Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A randomized phase II study evaluating efficacy and safety of 2nd or 3rd line treatment by Nivolumab monotherapy or Nivolumab plus Ipilimumab, for unresectable Malignant Pleural Mesothelioma (MPM) patients

    Summary
    EudraCT number
    		 2015-004475-75
    Trial protocol
    		 FR  
    Global end of trial date
    22 Jun 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Feb 2022
    First version publication date
    11 Feb 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    IFCT-1501
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02716272
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IFCT
    Sponsor organisation address
    10 rue de la Grange-Batelière, PARIS, France, 75009
    Public contact
    Contact, IFCT, 33 156811045, contact@ifct.fr
    Scientific contact
    Contact, IFCT, 0156811046 156811045, contact@ifct.fr
    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
    01 Aug 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jun 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    We raise the hypothesis that inhibition of immune PD-1+/- CTLA-4 check-point(s) would delay tumor progression in patients with unresectable MPM, experiencing disease progression after one or two lines of chemotherapy including at least first-line with pemetrexed and platinum, without altering significantly the quality of life of patients.
    Protection of trial subjects
    Algorithms for management of adverse events were provided in the protocol.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Mar 2016
    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: 125
    Worldwide total number of subjects
    125
    EEA total number of subjects
    125
    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)
    27
    From 65 to 84 years
    94
    85 years and over
    4

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 A total of 125 subjects (63 in the nivolumab arm and 62 in the nivolumab plus ipilimumab arm) were randomized in 21 centers, 124 subjects (63 in the nivolumab arm and 61 in the nivolumab plus ipilimumab arm) received at least one dose of the allocated treatment.

    Pre-assignment
    Screening details
    		 Eligible patients were aged 18 years or older with an Eastern Cooperative Oncology Group performance status of 0–1, histologically proven malignant pleural mesothelioma progressing after first-line or second-line pemetrexed and platinum based treatments, measurable disease by CT, and life expectancy greater than 12 weeks.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Monotherapy arm
    Arm description
    		 Nivolumab was administered IV over 60 minutes at 3 mg/kg every 2 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3 mg/kg every 2 weeks over 60 minutes

    Arm title
    		 Combination arm
    Arm description
    		 Nivolumab was administered IV over 60 minutes at 3 mg/kg every 2 weeks combined with ipilimumab administered IV over 90 minutes at 1 mg/kg every 6 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3 mg/kg every 2 weeks over 60 minutes

    Investigational medicinal product name
    Ipilimumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1 mg/kg every 6 weeks over 90 minutes

    Number of subjects in period 1
    		Monotherapy arm Combination arm
    Started
    63
    62
    Completed
    3
    1
    Not completed
    60
    61
         Adverse event, serious fatal
    1
    6
         Patient's choice
    1
    -
         Adverse event, non-fatal
    3
    14
         Intercurrent disease
    1
    1
         Other
    -
    1
         Second cancer
    1
    -
         Disease progression and toxicity
    2
    -
         Lack of efficacy
    51
    39

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Monotherapy arm
    Reporting group description
    		 Nivolumab was administered IV over 60 minutes at 3 mg/kg every 2 weeks

    Reporting group title
    Combination arm
    Reporting group description
    		 Nivolumab was administered IV over 60 minutes at 3 mg/kg every 2 weeks combined with ipilimumab administered IV over 90 minutes at 1 mg/kg every 6 weeks.

    Reporting group values
    		 Monotherapy arm Combination arm Total
    Number of subjects
    		 63 62 125
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 71.23 ( 9.46 ) 70.36 ( 8.99 ) -
    Gender categorical
    Units: Subjects
        Female
    		 16 9 25
        Male
    		 47 53 100
    Smoking status
    Units: Subjects
        Never smoker
    		 28 24 52
        Smoker
    		 35 38 73
    Histology
    Units: Subjects
        Biphasic/mixed
    		 11 5 16
        Sarcomatoid
    		 0 4 4
        Epithelioid
    		 52 53 105
    ECOG Performance status
    Units: Subjects
        PS = 0
    		 20 24 44
        PS = 1
    		 43 37 80
        PS = 2
    		 0 1 1
    Number of prior line
    Units: Subjects
        1 prior line
    		 44 42 86
        2 prior lines
    		 17 19 36
        3 prior lines
    		 1 1 2
        4 prior lines
    		 1 0 1
    Chemosensitivity to cisplatin/pemetrexed
    Units: Subjects
        Progression before 3 months
    		 21 18 39
        Progression after 3 months
    		 42 44 86
    PD-L1 class 1
    Units: Subjects
        < 1%
    		 31 27 58
        ≥1%
    		 19 22 41
        MISSING
    		 13 13 26
    PD-L1 class 2
    Units: Subjects
        <50%
    		 50 46 96
        ≥50%
    		 0 3 3
        MISSING
    		 13 13 26
    Tumour–node–metastasis classification
    Units: Subjects
        Stage I-II
    		 7 11 18
        Stage III-IV
    		 56 51 107
    Leucocytes
    Units: Subjects
        < 8.3 x10^9 per L
    		 43 41 84
        ≥ 8.3 x10^9 per L
    		 20 21 41
    Hemoglobin
    Units: Subjects
        ≤ 12 g/L
    		 30 25 55
        > 12 g/L
    		 33 37 70
    Platelets
    Units: Subjects
        < 350 x 10^9 per L
    		 46 43 89
        ≥ 350 x 10^9 per L
    		 17 19 36
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 72.92 ( 13.58 ) 73.68 ( 14.82 ) -
    Number of pack-years
    Units: Pack-years
        arithmetic mean (standard deviation)
    		 23.47 ( 15.64 ) 22.82 ( 22.11 ) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Monotherapy arm
    Reporting group description
    		 Nivolumab was administered IV over 60 minutes at 3 mg/kg every 2 weeks

    Reporting group title
    Combination arm
    Reporting group description
    		 Nivolumab was administered IV over 60 minutes at 3 mg/kg every 2 weeks combined with ipilimumab administered IV over 90 minutes at 1 mg/kg every 6 weeks.

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Patient who received at least one dose of the allocated treatment

    Subject analysis set title
    Efficacy population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Patients with no major deviation from the inclusion and exclusion criteria

    Subject analysis set title
    ITT population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intention-to-treat population

    Primary: Disease Control Rate at 12 weeks assessed by the Investigator

    		 Close Top of page
    End point title
    		 Disease Control Rate at 12 weeks assessed by the Investigator [1]
    End point description
    End point type
    Primary
    End point timeframe
    12 weeks after randomization
    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: Non comparative study
    End point values
    		 Monotherapy arm Combination arm Efficacy population
    Number of subjects analysed
    63
    62
    118
    Units: percent
        number (confidence interval 95%)
    50.0 (36.7 to 63.3)
    57.4 (44.2 to 70.6)
    53.7 (44.3 to 63.1)
    No statistical analyses for this end point

    Secondary: Disease Control Rate at 12 weeks assessed by the Blinded Independant Review Committee

    		 Close Top of page
    End point title
    		 Disease Control Rate at 12 weeks assessed by the Blinded Independant Review Committee
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks after randomization
    End point values
    		 Monotherapy arm Combination arm Efficacy population
    Number of subjects analysed
    54 [2]
    54 [3]
    108 [4]
    Units: percent
        number (confidence interval 95%)
    44.4 (31.2 to 57.7)
    50.0 (36.7 to 63.3)
    47.2 (37.8 to 56.6)
    Notes
    [2] - The first 108 eligible patients were analysed as planned in the protocol
    [3] - The first 108 eligible patients were analysed as planned in the protocol
    [4] - The first 108 eligible patients were analysed as planned in the protocol
    No statistical analyses for this end point

    Secondary: Overall Response Rate at 12 weeks assessed by the Blinded Independant Review Committee

    		 Close Top of page
    End point title
    		 Overall Response Rate at 12 weeks assessed by the Blinded Independant Review Committee
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks after randomization
    End point values
    		 Monotherapy arm Combination arm Efficacy population
    Number of subjects analysed
    54 [5]
    54 [6]
    108 [7]
    Units: percent
        number (confidence interval 95%)
    18.5 (8.2 to 28.9)
    27.8 (15.8 to 39.7)
    23.2 (15.2 to 31.1)
    Notes
    [5] - The first 108 eligible patients were analysed as planned in the protocol
    [6] - The first 108 eligible patients were analysed as planned in the protocol
    [7] - The first 108 eligible patients were analysed as planned in the protocol
    No statistical analyses for this end point

    Secondary: Overall Response Rate at 12 weeks assessed by the Investigator

    		 Close Top of page
    End point title
    		 Overall Response Rate at 12 weeks assessed by the Investigator
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks after randomization
    End point values
    		 Monotherapy arm Combination arm Efficacy population
    Number of subjects analysed
    54 [8]
    54 [9]
    108 [10]
    Units: Percent
        number (confidence interval 95%)
    13.0 (4.0 to 21.9)
    18.5 (8.2 to 28.9)
    15.7 (8.9 to 22.6)
    Notes
    [8] - The first 108 eligible patients were analysed as planned in the protocol
    [9] - The first 108 eligible patients were analysed as planned in the protocol
    [10] - The first 108 eligible patients were analysed as planned in the protocol
    No statistical analyses for this end point

    Secondary: Progression Free survival

    		 Close Top of page
    End point title
    		 Progression Free survival
    End point description
    End point type
    Secondary
    End point timeframe
    Time from date of inclusion to the earliest date of disease progression. The median follow-up was 18.40 months in both arms.
    End point values
    		 Monotherapy arm Combination arm
    Number of subjects analysed
    63
    62
    Units: Months
        median (confidence interval 95%)
    3.97 (2.79 to 5.68)
    5.44 (3.06 to 8.21)
    No statistical analyses for this end point

    Secondary: Overall survival

    		 Close Top of page
    End point title
    		 Overall survival
    End point description
    End point type
    Secondary
    End point timeframe
    Time from date of inclusion to the date of death due to any cause. The median follow-up was 37.48 months in both arms.
    End point values
    		 Monotherapy arm Combination arm
    Number of subjects analysed
    63
    62
    Units: Months
        median (confidence interval 95%)
    11.86 (6.73 to 17.44)
    15.93 (10.68 to 22.21)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    The timeframe events extends from the date of signature of the informed consent until 100 days after the last day of study treatment except for adverse events related to study drug.
    Adverse event reporting additional description
    The maximal grade of adverse events was collected by cycle of treatment.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    Safety Population
    Reporting group description
    		 -

    Reporting group title
    Arm A Safety population
    Reporting group description
    		 -

    Reporting group title
    Arm B safety population
    Reporting group description
    		 -

    Serious adverse events
    		 Safety Population Arm A Safety population Arm B safety population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    61 / 124 (49.19%)
    25 / 63 (39.68%)
    36 / 61 (59.02%)
         number of deaths (all causes)
    107
    55
    52
         number of deaths resulting from adverse events
    24
    13
    10
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant pleural effusion
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 63 (1.59%)
    0 / 61 (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
    Metastases to peritoneum
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Neoplasm progression
         subjects affected / exposed
    8 / 124 (6.45%)
    4 / 63 (6.35%)
    4 / 61 (6.56%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 8
    0 / 4
    0 / 4
    Vascular disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 63 (1.59%)
    0 / 61 (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
    Phlebitis
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 63 (1.59%)
    0 / 61 (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
    Chest pain
         subjects affected / exposed
    2 / 124 (1.61%)
    1 / 63 (1.59%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 63 (1.59%)
    0 / 61 (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
    General physical health deterioration
         subjects affected / exposed
    17 / 124 (13.71%)
    11 / 63 (17.46%)
    6 / 61 (9.84%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 11
    0 / 6
         deaths causally related to treatment / all
    0 / 10
    0 / 6
    0 / 4
    Hyperthermia malignant
         subjects affected / exposed
    2 / 124 (1.61%)
    1 / 63 (1.59%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    2 / 124 (1.61%)
    1 / 63 (1.59%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Cough
         subjects affected / exposed
    2 / 124 (1.61%)
    1 / 63 (1.59%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    9 / 124 (7.26%)
    5 / 63 (7.94%)
    4 / 61 (6.56%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Lung disorder
         subjects affected / exposed
    2 / 124 (1.61%)
    0 / 63 (0.00%)
    2 / 61 (3.28%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    4 / 124 (3.23%)
    2 / 63 (3.17%)
    2 / 61 (3.28%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 63 (1.59%)
    0 / 61 (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
    Respiratory distress
         subjects affected / exposed
    3 / 124 (2.42%)
    1 / 63 (1.59%)
    2 / 61 (3.28%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 63 (1.59%)
    0 / 61 (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
    Psychiatric disorders
    Completed suicide
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Injury, poisoning and procedural complications
    Infusion related reaction
         subjects affected / exposed
    4 / 124 (3.23%)
    1 / 63 (1.59%)
    3 / 61 (4.92%)
         occurrences causally related to treatment / all
    4 / 4
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis chemical
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 63 (1.59%)
    0 / 61 (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
    Atrial fibrillation
         subjects affected / exposed
    4 / 124 (3.23%)
    1 / 63 (1.59%)
    3 / 61 (4.92%)
         occurrences causally related to treatment / all
    3 / 4
    1 / 1
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    3 / 124 (2.42%)
    1 / 63 (1.59%)
    2 / 61 (3.28%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 63 (1.59%)
    0 / 61 (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
    Pericardial effusion
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    2 / 124 (1.61%)
    1 / 63 (1.59%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 63 (1.59%)
    0 / 61 (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
    Encephalitis
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    Acute polyneuropathy
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Retinal artery occlusion
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 63 (1.59%)
    0 / 61 (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
    Gastrointestinal disorders
    Autoimmune colitis
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    2 / 124 (1.61%)
    1 / 63 (1.59%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 124 (1.61%)
    0 / 63 (0.00%)
    2 / 61 (3.28%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    2 / 124 (1.61%)
    1 / 63 (1.59%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Gastritis
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal obstruction
         subjects affected / exposed
    2 / 124 (1.61%)
    0 / 63 (0.00%)
    2 / 61 (3.28%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 63 (1.59%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    Hepatobiliary disorders
    Hepatitis fulminant
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    Budd-Chiari syndrome
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatocellular injury
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatitis toxic
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis bullous
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pemphigoid
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 124 (1.61%)
    0 / 63 (0.00%)
    2 / 61 (3.28%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    Pleurisy
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 63 (1.59%)
    0 / 61 (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
    Endocrine disorders
    Hypophysitis
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bone pain
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 63 (1.59%)
    0 / 61 (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
    Pain in extremity
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 63 (1.59%)
    0 / 61 (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
    Polyarthritis
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 63 (1.59%)
    0 / 61 (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
    Catheter site infection
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 63 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 63 (1.59%)
    0 / 61 (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
    Mediastinal abscess
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 63 (1.59%)
    0 / 61 (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
    Pneumonia
         subjects affected / exposed
    3 / 124 (2.42%)
    2 / 63 (3.17%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 63 (1.59%)
    0 / 61 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Safety Population Arm A Safety population Arm B safety population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    124 / 124 (100.00%)
    63 / 63 (100.00%)
    61 / 61 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    8 / 124 (6.45%)
    3 / 63 (4.76%)
    5 / 61 (8.20%)
         occurrences all number
    13
    6
    7
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    94 / 124 (75.81%)
    48 / 63 (76.19%)
    46 / 61 (75.41%)
         occurrences all number
    406
    210
    196
    Chest pain
         subjects affected / exposed
    70 / 124 (56.45%)
    34 / 63 (53.97%)
    36 / 61 (59.02%)
         occurrences all number
    198
    90
    108
    Pyrexia
         subjects affected / exposed
    31 / 124 (25.00%)
    10 / 63 (15.87%)
    21 / 61 (34.43%)
         occurrences all number
    45
    14
    31
    Oedema peripheral
         subjects affected / exposed
    23 / 124 (18.55%)
    13 / 63 (20.63%)
    10 / 61 (16.39%)
         occurrences all number
    42
    21
    21
    General physical health deterioration
         subjects affected / exposed
    28 / 124 (22.58%)
    15 / 63 (23.81%)
    13 / 61 (21.31%)
         occurrences all number
    37
    17
    20
    Mucosal inflammation
         subjects affected / exposed
    12 / 124 (9.68%)
    6 / 63 (9.52%)
    6 / 61 (9.84%)
         occurrences all number
    25
    19
    6
    Chills
         subjects affected / exposed
    9 / 124 (7.26%)
    3 / 63 (4.76%)
    6 / 61 (9.84%)
         occurrences all number
    16
    9
    7
    Pain
         subjects affected / exposed
    6 / 124 (4.84%)
    1 / 63 (1.59%)
    5 / 61 (8.20%)
         occurrences all number
    6
    1
    5
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    90 / 124 (72.58%)
    48 / 63 (76.19%)
    42 / 61 (68.85%)
         occurrences all number
    306
    155
    151
    Cough
         subjects affected / exposed
    63 / 124 (50.81%)
    33 / 63 (52.38%)
    30 / 61 (49.18%)
         occurrences all number
    165
    79
    86
    Productive cough
         subjects affected / exposed
    14 / 124 (11.29%)
    8 / 63 (12.70%)
    6 / 61 (9.84%)
         occurrences all number
    30
    15
    15
    Pleural effusion
         subjects affected / exposed
    7 / 124 (5.65%)
    4 / 63 (6.35%)
    3 / 61 (4.92%)
         occurrences all number
    23
    6
    17
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    7 / 124 (5.65%)
    4 / 63 (6.35%)
    3 / 61 (4.92%)
         occurrences all number
    10
    6
    4
    Insomnia
         subjects affected / exposed
    6 / 124 (4.84%)
    5 / 63 (7.94%)
    2 / 61 (3.28%)
         occurrences all number
    8
    6
    2
    Investigations
    Weight decreased
         subjects affected / exposed
    23 / 124 (18.55%)
    15 / 63 (23.81%)
    18 / 61 (29.51%)
         occurrences all number
    67
    22
    45
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    13 / 124 (10.48%)
    8 / 63 (12.70%)
    5 / 61 (8.20%)
         occurrences all number
    62
    11
    51
    Blood creatinine increased
         subjects affected / exposed
    13 / 124 (10.48%)
    6 / 63 (9.52%)
    7 / 61 (11.48%)
         occurrences all number
    51
    29
    22
    Alanine aminotransferase increased
         subjects affected / exposed
    13 / 124 (10.48%)
    3 / 63 (4.76%)
    10 / 61 (16.39%)
         occurrences all number
    31
    3
    28
    Aspartate aminotransferase increased
         subjects affected / exposed
    14 / 124 (11.29%)
    5 / 63 (7.94%)
    9 / 61 (14.75%)
         occurrences all number
    29
    9
    20
    Lipase increased
         subjects affected / exposed
    8 / 124 (6.45%)
    4 / 63 (6.35%)
    4 / 61 (6.56%)
         occurrences all number
    16
    9
    7
    Blood alkaline phosphatase increased
         subjects affected / exposed
    7 / 124 (5.65%)
    1 / 63 (1.59%)
    6 / 61 (9.84%)
         occurrences all number
    16
    3
    13
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    6 / 124 (4.84%)
    4 / 63 (6.35%)
    2 / 61 (3.28%)
         occurrences all number
    10
    8
    2
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    5 / 124 (4.03%)
    1 / 63 (1.59%)
    4 / 61 (6.56%)
         occurrences all number
    6
    1
    5
    Tachycardia
         subjects affected / exposed
    4 / 124 (3.23%)
    0 / 63 (0.00%)
    4 / 61 (6.56%)
         occurrences all number
    5
    0
    5
    Nervous system disorders
    Neuralgia
         subjects affected / exposed
    7 / 124 (5.65%)
    3 / 63 (4.76%)
    4 / 61 (6.56%)
         occurrences all number
    24
    7
    17
    Headache
         subjects affected / exposed
    9 / 124 (7.26%)
    3 / 63 (4.76%)
    6 / 61 (9.84%)
         occurrences all number
    22
    3
    19
    Paraesthesia
         subjects affected / exposed
    6 / 124 (4.84%)
    2 / 63 (3.17%)
    4 / 61 (6.56%)
         occurrences all number
    12
    4
    8
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    60 / 124 (48.39%)
    27 / 63 (42.86%)
    33 / 61 (54.10%)
         occurrences all number
    296
    164
    132
    Thrombocytopenia
         subjects affected / exposed
    6 / 124 (4.84%)
    4 / 63 (6.35%)
    2 / 61 (3.28%)
         occurrences all number
    37
    18
    19
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    10 / 124 (8.06%)
    5 / 63 (7.94%)
    5 / 61 (8.20%)
         occurrences all number
    13
    6
    7
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    31 / 124 (25.00%)
    11 / 63 (17.46%)
    20 / 61 (32.79%)
         occurrences all number
    71
    20
    51
    Constipation
         subjects affected / exposed
    36 / 124 (29.03%)
    20 / 63 (31.75%)
    16 / 61 (26.23%)
         occurrences all number
    61
    33
    28
    Nausea
         subjects affected / exposed
    29 / 124 (23.39%)
    15 / 63 (23.81%)
    14 / 61 (22.95%)
         occurrences all number
    52
    32
    20
    Dry mouth
         subjects affected / exposed
    11 / 124 (8.87%)
    4 / 63 (6.35%)
    7 / 61 (11.48%)
         occurrences all number
    29
    16
    13
    Abdominal pain
         subjects affected / exposed
    16 / 124 (12.90%)
    8 / 63 (12.70%)
    8 / 61 (13.11%)
         occurrences all number
    27
    13
    14
    Dysphagia
         subjects affected / exposed
    13 / 124 (10.48%)
    7 / 63 (11.11%)
    6 / 61 (9.84%)
         occurrences all number
    25
    15
    10
    Abdominal pain upper
         subjects affected / exposed
    14 / 124 (11.29%)
    6 / 63 (9.52%)
    8 / 61 (13.11%)
         occurrences all number
    23
    9
    14
    Vomiting
         subjects affected / exposed
    12 / 124 (9.68%)
    5 / 63 (7.94%)
    7 / 61 (11.48%)
         occurrences all number
    17
    6
    11
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    21 / 124 (16.94%)
    6 / 63 (9.52%)
    15 / 61 (24.59%)
         occurrences all number
    107
    20
    87
    Rash
         subjects affected / exposed
    15 / 124 (12.10%)
    6 / 63 (9.52%)
    9 / 61 (14.75%)
         occurrences all number
    76
    34
    42
    Dry skin
         subjects affected / exposed
    12 / 124 (9.68%)
    3 / 63 (4.76%)
    9 / 61 (14.75%)
         occurrences all number
    36
    12
    24
    Hyperhidrosis
         subjects affected / exposed
    8 / 124 (6.45%)
    5 / 63 (7.94%)
    3 / 61 (4.92%)
         occurrences all number
    10
    6
    4
    Erythema
         subjects affected / exposed
    6 / 124 (4.84%)
    1 / 63 (1.59%)
    5 / 61 (8.20%)
         occurrences all number
    6
    1
    5
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    11 / 124 (8.87%)
    6 / 63 (9.52%)
    5 / 61 (8.20%)
         occurrences all number
    31
    21
    10
    Acute kidney injury
         subjects affected / exposed
    5 / 124 (4.03%)
    0 / 63 (0.00%)
    5 / 61 (8.20%)
         occurrences all number
    6
    0
    6
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    8 / 124 (6.45%)
    2 / 63 (3.17%)
    6 / 61 (9.84%)
         occurrences all number
    37
    13
    24
    Hypothyroidism
         subjects affected / exposed
    9 / 124 (7.26%)
    4 / 63 (6.35%)
    5 / 61 (8.20%)
         occurrences all number
    25
    6
    19
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    28 / 124 (22.58%)
    15 / 63 (23.81%)
    13 / 61 (21.31%)
         occurrences all number
    58
    23
    35
    Arthralgia
         subjects affected / exposed
    20 / 124 (16.13%)
    9 / 63 (14.29%)
    11 / 61 (18.03%)
         occurrences all number
    54
    21
    33
    Musculoskeletal chest pain
         subjects affected / exposed
    24 / 124 (19.35%)
    12 / 63 (19.05%)
    12 / 61 (19.67%)
         occurrences all number
    48
    15
    33
    Musculoskeletal pain
         subjects affected / exposed
    14 / 124 (11.29%)
    5 / 63 (7.94%)
    9 / 61 (14.75%)
         occurrences all number
    41
    13
    28
    Pain in extremity
         subjects affected / exposed
    12 / 124 (9.68%)
    7 / 63 (11.11%)
    5 / 61 (8.20%)
         occurrences all number
    15
    8
    7
    Muscle spasms
         subjects affected / exposed
    8 / 124 (6.45%)
    5 / 63 (7.94%)
    3 / 61 (4.92%)
         occurrences all number
    13
    9
    4
    Myalgia
         subjects affected / exposed
    9 / 124 (7.26%)
    4 / 63 (6.35%)
    5 / 61 (8.20%)
         occurrences all number
    11
    5
    6
    Neck pain
         subjects affected / exposed
    5 / 124 (4.03%)
    1 / 63 (1.59%)
    4 / 61 (6.56%)
         occurrences all number
    5
    1
    4
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    12 / 124 (9.68%)
    7 / 63 (11.11%)
    5 / 61 (8.20%)
         occurrences all number
    15
    7
    8
    Bronchitis
         subjects affected / exposed
    12 / 124 (9.68%)
    5 / 63 (7.94%)
    7 / 61 (11.48%)
         occurrences all number
    14
    6
    8
    Oral candidiasis
         subjects affected / exposed
    11 / 124 (8.87%)
    5 / 63 (7.94%)
    6 / 61 (9.84%)
         occurrences all number
    13
    6
    7
    Influenza
         subjects affected / exposed
    5 / 124 (4.03%)
    1 / 63 (1.59%)
    4 / 61 (6.56%)
         occurrences all number
    7
    1
    6
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    42 / 124 (33.87%)
    23 / 63 (36.51%)
    19 / 61 (31.15%)
         occurrences all number
    95
    47
    48
    Hypoalbuminaemia
         subjects affected / exposed
    5 / 124 (4.03%)
    5 / 63 (7.94%)
    0 / 61 (0.00%)
         occurrences all number
    15
    15
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Apr 2016
    Clarification f inclusion criteria, adding stratification criteria and amendment of the patient information letter.

    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 phase 2 nature of this trial was a conservative choice aimed solely to detect early efficacy (and tolerance) signals of two different immunotherapy regimens at the same time, with no preconceptions, and to select at least one of these regimen.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30660609
    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.

    European Medicines Agency © 1995-Fri Apr 26 08:29:20 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA