 / 70 (12.86%)
         occurrences all number
    0
    0
    4
    2
    4
    0
    0
    10
    Facial pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    Fatigue
         subjects affected / exposed
    7 / 9 (77.78%)
    5 / 9 (55.56%)
    6 / 11 (54.55%)
    7 / 9 (77.78%)
    6 / 13 (46.15%)
    4 / 8 (50.00%)
    4 / 11 (36.36%)
    39 / 70 (55.71%)
         occurrences all number
    9
    7
    7
    7
    6
    4
    4
    44
    Gait disturbance
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    Generalised oedema
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Influenza like illness
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    3 / 70 (4.29%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    1
    3
    Malaise
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    2 / 70 (2.86%)
         occurrences all number
    2
    1
    0
    0
    0
    0
    0
    3
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    2 / 13 (15.38%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    3 / 70 (4.29%)
         occurrences all number
    0
    0
    0
    1
    3
    0
    0
    4
    Oedema
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    Oedema peripheral
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 9 (22.22%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    5 / 70 (7.14%)
         occurrences all number
    1
    2
    0
    0
    1
    0
    1
    5
    Pain
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    1 / 11 (9.09%)
    1 / 9 (11.11%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    4 / 70 (5.71%)
         occurrences all number
    0
    1
    1
    1
    2
    0
    0
    5
    Pyrexia
         subjects affected / exposed
    2 / 9 (22.22%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    2 / 13 (15.38%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    6 / 70 (8.57%)
         occurrences all number
    2
    1
    0
    1
    2
    0
    0
    6
    Temperature intolerance
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    2 / 70 (2.86%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    2
    Depression
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    2 / 11 (18.18%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    4 / 70 (5.71%)
         occurrences all number
    0
    1
    2
    0
    0
    0
    1
    4
    Insomnia
         subjects affected / exposed
    2 / 9 (22.22%)
    1 / 9 (11.11%)
    2 / 11 (18.18%)
    3 / 9 (33.33%)
    2 / 13 (15.38%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    10 / 70 (14.29%)
         occurrences all number
    2
    1
    2
    3
    2
    0
    0
    10
    Irritability
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Mental status changes
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Reproductive system and breast disorders
    Testicular pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    Vaginal ulceration
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    Incision site pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Infusion related reaction
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    2 / 8 (25.00%)
    0 / 11 (0.00%)
    3 / 70 (4.29%)
         occurrences all number
    1
    0
    0
    0
    0
    2
    0
    3
    Skin abrasion
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    Stoma site haemorrhage
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Stoma site inflammation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Stoma site irritation
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    Stoma site pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    2 / 70 (2.86%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    2
    Tooth fracture
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    3 / 9 (33.33%)
    3 / 9 (33.33%)
    3 / 11 (27.27%)
    3 / 9 (33.33%)
    1 / 13 (7.69%)
    2 / 8 (25.00%)
    1 / 11 (9.09%)
    16 / 70 (22.86%)
         occurrences all number
    3
    3
    3
    3
    1
    3
    1
    17
    Amylase increased
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    3 / 70 (4.29%)
         occurrences all number
    1
    0
    0
    1
    1
    0
    0
    3
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 9 (33.33%)
    3 / 9 (33.33%)
    3 / 11 (27.27%)
    3 / 9 (33.33%)
    1 / 13 (7.69%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    14 / 70 (20.00%)
         occurrences all number
    3
    4
    4
    3
    1
    1
    0
    16
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 9 (22.22%)
    3 / 9 (33.33%)
    3 / 11 (27.27%)
    1 / 9 (11.11%)
    2 / 13 (15.38%)
    2 / 8 (25.00%)
    0 / 11 (0.00%)
    13 / 70 (18.57%)
         occurrences all number
    2
    3
    3
    1
    2
    2
    0
    13
    Blood bilirubin increased
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Blood creatinine increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    3 / 11 (27.27%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    1 / 11 (9.09%)
    6 / 70 (8.57%)
         occurrences all number
    0
    0
    5
    1
    0
    1
    1
    8
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    2
    Blood pressure increased
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    4 / 70 (5.71%)
         occurrences all number
    1
    1
    1
    0
    0
    1
    0
    4
    Lipase increased
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 9 (0.00%)
    2 / 11 (18.18%)
    1 / 9 (11.11%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    7 / 70 (10.00%)
         occurrences all number
    2
    0
    2
    1
    1
    0
    1
    7
    Lymphocyte count decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    2 / 11 (18.18%)
    1 / 9 (11.11%)
    2 / 13 (15.38%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    5 / 70 (7.14%)
         occurrences all number
    0
    0
    2
    1
    2
    0
    0
    5
    Neutrophil count decreased
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    3 / 11 (27.27%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    1 / 8 (12.50%)
    1 / 11 (9.09%)
    8 / 70 (11.43%)
         occurrences all number
    2
    1
    6
    0
    2
    1
    1
    13
    Neutrophil toxic granulation present
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Platelet count decreased
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    2 / 11 (18.18%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    5 / 70 (7.14%)
         occurrences all number
    1
    1
    5
    0
    0
    2
    0
    9
    Shift to the left
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Transaminases increased
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    Weight decreased
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 9 (22.22%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    2 / 13 (15.38%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    6 / 70 (8.57%)
         occurrences all number
    0
    2
    1
    0
    2
    1
    0
    6
    Weight increased
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    White blood cell count decreased
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    3 / 11 (27.27%)
    2 / 9 (22.22%)
    1 / 13 (7.69%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    9 / 70 (12.86%)
         occurrences all number
    2
    1
    7
    2
    3
    1
    0
    16
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    3 / 70 (4.29%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    1
    3
    Sinus tachycardia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 9 (22.22%)
    2 / 9 (22.22%)
    2 / 11 (18.18%)
    1 / 9 (11.11%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    2 / 11 (18.18%)
    10 / 70 (14.29%)
         occurrences all number
    2
    3
    2
    1
    1
    0
    2
    11
    Dysphonia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    2 / 70 (2.86%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    2
    Dyspnoea
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    2 / 11 (18.18%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    3 / 8 (37.50%)
    0 / 11 (0.00%)
    7 / 70 (10.00%)
         occurrences all number
    1
    0
    3
    1
    0
    3
    0
    8
    Dyspnoea exertional
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    3 / 70 (4.29%)
         occurrences all number
    1
    1
    0
    0
    1
    0
    0
    3
    Epistaxis
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 9 (22.22%)
    1 / 11 (9.09%)
    2 / 9 (22.22%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    6 / 70 (8.57%)
         occurrences all number
    0
    2
    1
    2
    0
    1
    0
    6
    Haemoptysis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    2 / 70 (2.86%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    2
    Hiccups
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Hypoxia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    Nasal congestion
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    3 / 70 (4.29%)
         occurrences all number
    1
    0
    1
    0
    1
    0
    0
    3
    Nasal discomfort
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    2 / 70 (2.86%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    2
    Painful respiration
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    Pharyngeal inflammation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Pneumonitis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Pneumothorax
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Productive cough
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    2 / 9 (22.22%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    1 / 11 (9.09%)
    5 / 70 (7.14%)
         occurrences all number
    0
    2
    0
    2
    0
    1
    1
    6
    Pulmonary embolism
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    2 / 11 (18.18%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    2 / 70 (2.86%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    2
    Pulmonary fibrosis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    Wheezing
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    3 / 70 (4.29%)
         occurrences all number
    0
    1
    0
    1
    0
    1
    0
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 9 (22.22%)
    5 / 9 (55.56%)
    4 / 11 (36.36%)
    3 / 9 (33.33%)
    6 / 13 (46.15%)
    4 / 8 (50.00%)
    3 / 11 (27.27%)
    27 / 70 (38.57%)
         occurrences all number
    2
    6
    5
    4
    9
    4
    3
    33
    Increased tendency to bruise
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    Leukocytosis
         subjects affected / exposed
    1 / 9 (11.11%)
    3 / 9 (33.33%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    2 / 8 (25.00%)
    1 / 11 (9.09%)
    8 / 70 (11.43%)
         occurrences all number
    1
    3
    0
    1
    0
    2
    1
    8
    Leukopenia
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    3 / 11 (27.27%)
    2 / 9 (22.22%)
    1 / 13 (7.69%)
    4 / 8 (50.00%)
    1 / 11 (9.09%)
    13 / 70 (18.57%)
         occurrences all number
    2
    3
    3
    2
    1
    8
    1
    20
    Lymph node pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    Lymphadenopathy
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    3 / 70 (4.29%)
         occurrences all number
    0
    0
    1
    1
    0
    1
    0
    3
    Lymphopenia
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 9 (22.22%)
    1 / 11 (9.09%)
    1 / 9 (11.11%)
    4 / 13 (30.77%)
    2 / 8 (25.00%)
    1 / 11 (9.09%)
    11 / 70 (15.71%)
         occurrences all number
    0
    3
    1
    1
    4
    2
    1
    12
    Neutropenia
         subjects affected / exposed
    2 / 9 (22.22%)
    5 / 9 (55.56%)
    5 / 11 (45.45%)
    2 / 9 (22.22%)
    2 / 13 (15.38%)
    5 / 8 (62.50%)
    3 / 11 (27.27%)
    24 / 70 (34.29%)
         occurrences all number
    7
    13
    5
    2
    5
    9
    3
    44
    Thrombocytopenia
         subjects affected / exposed
    1 / 9 (11.11%)
    7 / 9 (77.78%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    4 / 8 (50.00%)
    2 / 11 (18.18%)
    15 / 70 (21.43%)
         occurrences all number
    1
    16
    0
    1
    0
    5
    3
    26
    Nervous system disorders
    Ageusia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    Amnesia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Aphasia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    Dizziness
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    3 / 11 (27.27%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    2 / 11 (18.18%)
    7 / 70 (10.00%)
         occurrences all number
    1
    1
    3
    0
    0
    0
    2
    7
    Dysaesthesia
         subjects affected / exposed
    2 / 9 (22.22%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    3 / 70 (4.29%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    0
    3
    Dysgeusia
         subjects affected / exposed
    3 / 9 (33.33%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    1 / 8 (12.50%)
    2 / 11 (18.18%)
    8 / 70 (11.43%)
         occurrences all number
    3
    2
    0
    0
    1
    1
    2
    9
    Head titubation
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    Headache
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    4 / 11 (36.36%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    2 / 8 (25.00%)
    0 / 11 (0.00%)
    9 / 70 (12.86%)
         occurrences all number
    1
    1
    4
    1
    0
    2
    0
    9
    Hemiparesis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    Hypoaesthesia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    Hypogeusia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    Memory impairment
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Migraine
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Neuropathy peripheral
         subjects affected / exposed
    7 / 9 (77.78%)
    3 / 9 (33.33%)
    5 / 11 (45.45%)
    3 / 9 (33.33%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    19 / 70 (27.14%)
         occurrences all number
    8
    4
    5
    3
    0
    0
    1
    21
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    5 / 11 (45.45%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    8 / 70 (11.43%)
         occurrences all number
    0
    1
    5
    1
    0
    1
    0
    8
    Restless legs syndrome
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    Taste disorder
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Tremor
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    Eye disorders
    Abnormal sensation in eye
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    Blindness transient
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    Cataract
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    Diplopia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    Dry eye
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    3 / 9 (33.33%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    3 / 70 (4.29%)
         occurrences all number
    0
    0
    0
    3
    0
    0
    0
    3
    Eczema eyelids
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    Eye inflammation
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    Eye pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    Lacrimation increased
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    3 / 70 (4.29%)
         occurrences all number
    0
    1
    0
    1
    1
    0
    0
    3
    Periorbital oedema
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Photophobia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    Vision blurred
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    3 / 11 (27.27%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    3 / 70 (4.29%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    0
    3
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Vertigo
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    16
    0
    0
    0
    0
    0
    16
    Abdominal distension
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 9 (22.22%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    4 / 70 (5.71%)
         occurrences all number
    0
    2
    0
    0
    1
    1
    0
    4
    Abdominal hernia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    Abdominal pain
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    2 / 11 (18.18%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    2 / 8 (25.00%)
    1 / 11 (9.09%)
    8 / 70 (11.43%)
         occurrences all number
    1
    1
    3
    0
    1
    2
    1
    9
    Abdominal pain lower
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    3 / 70 (4.29%)
         occurrences all number
    2
    0
    0
    0
    1
    0
    1
    4
    Anal fissure
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    Anal incontinence
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    Anorectal swelling
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Aphthous ulcer
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    Ascites
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Cheilitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Constipation
         subjects affected / exposed
    3 / 9 (33.33%)
    1 / 9 (11.11%)
    3 / 11 (27.27%)
    3 / 9 (33.33%)
    1 / 13 (7.69%)
    2 / 8 (25.00%)
    0 / 11 (0.00%)
    13 / 70 (18.57%)
         occurrences all number
    3
    2
    4
    3
    1
    2
    0
    15
    Defaecation urgency
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    Dental caries
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    Diarrhoea
         subjects affected / exposed
    3 / 9 (33.33%)
    5 / 9 (55.56%)
    6 / 11 (54.55%)
    4 / 9 (44.44%)
    4 / 13 (30.77%)
    0 / 8 (0.00%)
    4 / 11 (36.36%)
    26 / 70 (37.14%)
         occurrences all number
    6
    6
    6
    4
    5
    0
    5
    32
    Dyspepsia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    2 / 70 (2.86%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    2
    Dysphagia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    3 / 11 (27.27%)
    5 / 70 (7.14%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    5
    7
    Epigastric discomfort
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    Eructation
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    2 / 70 (2.86%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    2
    Faeces soft
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Flatulence
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    2 / 70 (2.86%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    2
    Frequent bowel movements
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    2 / 9 (22.22%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    1 / 11 (9.09%)
    5 / 70 (7.14%)
         occurrences all number
    0
    1
    0
    2
    0
    1
    1
    5
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    1 / 11 (9.09%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    4 / 70 (5.71%)
         occurrences all number
    0
    1
    1
    1
    0
    1
    0
    4
    Gingival bleeding
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Haematochezia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Haemorrhoids
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    2 / 70 (2.86%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    2
    Hypoaesthesia oral
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    Hypoaesthesia teeth
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Mouth ulceration
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    1 / 11 (9.09%)
    3 / 70 (4.29%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    1
    3
    Nausea
         subjects affected / exposed
    2 / 9 (22.22%)
    5 / 9 (55.56%)
    8 / 11 (72.73%)
    7 / 9 (77.78%)
    4 / 13 (30.77%)
    4 / 8 (50.00%)
    7 / 11 (63.64%)
    37 / 70 (52.86%)
         occurrences all number
    3
    5
    13
    7
    5
    4
    7
    44
    Oesophageal spasm
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    Oesophagitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Salivary hypersecretion
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    Stomatitis
         subjects affected / exposed
    3 / 9 (33.33%)
    3 / 9 (33.33%)
    2 / 11 (18.18%)
    2 / 9 (22.22%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    5 / 11 (45.45%)
    16 / 70 (22.86%)
         occurrences all number
    3
    4
    2
    3
    1
    0
    7
    20
    Toothache
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 9 (33.33%)
    5 / 11 (45.45%)
    3 / 9 (33.33%)
    3 / 13 (23.08%)
    3 / 8 (37.50%)
    3 / 11 (27.27%)
    20 / 70 (28.57%)
         occurrences all number
    0
    3
    5
    3
    4
    3
    3
    21
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Hydronephrosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    Pollakiuria
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    3 / 70 (4.29%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    1
    3
    Renal salt-wasting syndrome
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Stress urinary incontinence
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    Urinary incontinence
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Product issues
    Stent malfunction
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 9 (11.11%)
    2 / 9 (22.22%)
    5 / 11 (45.45%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    9 / 70 (12.86%)
         occurrences all number
    1
    2
    5
    0
    1
    0
    0
    9
    Blister
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    Decubitus ulcer
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    Dermatitis bullous
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    Dermatitis contact
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Dermatitis exfoliative
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Dermatitis psoriasiform
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Dry skin
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    2 / 70 (2.86%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    2
    Erythema
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    Hyperhidrosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Night sweats
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    2 / 9 (22.22%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    4 / 70 (5.71%)
         occurrences all number
    0
    0
    0
    2
    1
    0
    1
    4
    Palmar erythema
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    2 / 70 (2.86%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    2
    Petechiae
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    Pruritus
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    1 / 11 (9.09%)
    3 / 9 (33.33%)
    1 / 13 (7.69%)
    2 / 8 (25.00%)
    1 / 11 (9.09%)
    10 / 70 (14.29%)
         occurrences all number
    1
    1
    1
    3
    1
    2
    2
    11
    Rash
         subjects affected / exposed
    1 / 9 (11.11%)
    4 / 9 (44.44%)
    3 / 11 (27.27%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    2 / 8 (25.00%)
    3 / 11 (27.27%)
    14 / 70 (20.00%)
         occurrences all number
    2
    5
    3
    0
    1
    2
    4
    17
    Rash erythematous
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Rash maculo-papular
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    3 / 70 (4.29%)
         occurrences all number
    1
    0
    0
    1
    1
    0
    0
    3
    Rash pruritic
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    2 / 13 (15.38%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    3 / 70 (4.29%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    1
    3
    Skin exfoliation
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    3 / 11 (27.27%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    1 / 8 (12.50%)
    1 / 11 (9.09%)
    7 / 70 (10.00%)
         occurrences all number
    1
    0
    3
    0
    1
    1
    2
    8
    Back pain
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    3 / 11 (27.27%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    6 / 70 (8.57%)
         occurrences all number
    1
    0
    3
    0
    1
    1
    0
    6
    Bone pain
         subjects affected / exposed
    1 / 9 (11.11%)
    3 / 9 (33.33%)
    4 / 11 (36.36%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    10 / 70 (14.29%)
         occurrences all number
    1
    3
    5
    1
    0
    1
    0
    11
    Chest wall mass
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    Flank pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    Muscle spasms
         subjects affected / exposed
    2 / 9 (22.22%)
    1 / 9 (11.11%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    4 / 70 (5.71%)
         occurrences all number
    2
    1
    1
    0
    0
    0
    0
    4
    Muscle tightness
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    Muscular weakness
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    3 / 70 (4.29%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    0
    3
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    1 / 11 (9.09%)
    4 / 70 (5.71%)
         occurrences all number
    1
    0
    1
    0
    0
    2
    1
    5
    Musculoskeletal pain
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    2 / 13 (15.38%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    4 / 70 (5.71%)
         occurrences all number
    1
    1
    0
    0
    2
    0
    0
    4
    Myalgia
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 9 (22.22%)
    2 / 11 (18.18%)
    1 / 9 (11.11%)
    1 / 13 (7.69%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    7 / 70 (10.00%)
         occurrences all number
    0
    2
    2
    1
    1
    1
    0
    7
    Neck pain
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    Osteoarthritis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 9 (22.22%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    3 / 70 (4.29%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    0
    3
    Pain in jaw
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    2 / 11 (18.18%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    2 / 70 (2.86%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    2
    Autoimmune thyroiditis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    Hyperthyroidism
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Hypothyroidism
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    2 / 70 (2.86%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    2
    Steroid withdrawal syndrome
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    Thyroiditis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 9 (22.22%)
    2 / 9 (22.22%)
    3 / 11 (27.27%)
    1 / 9 (11.11%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    3 / 11 (27.27%)
    12 / 70 (17.14%)
         occurrences all number
    2
    2
    3
    2
    1
    0
    3
    13
    Dehydration
         subjects affected / exposed
    3 / 9 (33.33%)
    2 / 9 (22.22%)
    1 / 11 (9.09%)
    1 / 9 (11.11%)
    1 / 13 (7.69%)
    1 / 8 (12.50%)
    4 / 11 (36.36%)
    13 / 70 (18.57%)
         occurrences all number
    3
    3
    2
    1
    1
    1
    4
    15
    Fluid retention
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Hypercalcaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    3 / 11 (27.27%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    3 / 70 (4.29%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    0
    3
    Hyperglycaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    Hyperkalaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    1 / 11 (9.09%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    3 / 70 (4.29%)
         occurrences all number
    0
    1
    1
    1
    0
    0
    0
    3
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Hyperuricaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    2
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    2 / 13 (15.38%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    3 / 70 (4.29%)
         occurrences all number
    0
    0
    0
    1
    2
    0
    0
    3
    Hypocalcaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    Hypokalaemia
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    2 / 11 (18.18%)
    3 / 9 (33.33%)
    2 / 13 (15.38%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    10 / 70 (14.29%)
         occurrences all number
    1
    1
    3
    4
    3
    0
    1
    13
    Hypomagnesaemia
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    3 / 11 (27.27%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    7 / 70 (10.00%)
         occurrences all number
    1
    1
    8
    1
    0
    0
    1
    12
    Hyponatraemia
         subjects affected / exposed
    1 / 9 (11.11%)
    1 / 9 (11.11%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    4 / 70 (5.71%)
         occurrences all number
    1
    1
    1
    0
    2
    0
    0
    5
    Hypophosphataemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    2 / 11 (18.18%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    3 / 70 (4.29%)
         occurrences all number
    0
    0
    2
    1
    0
    0
    0
    3
    Hypovolaemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    Iron overload
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Lactic acidosis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    Vitamin D deficiency
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 11 (9.09%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    Infections and infestations
    Bacteroides bacteraemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    Body tinea
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    Bronchitis
         subjects affected / exposed
    0 / 9 (0.00%)
    3 / 9 (33.33%)
    1 / 11 (9.09%)
    2 / 9 (22.22%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    7 / 70 (10.00%)
         occurrences all number
    0
    3
    1
    2
    1
    0
    0
    7
    Candida infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    Cellulitis
         subjects affected / exposed
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    2 / 11 (18.18%)
    3 / 70 (4.29%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    2
    3
    Clostridium bacteraemia
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    2 / 70 (2.86%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    2
    Ear infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    Escherichia infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    1 / 8 (12.50%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    Folliculitis
         subjects affected / exposed
    0 / 9 (0.00%)
    2 / 9 (22.22%)
    2 / 11 (18.18%)
    1 / 9 (11.11%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    5 / 70 (7.14%)
         occurrences all number
    0
    2
    2
    1
    0
    0
    0
    5
    Fungal skin infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    Gingivitis
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    1 / 11 (9.09%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    1
    Herpes virus infection
         subjects affected / exposed
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 13 (7.69%)
    0 / 8 (0.00%)
    0 / 11 (0.00%)
    1 / 70 (1.43%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    Herpes zoster