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    Clinical Trial Results:
    A randomized, open-label, two-arm phase II trial comparing the efficacy of sequential Ipilimumab versus best supportive care following first-line chemotherapy in subjects with unresectable locally advanced/metastatic gastric or gastro-esophageal junction cancer

    Summary
    EudraCT number
    		 2011-000853-22
    Trial protocol
    		 ES   DE   IT  
    Global end of trial date
    02 Apr 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 May 2016
    First version publication date
    22 May 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CA184-162
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01585987
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussee de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, clinical.trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, clinical.trials@bms.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Apr 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the study is to compare the efficacy of Ipilimumab and standard of care as sequential or maintenance treatment immediately after first-line chemotherapy in the treatment of unresectable or metastatic gastric and gastro-esophageal cancer.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Jul 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 9
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Hong Kong: 1
    Country: Number of subjects enrolled
    Italy: 27
    Country: Number of subjects enrolled
    Japan: 12
    Country: Number of subjects enrolled
    Korea, Republic of: 53
    Country: Number of subjects enrolled
    Poland: 2
    Country: Number of subjects enrolled
    Russian Federation: 3
    Country: Number of subjects enrolled
    Singapore: 3
    Country: Number of subjects enrolled
    Spain: 12
    Country: Number of subjects enrolled
    Taiwan: 3
    Country: Number of subjects enrolled
    United States: 16
    Worldwide total number of subjects
    143
    EEA total number of subjects
    52
    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)
    79
    From 65 to 84 years
    63
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 31 centres in 12 countries.

    Pre-assignment
    Screening details
    		 A total of 143 subjects were enrolled in the study, out of which 114 were randomized. 29 subjects were not randomised due to: 26 no longer met study criteria; 2 withdrew consent, 1 other reason.

    Period 1
    Period 1 title
    Randomised
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ipilimumab
    Arm description
    		 Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ipilimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ipilimumab 10 mg/kg of body weight was administered intravenously, over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression.

    Arm title
    		 All Best Supportive care (BSC)
    Arm description
    		 All BSC includes both active and non-active BSC. Active BSC includes the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomisation to this study), but no other active systemic anti-cancer treatment. In non-active BSC, the fluoropyrimidine used during lead-in chemotherapy was not continued on study and no other chemotherapy or active treatment was used
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Capecitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Continuation of Capecitabine dose used during the lead-in chemotherapy, administered orally as per standard of care until disease progression or toxicity.

    Investigational medicinal product name
    5-Fluorouracil (5-FU)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Continuation of 5-FU dose used during the lead-in chemotherapy, administered intravenously as per standard of care until disease progression or toxicity.

    Investigational medicinal product name
    Tegafur/Gimeracil/Oteracil potassium or S-1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Continuation of S-1 dose used during the lead-in chemotherapy, administered orally as per standard of care until disease progression or toxicity.

    Number of subjects in period 1 [1]
    		Ipilimumab All Best Supportive care (BSC)
    Started
    57
    57
    Completed
    57
    51
    Not completed
    0
    6
         Consent withdrawn by subject
    -
    4
         No longer met criteria
    -
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Out of 143 subjects who were enrolled in the study, 114 were randomised. 29 subjects were not randomised due to: 26 no longer met study criteria; 2 withdrew consent, 1 other reason.
    Period 2
    Period 2 title
    Treated
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ipilimumab
    Arm description
    		 Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ipilimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ipilimumab 10 mg/kg of body weight was administered intravenously, over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression.

    Arm title
    		 All Best Supportive care (BSC)
    Arm description
    		 All BSC includes both active and non-active BSC. Active BSC includes the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomisation to this study), but no other active systemic anti-cancer treatment. In non-active BSC, the fluoropyrimidine used during lead-in chemotherapy was not continued on study and no other chemotherapy or active treatment was used.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Capecitabine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Continuation of Capecitabine dose used during the lead-in chemotherapy, administered orally as per standard of care until disease progression or toxicity.

    Investigational medicinal product name
    5-Fluorouracil (5-FU)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Continuation of 5-FU dose used during the lead-in chemotherapy, administered intravenously as per standard of care until disease progression or toxicity.

    Investigational medicinal product name
    Tegafur/Gimeracil/Oteracil potassium or S-1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Continuation of S-1 dose used during the lead-in chemotherapy, administered orally as per standard of care until disease progression or toxicity.

    Number of subjects in period 2
    		Ipilimumab All Best Supportive care (BSC)
    Started
    57
    51
    Completed
    3
    2
    Not completed
    54
    49
         Adverse event, serious fatal
    1
    -
         Non-Specified
    1
    2
         Consent withdrawn by subject
    1
    2
         Poor/Non-Compliance
    -
    1
         Adverse event, non-fatal
    3
    -
         Maximum Clinical Benefit
    -
    1
         Study Drug Toxicity
    9
    5
         Lost to follow-up
    -
    1
         Subject Request
    -
    1
         Disease Progression
    39
    36

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ipilimumab
    Reporting group description
    		 Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.

    Reporting group title
    All Best Supportive care (BSC)
    Reporting group description
    		 All BSC includes both active and non-active BSC. Active BSC includes the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomisation to this study), but no other active systemic anti-cancer treatment. In non-active BSC, the fluoropyrimidine used during lead-in chemotherapy was not continued on study and no other chemotherapy or active treatment was used

    Reporting group values
    		 Ipilimumab All Best Supportive care (BSC) Total
    Number of subjects
    		 57 57 114
    Age, Customized
    Units: subjects
        Less than (<) 65 years of age
    		 28 35 63
        Greater, equal to (>=) 65 years of age
    		 29 22 51
    Age Continuous
    Units: years
        median (full range (min-max))
    		 65 (34 to 86) 62 (32 to 80) -
    Gender, Male/Female
    Units: subjects
        Female
    		 21 16 37
        Male
    		 36 41 77
    Region of Enrollment
    Units: Subjects
        Russian Federation
    		 1 1 2
        Singapore
    		 1 1 2
        Hong Kong
    		 1 0 1
        United States
    		 8 6 14
        Japan
    		 7 5 12
        Taiwan
    		 1 0 1
        Poland
    		 0 2 2
        Korea, Republic of
    		 21 24 45
        Italy
    		 11 8 19
        France
    		 3 5 8
        Germany
    		 1 0 1
        Spain
    		 2 5 7

    End points

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    End points reporting groups
    Reporting group title
    Ipilimumab
    Reporting group description
    		 Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.

    Reporting group title
    All Best Supportive care (BSC)
    Reporting group description
    		 All BSC includes both active and non-active BSC. Active BSC includes the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomisation to this study), but no other active systemic anti-cancer treatment. In non-active BSC, the fluoropyrimidine used during lead-in chemotherapy was not continued on study and no other chemotherapy or active treatment was used
    Reporting group title
    Ipilimumab
    Reporting group description
    		 Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.

    Reporting group title
    All Best Supportive care (BSC)
    Reporting group description
    		 All BSC includes both active and non-active BSC. Active BSC includes the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomisation to this study), but no other active systemic anti-cancer treatment. In non-active BSC, the fluoropyrimidine used during lead-in chemotherapy was not continued on study and no other chemotherapy or active treatment was used.

    Primary: Immune-related Progression Free Survival (irPFS) as Per Assessment of a Blinded Independent Review Committee (IRC) According to Immune Related Response Criteria (irRC) Guidelines

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    End point title
    		 Immune-related Progression Free Survival (irPFS) as Per Assessment of a Blinded Independent Review Committee (IRC) According to Immune Related Response Criteria (irRC) Guidelines
    End point description
    irPFS is defined as the time between the randomisation date and the time of disease progression per irRC or death, whichever occurs first. irRC criteria=Measurable new lesions: incorporated into the tumor burden (eg, added to the index lesions); do not define progression unless the total measurable tumor burden increases by the required amount (25%). New non-measurable lesions: not considered progression if the total measurable tumor burden is stable or shrinking. irPFS was measured in months. The analysis was performed in all the subjects who were randomised.
    End point type
    Primary
    End point timeframe
    Randomisation up to 91 irPFS events (Approximately 19 months )
    End point values
    		 Ipilimumab All Best Supportive care (BSC)
    Number of subjects analysed
    57
    57
    Units: Months
        median (confidence interval 95%)
    2.924 (1.61 to 5.158)
    4.895 (3.45 to 6.538)
    Statistical analysis title
    		 irPFS as per assessment of blinded IRC
    Comparison groups
    All Best Supportive care (BSC) v Ipilimumab
    Number of subjects included in analysis
    114
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0972 [1]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.439
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 1.085
         upper limit
    		 1.908
    Notes
    [1] - Significance level used: 0.2

    Secondary: Progression Free Survival (PFS) Per Modified World Health Organization (mWHO) Criteria

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    End point title
    		 Progression Free Survival (PFS) Per Modified World Health Organization (mWHO) Criteria
    End point description
    PFS per mWHO was defined as the time between the randomisation date and the time of disease progression per mWHO criteria or death, whichever occurred first and was measured in months. mWHO criteria: New lesions always mean progression; Changes in non-measurable lesions contribute in the definitions of Complete Response (CR), Partial Response (PR), Stable Disease (SD) and Progressive Disease (PD). The analysis was performed in all the subjects who were randomised.
    End point type
    Secondary
    End point timeframe
    Randomisation up to 91 irPFS events (Approximately 19 months )
    End point values
    		 Ipilimumab All Best Supportive care (BSC)
    Number of subjects analysed
    57
    57
    Units: Months
        median (confidence interval 95%)
    2.727 (1.446 to 2.957)
    4.895 (3.45 to 6.078)
    No statistical analyses for this end point

    Secondary: Overall survival (OS)

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    End point title
    		 Overall survival (OS)
    End point description
    OS was defined as the time from the date of randomisation until the date of death. For those subjects who have not died, OS was censored on the last date the subject was known to be alive. Here, 99999 signifies data not estimable since the largest observation was censored.
    End point type
    Secondary
    End point timeframe
    Randomisation up to end of study, April 2015 (Approximately 28 months)
    End point values
    		 Ipilimumab All Best Supportive care (BSC)
    Number of subjects analysed
    57
    51
    Units: Months
        median (confidence interval 95%)
    12.68 (10.51 to 18.92)
    12.06 (9.33 to 99999)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Immune-Related Best Overall Response (irBOR)

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    End point title
    		 Percentage of Subjects With Immune-Related Best Overall Response (irBOR)
    End point description
    IrBOR rate was defined as the number of subjects whose Immune-related Best Overall Response (irBOR) criteria was Immune-related Complete Response (irCR) or Immune-related Partial Response (irPR), divided by the total number of subjects. The immune-related sum of products of diameters (irSPD) incorporates - in addition to the index lesions - measurable new lesions that may have developed on-study, providing an assessment that includes both index and new lesions. irCR=Complete disappearance of all tumor lesions (both index and non-index lesions with no new measurable/unmeasurable lesions). irPR=A 50% or greater decrease, relative to baseline of the irSPD, (based on irSPD of all index lesions and any measurable new lesions). The analysis was performed in all the subjects who were randomised.
    End point type
    Secondary
    End point timeframe
    Randomisation up to 91 irPFS events (Approximately 19 months)
    End point values
    		 Ipilimumab All Best Supportive care (BSC)
    Number of subjects analysed
    57
    57
    Units: percentage of subjects
        number (not applicable)
    1.8
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 of study treatment up to 90 days after the last dose of the study drug
    Adverse event reporting additional description
    Study initiated: July 2012; End of Study: April 2015
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Ipilimumab
    Reporting group description
    		 Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.

    Reporting group title
    Active Best Supportive Care (BSC)
    Reporting group description
    		 Active BSC includes the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomisation)

    Reporting group title
    Non-Active BSC
    Reporting group description
    		 Non-Active BSC involves supportive care with cessation of chemotherapy (no active drug).

    Serious adverse events
    		 Ipilimumab Active Best Supportive Care (BSC) Non-Active BSC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    31 / 57 (54.39%)
    19 / 45 (42.22%)
    1 / 6 (16.67%)
         number of deaths (all causes)
    25
    24
    3
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung neoplasm malignant
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastatic gastric cancer
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Malignant neoplasm progression
         subjects affected / exposed
    0 / 57 (0.00%)
    2 / 45 (4.44%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    Gastrointestinal cancer metastatic
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypothermia
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Performance status decreased
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Disease progression
         subjects affected / exposed
    6 / 57 (10.53%)
    4 / 45 (8.89%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 57 (1.75%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Malaise
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    3 / 57 (5.26%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 57 (0.00%)
    2 / 45 (4.44%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Transaminases increased
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Compression fracture
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 57 (1.75%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 57 (5.26%)
    2 / 45 (4.44%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 57 (1.75%)
    4 / 45 (8.89%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 57 (1.75%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Large intestinal obstruction
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Obstruction gastric
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Dyspepsia
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 57 (3.51%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    3 / 57 (5.26%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    7 / 57 (12.28%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    7 / 9
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystocholangitis
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatitis acute
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Hypopituitarism
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypothyroidism
         subjects affected / exposed
    2 / 57 (3.51%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorder
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    2 / 57 (3.51%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    4 / 57 (7.02%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal infection
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    7 / 57 (12.28%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    2 / 57 (3.51%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ipilimumab Active Best Supportive Care (BSC) Non-Active BSC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    55 / 57 (96.49%)
    42 / 45 (93.33%)
    4 / 6 (66.67%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 57 (3.51%)
    2 / 45 (4.44%)
    1 / 6 (16.67%)
         occurrences all number
    2
    2
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    9 / 57 (15.79%)
    7 / 45 (15.56%)
    0 / 6 (0.00%)
         occurrences all number
    16
    9
    0
    Pain
         subjects affected / exposed
    3 / 57 (5.26%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    0
    Influenza like illness
         subjects affected / exposed
    0 / 57 (0.00%)
    3 / 45 (6.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    3
    0
    Asthenia
         subjects affected / exposed
    12 / 57 (21.05%)
    7 / 45 (15.56%)
    0 / 6 (0.00%)
         occurrences all number
    15
    10
    0
    Chest pain
         subjects affected / exposed
    3 / 57 (5.26%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences all number
    3
    1
    0
    Chills
         subjects affected / exposed
    3 / 57 (5.26%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences all number
    7
    1
    0
    Oedema peripheral
         subjects affected / exposed
    8 / 57 (14.04%)
    5 / 45 (11.11%)
    0 / 6 (0.00%)
         occurrences all number
    9
    5
    0
    Fatigue
         subjects affected / exposed
    26 / 57 (45.61%)
    9 / 45 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    28
    9
    0
    Mucosal inflammation
         subjects affected / exposed
    0 / 57 (0.00%)
    4 / 45 (8.89%)
    0 / 6 (0.00%)
         occurrences all number
    0
    4
    0
    Respiratory, thoracic and mediastinal disorders
    Hiccups
         subjects affected / exposed
    1 / 57 (1.75%)
    4 / 45 (8.89%)
    0 / 6 (0.00%)
         occurrences all number
    1
    4
    0
    Productive cough
         subjects affected / exposed
    3 / 57 (5.26%)
    2 / 45 (4.44%)
    0 / 6 (0.00%)
         occurrences all number
    3
    3
    0
    Dyspnoea
         subjects affected / exposed
    6 / 57 (10.53%)
    5 / 45 (11.11%)
    0 / 6 (0.00%)
         occurrences all number
    6
    5
    0
    Upper respiratory tract inflammation
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 45 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Cough
         subjects affected / exposed
    5 / 57 (8.77%)
    6 / 45 (13.33%)
    0 / 6 (0.00%)
         occurrences all number
    7
    6
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 57 (0.00%)
    4 / 45 (8.89%)
    0 / 6 (0.00%)
         occurrences all number
    0
    4
    0
    Insomnia
         subjects affected / exposed
    5 / 57 (8.77%)
    6 / 45 (13.33%)
    0 / 6 (0.00%)
         occurrences all number
    6
    6
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    9 / 57 (15.79%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences all number
    10
    1
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    9 / 57 (15.79%)
    2 / 45 (4.44%)
    0 / 6 (0.00%)
         occurrences all number
    11
    2
    0
    Weight decreased
         subjects affected / exposed
    11 / 57 (19.30%)
    5 / 45 (11.11%)
    0 / 6 (0.00%)
         occurrences all number
    11
    5
    0
    Haemoglobin decreased
         subjects affected / exposed
    3 / 57 (5.26%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences all number
    3
    2
    0
    Weight increased
         subjects affected / exposed
    3 / 57 (5.26%)
    1 / 45 (2.22%)
    1 / 6 (16.67%)
         occurrences all number
    3
    1
    1
    Injury, poisoning and procedural complications
    Laceration
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    5 / 57 (8.77%)
    2 / 45 (4.44%)
    0 / 6 (0.00%)
         occurrences all number
    5
    2
    0
    Peripheral sensory neuropathy
         subjects affected / exposed
    6 / 57 (10.53%)
    1 / 45 (2.22%)
    1 / 6 (16.67%)
         occurrences all number
    7
    1
    1
    Headache
         subjects affected / exposed
    4 / 57 (7.02%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences all number
    5
    1
    0
    Neuropathy peripheral
         subjects affected / exposed
    10 / 57 (17.54%)
    7 / 45 (15.56%)
    0 / 6 (0.00%)
         occurrences all number
    10
    7
    0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    2 / 57 (3.51%)
    7 / 45 (15.56%)
    0 / 6 (0.00%)
         occurrences all number
    2
    7
    0
    Anaemia
         subjects affected / exposed
    12 / 57 (21.05%)
    5 / 45 (11.11%)
    0 / 6 (0.00%)
         occurrences all number
    16
    8
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    12 / 57 (21.05%)
    16 / 45 (35.56%)
    0 / 6 (0.00%)
         occurrences all number
    14
    18
    0
    Dysphagia
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 45 (2.22%)
    2 / 6 (33.33%)
         occurrences all number
    0
    1
    2
    Abdominal pain upper
         subjects affected / exposed
    6 / 57 (10.53%)
    4 / 45 (8.89%)
    0 / 6 (0.00%)
         occurrences all number
    7
    4
    0
    Constipation
         subjects affected / exposed
    10 / 57 (17.54%)
    12 / 45 (26.67%)
    0 / 6 (0.00%)
         occurrences all number
    11
    13
    0
    Dyspepsia
         subjects affected / exposed
    5 / 57 (8.77%)
    3 / 45 (6.67%)
    0 / 6 (0.00%)
         occurrences all number
    5
    4
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    3 / 57 (5.26%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    0
    Nausea
         subjects affected / exposed
    19 / 57 (33.33%)
    16 / 45 (35.56%)
    0 / 6 (0.00%)
         occurrences all number
    29
    18
    0
    Vomiting
         subjects affected / exposed
    17 / 57 (29.82%)
    12 / 45 (26.67%)
    0 / 6 (0.00%)
         occurrences all number
    24
    10
    0
    Abdominal distension
         subjects affected / exposed
    3 / 57 (5.26%)
    2 / 45 (4.44%)
    0 / 6 (0.00%)
         occurrences all number
    3
    2
    0
    Diarrhoea
         subjects affected / exposed
    19 / 57 (33.33%)
    9 / 45 (20.00%)
    0 / 6 (0.00%)
         occurrences all number
    36
    12
    0
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 45 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Palmar-plantar erythrodysaesthesia syndrome
         subjects affected / exposed
    4 / 57 (7.02%)
    8 / 45 (17.78%)
    0 / 6 (0.00%)
         occurrences all number
    3
    16
    0
    Pruritus
         subjects affected / exposed
    25 / 57 (43.86%)
    3 / 45 (6.67%)
    0 / 6 (0.00%)
         occurrences all number
    31
    3
    0
    Rash
         subjects affected / exposed
    15 / 57 (26.32%)
    2 / 45 (4.44%)
    1 / 6 (16.67%)
         occurrences all number
    18
    2
    1
    Dry skin
         subjects affected / exposed
    3 / 57 (5.26%)
    2 / 45 (4.44%)
    0 / 6 (0.00%)
         occurrences all number
    3
    2
    0
    Alopecia
         subjects affected / exposed
    3 / 57 (5.26%)
    2 / 45 (4.44%)
    0 / 6 (0.00%)
         occurrences all number
    3
    2
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    4 / 57 (7.02%)
    0 / 45 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    5
    0
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    4 / 57 (7.02%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences all number
    9
    2
    0
    Arthralgia
         subjects affected / exposed
    3 / 57 (5.26%)
    4 / 45 (8.89%)
    0 / 6 (0.00%)
         occurrences all number
    4
    6
    0
    Back pain
         subjects affected / exposed
    6 / 57 (10.53%)
    3 / 45 (6.67%)
    0 / 6 (0.00%)
         occurrences all number
    7
    3
    0
    Bone pain
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 45 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    Pain in extremity
         subjects affected / exposed
    2 / 57 (3.51%)
    2 / 45 (4.44%)
    1 / 6 (16.67%)
         occurrences all number
    2
    2
    1
    Neck pain
         subjects affected / exposed
    2 / 57 (3.51%)
    0 / 45 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    2
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    21 / 57 (36.84%)
    14 / 45 (31.11%)
    0 / 6 (0.00%)
         occurrences all number
    24
    15
    0
    Hypokalaemia
         subjects affected / exposed
    8 / 57 (14.04%)
    2 / 45 (4.44%)
    0 / 6 (0.00%)
         occurrences all number
    9
    2
    0
    Hyponatraemia
         subjects affected / exposed
    3 / 57 (5.26%)
    1 / 45 (2.22%)
    0 / 6 (0.00%)
         occurrences all number
    4
    2
    0
    Hypoalbuminaemia
         subjects affected / exposed
    5 / 57 (8.77%)
    5 / 45 (11.11%)
    0 / 6 (0.00%)
         occurrences all number
    6
    5
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Jul 2012
    The main purpose of the amendment was: • To modify the acceptable lead-in chemotherapy to allow a larger Japanese patient population to be included; • To add/clarify information on the women of Childbearing Potential (WOCBP) as per the most recent BMS policy; • To add specific language for immune-mediated Adverse Reactions; • To remove the mandatory bone scans; • Other administrative changes.
    31 Jan 2013
    The main purpose of the amendment was: • To allow subjects with a platelet count between 100,000 and 75,000 to enter the trial; • To add an additional acceptable lead-in chemotherapy • To add/clarify information on the definition of WOCBP; • Other minor changes to correct and/or clarify protocol requirements; • The amendment was applicable to all subjects; • The amendment will not impact data analysis.
    08 May 2013
    The main purpose of the amendment was: • To modify the requirement for local lab Free T3 and T4 testing at Screening from required to obtained if available, otherwise Total T3 and T4 testing is acceptable. • To allow Magnetic resonance imaging of the chest and remove the requirement for using the same scanner. • To remove the stipulation of not carrying out the interim analysis in case the timing of the interim analysis is within 6 months of the planned date of the primary analysis. • Other minor changes to correct and/or clarify protocol requirements.
    28 Mar 2014
    The main purpose of the amendment was to limit dosing of ipilimumab in the study to 3 years. The guidance for WOCBP was also clarified as per the most recent BMS policy. Other minor changes to correct and/or clarify protocol requirements.

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

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