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    Clinical Trial Results:
    Phase II Trial of CAP7.1 in adult patients with refractory malignancies Small cell lung carcinoma, Non-small cell lung carcinoma, Biliary carcinoma

    Summary
    EudraCT number
    		 2012-002378-30
    Trial protocol
    		 DE  
    Global end of trial date
    10 Apr 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Aug 2018
    First version publication date
    29 Aug 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CPN710102
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02094560
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CellAct Pharma GmbH
    Sponsor organisation address
    Biomedizin Zentrum Dortmund, Otto-Hahn-Str. 15, Dortmund, Germany, 44227
    Public contact
    Nalân Utku, CellAct Pharma GmbH, 49 23197426350, n.utku@cellact.eu
    Scientific contact
    Nalân Utku, CellAct Pharma GmbH, 49 23197426350, n.utku@cellact.eu
    Sponsor organisation name
    Mundipharma EDO GmbH
    Sponsor organisation address
    St. Alban-Rheinweg 74, Basel, Switzerland, CH-4020
    Public contact
    Thomas Mehrling, Mundiparma EDO GmbH, 41 61 205 1473, thomas.mehrling@edoncology.com
    Scientific contact
    Thomas Mehrling, Mundiparma EDO GmbH, 41 61 205 1473, thomas.mehrling@edoncology.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
    02 Dec 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Apr 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of the study was to assess the antitumor activity of CAP7.1 based on the observed objective response rate and rate of disease stabilization using Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.
    Protection of trial subjects
    The study was conducted in agreement with the Declaration of Helsinki (Tokyo, Venice, Hong Kong, Somerset West and Edinburgh amendments) and the laws and regulations of the country, whichever provides the greatest protection of the subject.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Nov 2011
    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
    Germany: 43
    Worldwide total number of subjects
    43
    EEA total number of subjects
    43
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    22
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Overall 45 subjects were enrolled, Of them 43 subjects were treated.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Non-Small Cell Lung Cancer (NSCLC): CAP7.1
    Arm description
    		 Subjects with NSCLC who had progressed despite previous therapies received 60 minutes (min) intravenous infusion of 150 or 200 milligram per square meter (mg/m^2) CAP7.1 daily for 5 consecutive days, followed by a medication free interval of 23 days. The full 28-day treatment cycle (5 days on treatment and 23-day treatment-free interval) was repeated until disease progression, unmanageable toxicity or withdrawal of consent (whichever occurred first), if recovery from haematological and other toxicities was considered adequate.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CAP7.1
    Investigational medicinal product code
    CAP7.1
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received 150 or 200 mg/m^2 (60 min intravenous infusion) of CAP7.1.

    Arm title
    		 Non-Small Cell Lung Cancer (NSCLC): Best Supportive Care (BSC)
    Arm description
    		 Subjects with NSCLC who had progressed despite previous therapies received best support as per institutional standards. In case of progression, these subjects were allowed to cross over to CAP7.1 therapy at the dose of 150 or 200 mg/m^2 (60 min intravenous infusion) daily for 5 consecutive days, followed by a medication free interval of 23 days. The full 28-day treatment cycle (5 days on treatment and 23-day treatment-free interval) was repeated until disease progression, unmanageable toxicity or withdrawal of consent (whichever occurred first), if recovery from haematological and other toxicities was considered adequate.
    Arm type
    		 Best Supportive Care

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Small Cell Lung Cancer (SCLC): CAP7.1
    Arm description
    		 Subjects with SCLC who had progressed despite previous therapies received 60 min intravenous infusion of 150 or 200 mg/m^2 CAP7.1 daily for 5 consecutive days, followed by a medication free interval of 23 days. The full 28-day treatment cycle (5 days on treatment and 23-day treatment-free interval) was repeated until disease progression, unmanageable toxicity or withdrawal of consent (whichever occurred first), if recovery from haematological and other toxicities was considered adequate.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CAP7.1
    Investigational medicinal product code
    CAP7.1
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received 150 or 200 mg/m^2 (60 min intravenous infusion) of CAP7.1.

    Arm title
    		 Biliary tract cancer: CAP7.1
    Arm description
    		 Subjects with advanced biliary tract cancer who had progressed despite previous therapies received 60 min intravenous infusion of 150 or 200 mg/m^2 CAP7.1 daily for 5 consecutive days, followed by a medication free interval of 23 days. The full 28-day treatment cycle (5 days on treatment and 23-day treatment-free interval) was repeated until disease progression, unmanageable toxicity or withdrawal of consent (whichever occurred first), if recovery from haematological and other toxicities was considered adequate.
    Arm type
    		 Experimental

    Investigational medicinal product name
    CAP7.1
    Investigational medicinal product code
    CAP7.1
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received 150 or 200 mg/m^2 (60 min intravenous infusion) of CAP7.1.

    Arm title
    		 Biliary tract cancer: Best Supportive Care (BSC)
    Arm description
    		 Subjects with advanced biliary tract cancer who had progressed despite previous therapies received best support as per institutional standards. In case of progression, these subjects were allowed to cross over to CAP7.1 therapy at the dose of 150 or 200 mg/m^2 (60 min intravenous infusion) daily for 5 consecutive days, followed by a medication free interval of 23 days. The full 28-day treatment cycle (5 days on treatment and 23-day treatment-free interval) was repeated until disease progression, unmanageable toxicity or withdrawal of consent (whichever occurred first), if recovery from haematological and other toxicities was considered adequate.
    Arm type
    		 Best Supportive Care

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Non-Small Cell Lung Cancer (NSCLC): CAP7.1 Non-Small Cell Lung Cancer (NSCLC): Best Supportive Care (BSC) Small Cell Lung Cancer (SCLC): CAP7.1 Biliary tract cancer: CAP7.1 Biliary tract cancer: Best Supportive Care (BSC)
    Started
    4
    4
    8
    14
    13
    Completed
    2
    0
    4
    9
    5
    Not completed
    2
    4
    4
    5
    8
         Consent withdrawn by subject
    -
    2
    -
    -
    1
         Physician decision
    -
    -
    -
    -
    1
         Removed Medically Warranted
    -
    1
    -
    -
    -
         Other
    -
    -
    -
    1
    1
         Progressive Disease
    1
    1
    3
    -
    1
         Screening Failure
    -
    -
    -
    1
    -
         Adverse event
    1
    -
    1
    3
    3
         Lost to follow-up
    -
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Non-Small Cell Lung Cancer (NSCLC): CAP7.1
    Reporting group description
    		 Subjects with NSCLC who had progressed despite previous therapies received 60 minutes (min) intravenous infusion of 150 or 200 milligram per square meter (mg/m^2) CAP7.1 daily for 5 consecutive days, followed by a medication free interval of 23 days. The full 28-day treatment cycle (5 days on treatment and 23-day treatment-free interval) was repeated until disease progression, unmanageable toxicity or withdrawal of consent (whichever occurred first), if recovery from haematological and other toxicities was considered adequate.

    Reporting group title
    Non-Small Cell Lung Cancer (NSCLC): Best Supportive Care (BSC)
    Reporting group description
    		 Subjects with NSCLC who had progressed despite previous therapies received best support as per institutional standards. In case of progression, these subjects were allowed to cross over to CAP7.1 therapy at the dose of 150 or 200 mg/m^2 (60 min intravenous infusion) daily for 5 consecutive days, followed by a medication free interval of 23 days. The full 28-day treatment cycle (5 days on treatment and 23-day treatment-free interval) was repeated until disease progression, unmanageable toxicity or withdrawal of consent (whichever occurred first), if recovery from haematological and other toxicities was considered adequate.

    Reporting group title
    Small Cell Lung Cancer (SCLC): CAP7.1
    Reporting group description
    		 Subjects with SCLC who had progressed despite previous therapies received 60 min intravenous infusion of 150 or 200 mg/m^2 CAP7.1 daily for 5 consecutive days, followed by a medication free interval of 23 days. The full 28-day treatment cycle (5 days on treatment and 23-day treatment-free interval) was repeated until disease progression, unmanageable toxicity or withdrawal of consent (whichever occurred first), if recovery from haematological and other toxicities was considered adequate.

    Reporting group title
    Biliary tract cancer: CAP7.1
    Reporting group description
    		 Subjects with advanced biliary tract cancer who had progressed despite previous therapies received 60 min intravenous infusion of 150 or 200 mg/m^2 CAP7.1 daily for 5 consecutive days, followed by a medication free interval of 23 days. The full 28-day treatment cycle (5 days on treatment and 23-day treatment-free interval) was repeated until disease progression, unmanageable toxicity or withdrawal of consent (whichever occurred first), if recovery from haematological and other toxicities was considered adequate.

    Reporting group title
    Biliary tract cancer: Best Supportive Care (BSC)
    Reporting group description
    		 Subjects with advanced biliary tract cancer who had progressed despite previous therapies received best support as per institutional standards. In case of progression, these subjects were allowed to cross over to CAP7.1 therapy at the dose of 150 or 200 mg/m^2 (60 min intravenous infusion) daily for 5 consecutive days, followed by a medication free interval of 23 days. The full 28-day treatment cycle (5 days on treatment and 23-day treatment-free interval) was repeated until disease progression, unmanageable toxicity or withdrawal of consent (whichever occurred first), if recovery from haematological and other toxicities was considered adequate.

    Reporting group values
    		 Non-Small Cell Lung Cancer (NSCLC): CAP7.1 Non-Small Cell Lung Cancer (NSCLC): Best Supportive Care (BSC) Small Cell Lung Cancer (SCLC): CAP7.1 Biliary tract cancer: CAP7.1 Biliary tract cancer: Best Supportive Care (BSC) Total
    Number of subjects
    		 4 4 8 14 13 43
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 2 2 3 9 6 22
        From 65-84 years
    		 2 2 5 5 7 21
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.0 ( 4.08 ) 61.5 ( 11.00 ) 63.3 ( 8.15 ) 60.3 ( 10.54 ) 65.8 ( 8.70 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2 1 1 6 7 17
        Male
    		 2 3 7 8 6 26

    End points

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    End points reporting groups
    Reporting group title
    Non-Small Cell Lung Cancer (NSCLC): CAP7.1
    Reporting group description
    		 Subjects with NSCLC who had progressed despite previous therapies received 60 minutes (min) intravenous infusion of 150 or 200 milligram per square meter (mg/m^2) CAP7.1 daily for 5 consecutive days, followed by a medication free interval of 23 days. The full 28-day treatment cycle (5 days on treatment and 23-day treatment-free interval) was repeated until disease progression, unmanageable toxicity or withdrawal of consent (whichever occurred first), if recovery from haematological and other toxicities was considered adequate.

    Reporting group title
    Non-Small Cell Lung Cancer (NSCLC): Best Supportive Care (BSC)
    Reporting group description
    		 Subjects with NSCLC who had progressed despite previous therapies received best support as per institutional standards. In case of progression, these subjects were allowed to cross over to CAP7.1 therapy at the dose of 150 or 200 mg/m^2 (60 min intravenous infusion) daily for 5 consecutive days, followed by a medication free interval of 23 days. The full 28-day treatment cycle (5 days on treatment and 23-day treatment-free interval) was repeated until disease progression, unmanageable toxicity or withdrawal of consent (whichever occurred first), if recovery from haematological and other toxicities was considered adequate.

    Reporting group title
    Small Cell Lung Cancer (SCLC): CAP7.1
    Reporting group description
    		 Subjects with SCLC who had progressed despite previous therapies received 60 min intravenous infusion of 150 or 200 mg/m^2 CAP7.1 daily for 5 consecutive days, followed by a medication free interval of 23 days. The full 28-day treatment cycle (5 days on treatment and 23-day treatment-free interval) was repeated until disease progression, unmanageable toxicity or withdrawal of consent (whichever occurred first), if recovery from haematological and other toxicities was considered adequate.

    Reporting group title
    Biliary tract cancer: CAP7.1
    Reporting group description
    		 Subjects with advanced biliary tract cancer who had progressed despite previous therapies received 60 min intravenous infusion of 150 or 200 mg/m^2 CAP7.1 daily for 5 consecutive days, followed by a medication free interval of 23 days. The full 28-day treatment cycle (5 days on treatment and 23-day treatment-free interval) was repeated until disease progression, unmanageable toxicity or withdrawal of consent (whichever occurred first), if recovery from haematological and other toxicities was considered adequate.

    Reporting group title
    Biliary tract cancer: Best Supportive Care (BSC)
    Reporting group description
    		 Subjects with advanced biliary tract cancer who had progressed despite previous therapies received best support as per institutional standards. In case of progression, these subjects were allowed to cross over to CAP7.1 therapy at the dose of 150 or 200 mg/m^2 (60 min intravenous infusion) daily for 5 consecutive days, followed by a medication free interval of 23 days. The full 28-day treatment cycle (5 days on treatment and 23-day treatment-free interval) was repeated until disease progression, unmanageable toxicity or withdrawal of consent (whichever occurred first), if recovery from haematological and other toxicities was considered adequate.

    Primary: Percentage of Subjects With Disease Control

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    End point title
    		 Percentage of Subjects With Disease Control
    End point description
    The rate of disease control was defined as the percentage of subjects who have achieved complete, partial remission and stable disease (CR+PR+SD), according to RECIST 1.1. CR was defined as disappearance of all target lesions/ disappearance of all non-target lesions and normalization of tumor marker level. PR was defined as at least a 30% decrease in the sum of the limited-stage disease (LD) of target lesions, taking as reference the baseline sum LD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started. PD was defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions/appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
    End point type
    Primary
    End point timeframe
    Start of study treatment until 30 days post-last study treatment (approximately 2 years and 9 months)
    End point values
    		 Non-Small Cell Lung Cancer (NSCLC): CAP7.1 Non-Small Cell Lung Cancer (NSCLC): Best Supportive Care (BSC) Small Cell Lung Cancer (SCLC): CAP7.1 Biliary tract cancer: CAP7.1 Biliary tract cancer: Best Supportive Care (BSC)
    Number of subjects analysed
    4 [1]
    3 [2]
    8 [3]
    10 [4]
    10 [5]
    Units: Percentage of subjects
        number (confidence interval 95%)
    50.0 (6.8 to 93.2)
    0.0 (0.0 to 70.8)
    25.0 (3.2 to 65.1)
    50.0 (18.7 to 81.3)
    20.0 (2.5 to 55.6)
    Notes
    [1] - Full analysis set (FAS) included all randomized subjects.
    [2] - FAS with evaluable subjects for this end point.
    [3] - FAS
    [4] - FAS with evaluable subjects for this end point.
    [5] - FAS with evaluable subjects for this end point.
    Statistical analysis title
    		 Statistical analysis 1: NSCLC
    Comparison groups
    Non-Small Cell Lung Cancer (NSCLC): CAP7.1 v Non-Small Cell Lung Cancer (NSCLC): Best Supportive Care (BSC)
    Number of subjects included in analysis
    7
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.286
    Method
    		 t-test, 1-sided
    Parameter type
    		 Treatment difference
    Point estimate
    50
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -30.14
         upper limit
    		 93.24
    Statistical analysis title
    		 Statistical analysis 2: Biliary
    Comparison groups
    Biliary tract cancer: CAP7.1 v Biliary tract cancer: Best Supportive Care (BSC)
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.175
    Method
    		 t-test, 1-sided
    Parameter type
    		 Treatment difference
    Point estimate
    30
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -18.44
         upper limit
    		 69.22

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of study drug administration until 6 months post-therapy discontinuation/death
    Adverse event reporting additional description
    The reporting groups "Biliary tract cancer: BSC before cross-over to CAP7.1" and "Biliary tract cancer: CAP7.1 after Best Supportive Care" were not mutually exclusive for the representation of adverse events.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0E
    Reporting groups
    Reporting group title
    Non-Small Cell Lung Cancer (NSCLC): CAP7.1
    Reporting group description
    		 Subjects with NSCLC who had progressed despite previous therapies received 60 minutes (min) intravenous infusion of 150 or 200 milligram per square meter (mg/m^2) CAP7.1 daily for 5 consecutive days, followed by a medication free interval of 23 days. The full 28-day treatment cycle (5 days on treatment and 23-day treatment-free interval) was repeated until disease progression, unmanageable toxicity or withdrawal of consent (whichever occurred first), if recovery from haematological and other toxicities was considered adequate.

    Reporting group title
    Non-Small Cell Lung Cancer (NSCLC): Best Supportive Care
    Reporting group description
    		 Subjects with NSCLC who had progressed despite previous therapies received best support as per institutional standards. In case of progression, these subjects were allowed to cross over to CAP7.1 therapy at the dose of 150 or 200 mg/m^2 (60 min intravenous infusion) daily for 5 consecutive days, followed by a medication free interval of 23 days. The full 28-day treatment cycle (5 days on treatment and 23-day treatment-free interval) was repeated until disease progression, unmanageable toxicity or withdrawal of consent (whichever occurred first), if recovery from haematological and other toxicities was considered adequate.

    Reporting group title
    Small Cell Lung Cancer (SCLC): CAP7.1
    Reporting group description
    		 Subjects with SCLC who had progressed despite previous therapies received 60 min intravenous infusion of 150 or 200 mg/m^2 CAP7.1 daily for 5 consecutive days, followed by a medication free interval of 23 days. The full 28-day treatment cycle (5 days on treatment and 23-day treatment-free interval) was repeated until disease progression, unmanageable toxicity or withdrawal of consent (whichever occurred first), if recovery from haematological and other toxicities was considered adequate.

    Reporting group title
    Biliary tract cancer: CAP7.1
    Reporting group description
    		 Subjects with advanced biliary tract cancer who had progressed despite previous therapies received 60 min intravenous infusion of 150 or 200 mg/m^2 CAP7.1 daily for 5 consecutive days, followed by a medication free interval of 23 days. The full 28-day treatment cycle (5 days on treatment and 23-day treatment-free interval) was repeated until disease progression, unmanageable toxicity or withdrawal of consent (whichever occurred first), if recovery from haematological and other toxicities was considered adequate.

    Reporting group title
    Biliary tract cancer: BSC before cross-over to CAP7.1
    Reporting group description
    		 Subjects with advanced biliary tract cancer who had progressed despite previous therapies received best support as per institutional standards. In case of progression, these subjects were allowed to cross over to CAP7.1 therapy at the dose of 150 or 200 mg/m^2 (60 min intravenous infusion) daily for 5 consecutive days, followed by a medication free interval of 23 days. The full 28-day treatment cycle (5 days on treatment and 23-day treatment-free interval) was repeated until disease progression, unmanageable toxicity or withdrawal of consent (whichever occurred first), if recovery from haematological and other toxicities was considered adequate.

    Reporting group title
    Biliary tract cancer: CAP7.1 after Best Supportive Care
    Reporting group description
    		 Subjects with advanced biliary tract cancer who had progressed despite previous therapies received best support as per institutional standards. In case of progression, these subjects were allowed to cross over to CAP7.1 therapy at the dose of 150 or 200 mg/m^2 (60 min intravenous infusion) daily for 5 consecutive days, followed by a medication free interval of 23 days. The full 28-day treatment cycle (5 days on treatment and 23-day treatment-free interval) was repeated until disease progression, unmanageable toxicity or withdrawal of consent (whichever occurred first), if recovery from haematological and other toxicities was considered adequate.

    Serious adverse events
    		 Non-Small Cell Lung Cancer (NSCLC): CAP7.1 Non-Small Cell Lung Cancer (NSCLC): Best Supportive Care Small Cell Lung Cancer (SCLC): CAP7.1 Biliary tract cancer: CAP7.1 Biliary tract cancer: BSC before cross-over to CAP7.1 Biliary tract cancer: CAP7.1 after Best Supportive Care
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 4 (50.00%)
    1 / 2 (50.00%)
    6 / 8 (75.00%)
    7 / 13 (53.85%)
    2 / 10 (20.00%)
    8 / 10 (80.00%)
         number of deaths (all causes)
    4
    2
    8
    12
    0
    10
         number of deaths resulting from adverse events
    1
    0
    2
    4
    0
    4
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant neoplasm progression
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    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 / 1
    Cardiac arrest
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematotoxicity
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    2 / 13 (15.38%)
    0 / 10 (0.00%)
    3 / 10 (30.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    3 / 3
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    2 / 10 (20.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Condition aggravated
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Death
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device occlusion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Disease progression
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 8 (25.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 1
    General physical health deterioration
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Infusion site anaesthesia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    1 / 10 (10.00%)
    2 / 10 (20.00%)
         occurrences causally related to treatment / all
    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
    Ascites
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    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
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    1 / 10 (10.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    1 / 10 (10.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal impairment
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    Febrile infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    Urinary tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    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
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Tumour lysis syndrome
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Non-Small Cell Lung Cancer (NSCLC): CAP7.1 Non-Small Cell Lung Cancer (NSCLC): Best Supportive Care Small Cell Lung Cancer (SCLC): CAP7.1 Biliary tract cancer: CAP7.1 Biliary tract cancer: BSC before cross-over to CAP7.1 Biliary tract cancer: CAP7.1 after Best Supportive Care
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 4 (100.00%)
    1 / 2 (50.00%)
    8 / 8 (100.00%)
    13 / 13 (100.00%)
    8 / 10 (80.00%)
    10 / 10 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    Hypertensive crisis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Hypotension
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Microangiopathy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Surgical and medical procedures
    Central venous catheter removal
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Resuscitation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    1 / 10 (10.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    1
    1
    Chest discomfort
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Chest pain
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 2 (0.00%)
    2 / 8 (25.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    2
    0
    2
    1
    0
    1
    Chills
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    2 / 13 (15.38%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    2
    0
    1
    Fatigue
         subjects affected / exposed
    3 / 4 (75.00%)
    0 / 2 (0.00%)
    5 / 8 (62.50%)
    4 / 13 (30.77%)
    0 / 10 (0.00%)
    4 / 10 (40.00%)
         occurrences all number
    4
    0
    7
    6
    0
    4
    Feeling abnormal
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    General physical health deterioration
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Inflammation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Infusion site anaesthesia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Infusion site extravasation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Mucosal inflammation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    1
    0
    1
    Oedema
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    2 / 13 (15.38%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    2
    0
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    0
    0
    1
    0
    3
    Pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    2 / 13 (15.38%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    0
    Pyrexia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    1 / 10 (10.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    0
    1
    1
    1
    Spinal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Reproductive system and breast disorders
    Breast swelling
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Pruritus genital
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 8 (25.00%)
    2 / 13 (15.38%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    2
    2
    1
    0
    Dyspnoea
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    5 / 8 (62.50%)
    2 / 13 (15.38%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    5
    2
    0
    1
    Epistaxis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    1 / 10 (10.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Pharyngeal oedema
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Pleural effusion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Pulmonary embolism
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Depression
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Insomnia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    1
    0
    1
    Panic attack
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Stress
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Investigations
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    C-reactive protein increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Carbohydrate antigen 19-9 increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Carcinoembryonic antigen increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Coagulation time prolonged
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Eastern Cooperative Oncology Group performance status
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Eastern Cooperative Oncology Group performance status worsened
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 2 (50.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Weight decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    Scratch
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Cardiac disorders
    Arrhythmia supraventricular
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Atrial fibrillation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Bradycardia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Dizziness
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    1 / 10 (10.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    0
    0
    1
    1
    2
    Facial paresis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Headache
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    2
    0
    1
    Neuralgia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Paraesthesia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Tremor
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 4 (75.00%)
    0 / 2 (0.00%)
    3 / 8 (37.50%)
    7 / 13 (53.85%)
    1 / 10 (10.00%)
    5 / 10 (50.00%)
         occurrences all number
    3
    0
    4
    20
    1
    13
    Bicytopenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Eosinophilia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Febrile neutropenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    2 / 13 (15.38%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    Leukocytosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Leukopenia
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 2 (0.00%)
    4 / 8 (50.00%)
    10 / 13 (76.92%)
    0 / 10 (0.00%)
    5 / 10 (50.00%)
         occurrences all number
    2
    0
    7
    25
    0
    7
    Lymphopenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Monocytopenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Neutropenia
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    7 / 13 (53.85%)
    0 / 10 (0.00%)
    7 / 10 (70.00%)
         occurrences all number
    2
    0
    1
    17
    0
    13
    Reticulocytopenia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Thrombocytopenia
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    7 / 13 (53.85%)
    0 / 10 (0.00%)
    5 / 10 (50.00%)
         occurrences all number
    1
    0
    0
    21
    0
    7
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    0
    0
    1
    0
    2
    Eye disorders
    Eye irritation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Ocular icterus
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Visual impairment
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Abdominal pain
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    4 / 13 (30.77%)
    2 / 10 (20.00%)
    1 / 10 (10.00%)
         occurrences all number
    1
    0
    0
    5
    2
    1
    Abdominal pain upper
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    2 / 13 (15.38%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    3
    0
    1
    Ascites
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    0
    0
    1
    0
    2
    Breath odour
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Cheilitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Constipation
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    3 / 8 (37.50%)
    2 / 13 (15.38%)
    0 / 10 (0.00%)
    4 / 10 (40.00%)
         occurrences all number
    1
    0
    5
    2
    0
    4
    Diarrhoea
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    3 / 8 (37.50%)
    5 / 13 (38.46%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    3
    5
    0
    1
    Dysphagia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Flatulence
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    2 / 13 (15.38%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    2
    1
    0
    Hypoaesthesia oral
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Nausea
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 2 (0.00%)
    4 / 8 (50.00%)
    4 / 13 (30.77%)
    1 / 10 (10.00%)
    2 / 10 (20.00%)
         occurrences all number
    2
    0
    6
    6
    1
    2
    Stomatitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Vomiting
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    1 / 13 (7.69%)
    1 / 10 (10.00%)
    2 / 10 (20.00%)
         occurrences all number
    1
    0
    2
    1
    1
    2
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Hepatic pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    2 / 13 (15.38%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    3
    0
    1
    Hypertransaminasaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    2 / 13 (15.38%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    5
    0
    0
    Jaundice
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    2 / 8 (25.00%)
    4 / 13 (30.77%)
    0 / 10 (0.00%)
    4 / 10 (40.00%)
         occurrences all number
    0
    0
    2
    4
    0
    4
    Alopecia totalis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Decubitus ulcer
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Dry skin
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Erythema
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    Night sweats
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    Pruritus
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    Pruritus generalised
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Rash
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    1 / 10 (10.00%)
    3 / 10 (30.00%)
         occurrences all number
    0
    0
    0
    0
    1
    4
    Rash pruritic
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Skin fissures
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Skin hyperpigmentation
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Skin lesion
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Leukocyturia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Proteinuria
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Renal failure acute
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Renal impairment
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    1 / 10 (10.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    1
    2
    Back pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Bone pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Bursitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Flank pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Muscle spasms
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    2
    0
    0
    1
    Muscle twitching
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Myalgia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    3 / 8 (37.50%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    5
    0
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Infections and infestations
    Administration site infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Candidiasis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    Oral candidiasis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Oral fungal infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Periodontitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Pharyngitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Pneumonia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Sepsis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    0 / 13 (0.00%)
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Vulvitis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 4 (50.00%)
    0 / 2 (0.00%)
    5 / 8 (62.50%)
    3 / 13 (23.08%)
    1 / 10 (10.00%)
    1 / 10 (10.00%)
         occurrences all number
    2
    0
    8
    3
    1
    1
    Hyperkalaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Hyperphosphataemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Hyperphosphatasaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    2 / 10 (20.00%)
         occurrences all number
    0
    0
    0
    1
    0
    2
    Hyperuricaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    1 / 8 (12.50%)
    0 / 13 (0.00%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Hypocalcaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Hyponatraemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 2 (0.00%)
    0 / 8 (0.00%)
    1 / 13 (7.69%)
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Nov 2013
    - Tissue sampling with MRT and Ultrasound was added. - Dose adjustment
    27 Feb 2014
    - MRT removed

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was terminated to be redesigned for a trial according to EMA proposal.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28531881
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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