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    Clinical Trial Results:
    A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Amatuximab in Combination with Pemetrexed and Cisplatin in Subjects with Unresectable Malignant Pleural Mesothelioma

    Summary
    EudraCT number
    		 2014-004489-85
    Trial protocol
    		 DE   IT  
    Global end of trial date
    30 Nov 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Apr 2020
    First version publication date
    03 Apr 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MORAb-009-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02357147
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Morphotek (a subsidiary of Eisai Inc.)
    Sponsor organisation address
    155 Tice Boulevard, Woodcliff Lake, New Jersey, United States, 07677
    Public contact
    EISAI Medical Information, Eisai Ltd., +1 888-274-2378, esi_oncmedinfo@eisai.com
    Scientific contact
    EISAI Medical Information, Eisai Ltd., +1 888-274-2378, esi_oncmedinfo@eisai.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Nov 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Nov 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to provide ongoing amatuximab treatment access consistent with the original MORAb-009-201 treatment schedule to those subjects randomized to the amatuximab arm who, at the discretion of their investigator, may obtain ongoing clinical benefit.
    Protection of trial subjects
    This study was conducted in accordance with standard operating procedures (SOPs) of the sponsor (or designee), which are designed to ensure adherence to Good Clinical Practice (GCP) guidelines as required by the following: - Principles of the World Medical Association Declaration of Helsinki (World Medical Association, 2008) - International Council on Harmonisation (ICH) E6 Guideline for GCP (CPMP/ICH/135/95) of the European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products, International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use -Title 21 of the United States (US) Code of Federal Regulations (US 21 CFR) regarding clinical studies, including Part 50 and Part 56 concerning informed subject consent and Institutional Review Board (IRB) regulations and applicable sections of US 21 CFR Part 312 - European Good Clinical Practice Directive 2005/28/EC and Clinical Trial Directive 2001/20/EC for studies conducted within any European Union (EU) country. All suspected unexpected serious adverse reactions were reported, as required, to the Competent Authorities of all involved EU member states. -Article 14, Paragraph 3, and Article 80-2 of the Pharmaceutical Affairs Law (Law No. 145, 1960) for studies conducted in Japan, in addition to Japan’s GCP Subject Information and Informed Consent.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Nov 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 7
    Country: Number of subjects enrolled
    Australia: 3
    Country: Number of subjects enrolled
    United Kingdom: 19
    Country: Number of subjects enrolled
    France: 20
    Country: Number of subjects enrolled
    Germany: 14
    Country: Number of subjects enrolled
    Italy: 43
    Worldwide total number of subjects
    106
    EEA total number of subjects
    96
    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)
    33
    From 65 to 84 years
    72
    85 years and over
    1

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Subjects took part in the study at 36 investigative sites in the United States, France, Germany, Italy, the United Kingdom, and Australia from 03 November 2015 to 30 November 2018.

    Pre-assignment
    Screening details
    		 A total of 124 subjects were enrolled (signed informed consent form), of which, 16 were screen failures, 108 were randomized, and 106 were treated. Deaths that were primary cause of treatment discontinuation are reported in subject flow excluding those that occurred after treatment discontinuation.

    Period 1
    Period 1 title
    Combination Treatment Phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Amatuximab + Pemetrexed + Cisplatin
    Arm description
    		 During combination treatment phase, subjects received amatuximab 5 milligram per kilogram (mg/kg), infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 milligram per square meter (mg/m^2) and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, subjects who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Amatuximab
    Investigational medicinal product code
    MORAb-009
    Other name
    MORAb-009
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    During Combination Treatment Phase, subjects received amatuximab 5 mg/kg, infusion, intravenously, once weekly in 21-day cycles. Following completion of the Combination Treatment Phase, subjects who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression.

    Investigational medicinal product name
    Premetrexed
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    During Combination Treatment Phase, subjects received pemetrexed 500 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    During Combination Treatment Phase, subjects received cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.

    Arm title
    		 Placebo + Pemetrexed + Cisplatin
    Arm description
    		 During combination treatment phase, subjects received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, subjects who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression.
    Arm type
    		 Placebo and experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    During Combination Treatment Phase, subjects received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles. Following completion of the Combination Treatment Phase, subjects who had not progressed entered the Maintenance Phase and continued to receive placebo matched to amatuximab infusion, infusion, intravenously, once weekly until disease progression.

    Investigational medicinal product name
    Premetrexed
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    During Combination Treatment Phase, subjects received pemetrexed 500 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    During Combination Treatment Phase, subjects received cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.

    Number of subjects in period 1
    		Amatuximab + Pemetrexed + Cisplatin Placebo + Pemetrexed + Cisplatin
    Started
    52
    54
    Completed
    26
    29
    Not completed
    26
    25
         Consent withdrawn by subject
    4
    2
         Progressive Disease (Radiographic test)
    3
    3
         Adverse event, non-fatal
    12
    4
         Death
    1
    1
         Other
    1
    -
         Investigator Discretion
    1
    1
         Test Article Held for Greater than 21Day
    4
    1
         Sponsor Decision
    -
    12
         Progressive Disease(Clinical assessment)
    -
    1
    Period 2
    Period 2 title
    Maintenance Treatment Phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Amatuximab + Pemetrexed + Cisplatin
    Arm description
    		 During combination treatment phase, subjects received amatuximab 5 mg/kg, infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, subjects who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Amatuximab
    Investigational medicinal product code
    MORAb-009
    Other name
    MORAb-009
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    During Combination Treatment Phase, subjects received amatuximab 5 mg/kg, infusion, intravenously, once weekly in 21-day cycles. Following completion of the Combination Treatment Phase, subjects who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression.

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    During Combination Treatment Phase, subjects received pemetrexed 500 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    During Combination Treatment Phase, subjects received cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.

    Arm title
    		 Placebo + Pemetrexed + Cisplatin
    Arm description
    		 During combination treatment phase, subjects received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, subjects who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression.
    Arm type
    		 Placebo and experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    During Combination Treatment Phase, subjects received placebo matched to amatuximab infusion, infusion, intravenously, once weekly in 21-day cycles. Following completion of the Combination Treatment Phase, subjects who had not progressed entered the Maintenance Phase and continued to receive placebo matched to amatuximab infusion, infusion, intravenously, once weekly until disease progression.

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    During Combination Treatment Phase, subjects received pemetrexed 500 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    During Combination Treatment Phase, subjects received cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.

    Number of subjects in period 2
    		Amatuximab + Pemetrexed + Cisplatin Placebo + Pemetrexed + Cisplatin
    Started
    26
    29
    Treated
    25
    29
    Completed
    0
    0
    Not completed
    26
    29
         Progressive Disease (Radiographic test)
    15
    10
         Consent withdrawn by subject
    -
    1
         Adverse event, non-fatal
    -
    3
         Not Treated
    1
    -
         Test Article Held for Greater than 21Day
    10
    -
         Sponsor Decision
    -
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Amatuximab + Pemetrexed + Cisplatin
    Reporting group description
    		 During combination treatment phase, subjects received amatuximab 5 milligram per kilogram (mg/kg), infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 milligram per square meter (mg/m^2) and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, subjects who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression.

    Reporting group title
    Placebo + Pemetrexed + Cisplatin
    Reporting group description
    		 During combination treatment phase, subjects received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, subjects who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression.

    Reporting group values
    		 Amatuximab + Pemetrexed + Cisplatin Placebo + Pemetrexed + Cisplatin Total
    Number of subjects
    		 52 54 106
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 15 18 33
        From 65-84 years
    		 37 35 72
        85 years and over
    		 0 1 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 67.90 ± 6.08 66.90 ± 7.96 -
    Gender categorical
    Units: Subjects
        Female
    		 15 14 29
        Male
    		 37 40 77
    Ethnicity characteristics
    Units: Subjects
        Hispanic or Latino
    		 1 7 8
        Not Hispanic or Latino
    		 42 37 79
        Unknown or Not Reported
    		 9 10 19
    Race characteristics
    Units: Subjects
        Asian
    		 1 0 1
        Black or African American
    		 0 1 1
        White
    		 45 46 91
        Unknown or Not Reported
    		 6 7 13

    End points

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    End points reporting groups
    Reporting group title
    Amatuximab + Pemetrexed + Cisplatin
    Reporting group description
    		 During combination treatment phase, subjects received amatuximab 5 milligram per kilogram (mg/kg), infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 milligram per square meter (mg/m^2) and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, subjects who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression.

    Reporting group title
    Placebo + Pemetrexed + Cisplatin
    Reporting group description
    		 During combination treatment phase, subjects received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, subjects who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression.
    Reporting group title
    Amatuximab + Pemetrexed + Cisplatin
    Reporting group description
    		 During combination treatment phase, subjects received amatuximab 5 mg/kg, infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, subjects who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression.

    Reporting group title
    Placebo + Pemetrexed + Cisplatin
    Reporting group description
    		 During combination treatment phase, subjects received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, subjects who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression.

    Subject analysis set title
    Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    During combination treatment phase, subjects received amatuximab 5 mg/kg, infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.

    Subject analysis set title
    Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    During combination treatment phase, subjects received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.

    Subject analysis set title
    Maintenance Treatment Phase: Amatuximab
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Following completion of the Combination Treatment Phase, subjects who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression.

    Subject analysis set title
    Maintenance Treatment Phase: Placebo
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Following completion of the Combination Treatment Phase, subjects who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression.

    Primary: Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) [1]
    End point description
    AEs includes both non-SAEs and SAEs and the same subject can have both SAEs and as well non-SAEs. The safety analysis set was defined as all randomized subjects who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Baseline up to 3 years
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analyzed for this endpoint.
    End point values
    		 Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin Maintenance Treatment Phase: Amatuximab Maintenance Treatment Phase: Placebo
    Number of subjects analysed
    52
    54
    25
    29
    Units: subjects
        AEs
    50
    52
    19
    21
        SAEs
    15
    11
    1
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first dose of study drug up to 30 days after the last dose of study drug or until date of death (approximately up to 3 years)
    Adverse event reporting additional description
    Deaths that happened anytime during the study (including those during the treatment and after treatment discontinuation) are reported in this section.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin
    Reporting group description
    		 During combination treatment phase, subjects received amatuximab 5 mg/kg, infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.

    Reporting group title
    Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin
    Reporting group description
    		 During combination treatment phase, subjects received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles.

    Reporting group title
    Maintenance Treatment Phase: Amatuximab
    Reporting group description
    		 Following completion of the Combination Treatment Phase, subjects who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression.

    Reporting group title
    Maintenance Treatment Phase: Placebo
    Reporting group description
    		 Following completion of the Combination Treatment Phase, subjects who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression.

    Serious adverse events
    		 Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin Maintenance Treatment Phase: Amatuximab Maintenance Treatment Phase: Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 52 (28.85%)
    11 / 54 (20.37%)
    1 / 25 (4.00%)
    4 / 29 (13.79%)
         number of deaths (all causes)
    6
    3
    2
    1
         number of deaths resulting from adverse events
    1
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 54 (0.00%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 54 (0.00%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 54 (0.00%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 54 (0.00%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 54 (1.85%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 54 (1.85%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 54 (1.85%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 54 (0.00%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 52 (0.00%)
    2 / 54 (3.70%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 54 (0.00%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Organic brain syndrome
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 54 (0.00%)
    0 / 25 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    2 / 52 (3.85%)
    1 / 54 (1.85%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 54 (1.85%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 54 (1.85%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 54 (0.00%)
    0 / 25 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 52 (0.00%)
    2 / 54 (3.70%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 54 (0.00%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 54 (1.85%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Amaurosis
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 54 (0.00%)
    1 / 25 (4.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 54 (0.00%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 54 (0.00%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 52 (3.85%)
    1 / 54 (1.85%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 54 (0.00%)
    0 / 25 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    3 / 52 (5.77%)
    2 / 54 (3.70%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 52 (0.00%)
    2 / 54 (3.70%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 52 (1.92%)
    2 / 54 (3.70%)
    0 / 25 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 54 (1.85%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 54 (1.85%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 54 (0.00%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 52 (3.85%)
    0 / 54 (0.00%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 54 (1.85%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mucosal infection
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 54 (0.00%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 54 (0.00%)
    0 / 25 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 52 (3.85%)
    0 / 54 (0.00%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 54 (0.00%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Combination Treatment Phase:Amatuximab + Pemetrexed +Cisplatin Combination Treatment Phase: Placebo + Pemetrexed + Cisplatin Maintenance Treatment Phase: Amatuximab Maintenance Treatment Phase: Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    50 / 52 (96.15%)
    51 / 54 (94.44%)
    19 / 25 (76.00%)
    21 / 29 (72.41%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cancer pain
         subjects affected / exposed
    1 / 52 (1.92%)
    3 / 54 (5.56%)
    0 / 25 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    1
    4
    0
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 52 (5.77%)
    0 / 54 (0.00%)
    0 / 25 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    6
    0
    0
    1
    Hypotension
         subjects affected / exposed
    4 / 52 (7.69%)
    0 / 54 (0.00%)
    0 / 25 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    4
    0
    0
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    11 / 52 (21.15%)
    18 / 54 (33.33%)
    1 / 25 (4.00%)
    6 / 29 (20.69%)
         occurrences all number
    18
    48
    8
    9
    Chills
         subjects affected / exposed
    6 / 52 (11.54%)
    1 / 54 (1.85%)
    0 / 25 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    6
    2
    0
    1
    Fatigue
         subjects affected / exposed
    18 / 52 (34.62%)
    19 / 54 (35.19%)
    3 / 25 (12.00%)
    2 / 29 (6.90%)
         occurrences all number
    27
    31
    3
    3
    Non-cardiac chest pain
         subjects affected / exposed
    4 / 52 (7.69%)
    3 / 54 (5.56%)
    2 / 25 (8.00%)
    2 / 29 (6.90%)
         occurrences all number
    5
    3
    2
    3
    Oedema peripheral
         subjects affected / exposed
    3 / 52 (5.77%)
    3 / 54 (5.56%)
    0 / 25 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    3
    6
    0
    2
    Pyrexia
         subjects affected / exposed
    7 / 52 (13.46%)
    3 / 54 (5.56%)
    0 / 25 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    8
    5
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    8 / 52 (15.38%)
    6 / 54 (11.11%)
    4 / 25 (16.00%)
    5 / 29 (17.24%)
         occurrences all number
    12
    6
    7
    6
    Dyspnoea
         subjects affected / exposed
    9 / 52 (17.31%)
    3 / 54 (5.56%)
    4 / 25 (16.00%)
    0 / 29 (0.00%)
         occurrences all number
    10
    4
    7
    0
    Hiccups
         subjects affected / exposed
    1 / 52 (1.92%)
    3 / 54 (5.56%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Productive cough
         subjects affected / exposed
    4 / 52 (7.69%)
    3 / 54 (5.56%)
    2 / 25 (8.00%)
    2 / 29 (6.90%)
         occurrences all number
    4
    3
    2
    3
    Pulmonary embolism
         subjects affected / exposed
    3 / 52 (5.77%)
    1 / 54 (1.85%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    3
    1
    0
    0
    Epistaxis
         subjects affected / exposed
    4 / 52 (7.69%)
    2 / 54 (3.70%)
    1 / 25 (4.00%)
    0 / 29 (0.00%)
         occurrences all number
    5
    2
    1
    0
    Dyspnoea exertional
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 54 (0.00%)
    2 / 25 (8.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    4 / 52 (7.69%)
    1 / 54 (1.85%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    4
    1
    0
    0
    Insomnia
         subjects affected / exposed
    3 / 52 (5.77%)
    4 / 54 (7.41%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    3
    4
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 52 (0.00%)
    3 / 54 (5.56%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 52 (0.00%)
    3 / 54 (5.56%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Blood creatinine increased
         subjects affected / exposed
    3 / 52 (5.77%)
    6 / 54 (11.11%)
    0 / 25 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    5
    7
    0
    2
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    6 / 52 (11.54%)
    0 / 54 (0.00%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    9
    0
    0
    0
    Cardiac disorders
    Sinus tachycardia
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 54 (0.00%)
    0 / 25 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    0
    0
    2
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    5 / 52 (9.62%)
    6 / 54 (11.11%)
    0 / 25 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    5
    8
    0
    1
    Headache
         subjects affected / exposed
    6 / 52 (11.54%)
    4 / 54 (7.41%)
    1 / 25 (4.00%)
    1 / 29 (3.45%)
         occurrences all number
    6
    4
    1
    1
    Paraesthesia
         subjects affected / exposed
    7 / 52 (13.46%)
    2 / 54 (3.70%)
    3 / 25 (12.00%)
    1 / 29 (3.45%)
         occurrences all number
    9
    3
    4
    1
    Peripheral sensory neuropathy
         subjects affected / exposed
    2 / 52 (3.85%)
    5 / 54 (9.26%)
    0 / 25 (0.00%)
    4 / 29 (13.79%)
         occurrences all number
    2
    9
    0
    6
    Tremor
         subjects affected / exposed
    2 / 52 (3.85%)
    3 / 54 (5.56%)
    0 / 25 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    2
    3
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    11 / 52 (21.15%)
    12 / 54 (22.22%)
    3 / 25 (12.00%)
    2 / 29 (6.90%)
         occurrences all number
    29
    21
    11
    2
    Leukopenia
         subjects affected / exposed
    3 / 52 (5.77%)
    1 / 54 (1.85%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    3
    1
    0
    0
    Neutropenia
         subjects affected / exposed
    13 / 52 (25.00%)
    10 / 54 (18.52%)
    2 / 25 (8.00%)
    0 / 29 (0.00%)
         occurrences all number
    35
    28
    2
    0
    Thrombocytopenia
         subjects affected / exposed
    5 / 52 (9.62%)
    1 / 54 (1.85%)
    1 / 25 (4.00%)
    0 / 29 (0.00%)
         occurrences all number
    7
    1
    1
    0
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    5 / 52 (9.62%)
    3 / 54 (5.56%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    6
    4
    0
    0
    Eye disorders
    Dry eye
         subjects affected / exposed
    3 / 52 (5.77%)
    2 / 54 (3.70%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    3
    2
    0
    0
    Lacrimation increased
         subjects affected / exposed
    4 / 52 (7.69%)
    1 / 54 (1.85%)
    0 / 25 (0.00%)
    1 / 29 (3.45%)
         occurrences all number
    5
    1
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 52 (5.77%)
    2 / 54 (3.70%)
    2 / 25 (8.00%)
    0 / 29 (0.00%)
         occurrences all number
    3
    4
    2
    0
    Abdominal pain upper
         subjects affected / exposed
    2 / 52 (3.85%)
    5 / 54 (9.26%)
    1 / 25 (4.00%)
    1 / 29 (3.45%)
         occurrences all number
    5
    5
    2
    1
    Constipation
         subjects affected / exposed
    17 / 52 (32.69%)
    22 / 54 (40.74%)
    1 / 25 (4.00%)
    2 / 29 (6.90%)
         occurrences all number
    27
    32
    2
    2
    Diarrhoea
         subjects affected / exposed
    11 / 52 (21.15%)
    10 / 54 (18.52%)
    3 / 25 (12.00%)
    0 / 29 (0.00%)
         occurrences all number
    17
    13
    3
    0
    Dyspepsia
         subjects affected / exposed
    7 / 52 (13.46%)
    9 / 54 (16.67%)
    1 / 25 (4.00%)
    0 / 29 (0.00%)
         occurrences all number
    8
    10
    1
    0
    Nausea
         subjects affected / exposed
    34 / 52 (65.38%)
    39 / 54 (72.22%)
    1 / 25 (4.00%)
    3 / 29 (10.34%)
         occurrences all number
    78
    83
    1
    4
    Stomatitis
         subjects affected / exposed
    6 / 52 (11.54%)
    13 / 54 (24.07%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    7
    21
    0
    0
    Vomiting
         subjects affected / exposed
    13 / 52 (25.00%)
    18 / 54 (33.33%)
    2 / 25 (8.00%)
    3 / 29 (10.34%)
         occurrences all number
    25
    34
    2
    5
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 52 (1.92%)
    3 / 54 (5.56%)
    1 / 25 (4.00%)
    1 / 29 (3.45%)
         occurrences all number
    1
    3
    1
    1
    Dry skin
         subjects affected / exposed
    2 / 52 (3.85%)
    4 / 54 (7.41%)
    1 / 25 (4.00%)
    1 / 29 (3.45%)
         occurrences all number
    2
    4
    1
    1
    Hyperhidrosis
         subjects affected / exposed
    2 / 52 (3.85%)
    1 / 54 (1.85%)
    1 / 25 (4.00%)
    2 / 29 (6.90%)
         occurrences all number
    2
    1
    1
    2
    Pruritus
         subjects affected / exposed
    3 / 52 (5.77%)
    0 / 54 (0.00%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Rash
         subjects affected / exposed
    6 / 52 (11.54%)
    7 / 54 (12.96%)
    2 / 25 (8.00%)
    0 / 29 (0.00%)
         occurrences all number
    6
    10
    2
    0
    Night sweats
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 54 (1.85%)
    0 / 25 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    1
    0
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 52 (3.85%)
    5 / 54 (9.26%)
    1 / 25 (4.00%)
    0 / 29 (0.00%)
         occurrences all number
    4
    6
    1
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 52 (3.85%)
    2 / 54 (3.70%)
    2 / 25 (8.00%)
    1 / 29 (3.45%)
         occurrences all number
    2
    2
    2
    1
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    4 / 52 (7.69%)
    4 / 54 (7.41%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    6
    7
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    4 / 52 (7.69%)
    1 / 54 (1.85%)
    3 / 25 (12.00%)
    1 / 29 (3.45%)
         occurrences all number
    4
    1
    3
    1
    Tooth abscess
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 54 (0.00%)
    2 / 25 (8.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Influenza
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 54 (0.00%)
    2 / 25 (8.00%)
    0 / 29 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    14 / 52 (26.92%)
    17 / 54 (31.48%)
    1 / 25 (4.00%)
    2 / 29 (6.90%)
         occurrences all number
    23
    25
    1
    2
    Dehydration
         subjects affected / exposed
    3 / 52 (5.77%)
    2 / 54 (3.70%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    3
    2
    0
    0
    Hypokalaemia
         subjects affected / exposed
    3 / 52 (5.77%)
    3 / 54 (5.56%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    4
    3
    0
    0
    Hypomagnesaemia
         subjects affected / exposed
    2 / 52 (3.85%)
    3 / 54 (5.56%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    2
    3
    0
    0
    Hyponatraemia
         subjects affected / exposed
    1 / 52 (1.92%)
    3 / 54 (5.56%)
    0 / 25 (0.00%)
    0 / 29 (0.00%)
         occurrences all number
    1
    5
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Apr 2015
    Updated the inclusion and exclusion criteria, Quality of Life measurements was corrected from 6 subcategories to 5, and removed hemoptysis, added clarity on protocol conduct, ensured consistent terminology used throughout document, added clarity on administration of premedications, and other editorial changes.
    30 Jan 2017
    Removed all the efficacy endpoints.

    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 due to business decision. No safety concerns involved in decision to terminate this study.
    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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