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    Clinical Trial Results:
    Phase 2 Placebo-controlled Double-blind Trial of Dasatinib Added to Gemcitabine for Subjects with Locally-advanced Pancreatic Cancer

    Summary
    EudraCT number
    2010-024595-26
    Trial protocol
    BE   HU   GB   AT   DE   CZ   IE   IT  
    Global end of trial date
    21 Apr 2015

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

    Trial information

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    Trial identification
    Sponsor protocol code
    287-11-201
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01395017
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Otsuka Pharmaceutical Development & Commercialization, Inc.
    Sponsor organisation address
    2440 Research Boulevard, Rockville, Maryland, United States, 20850
    Public contact
    Agnes Elekes, Otsuka Pharmaceutical Development & Commercialization, Inc. , +1 609-720-8453, agnes.elekes@otsuka-us.com
    Scientific contact
    Edwin Rock, Otsuka Pharmaceutical Development & Commercialization, Inc. , +1 609-524-6778, edwin.rock@otsuka-us.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Jun 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Nov 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Apr 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to compare overall survival (OS) of participants with locally advanced pancreatic cancer (LAPC) who were randomized to receive dasatinib added to standard of care (gemcitabine [GEM]) versus standard of care (GEM) plus placebo.
    Protection of trial subjects
    This trial was conducted in compliance with the protocol, International Conference on Harmonisation (ICH) Good Clinical Practice (GCP), and applicable local laws and regulatory requirements of the countries in which the trial was conducted, copies of the protocol, amendments, and informed consent form (ICF) were reviewed and approved by the governing institutional review board (IRB) or independent ethics committee (IEC) for each investigational site or country, as appropriate, prior to trial start or prior to implementation of the amendment at that site or country.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    03 Aug 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 28
    Country: Number of subjects enrolled
    United States: 37
    Country: Number of subjects enrolled
    Australia: 16
    Country: Number of subjects enrolled
    Austria: 3
    Country: Number of subjects enrolled
    Belgium: 7
    Country: Number of subjects enrolled
    Canada: 9
    Country: Number of subjects enrolled
    Czech Republic: 10
    Country: Number of subjects enrolled
    France: 26
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Hungary: 15
    Country: Number of subjects enrolled
    Ireland: 6
    Country: Number of subjects enrolled
    Italy: 8
    Country: Number of subjects enrolled
    Poland: 3
    Country: Number of subjects enrolled
    Romania: 7
    Country: Number of subjects enrolled
    Russian Federation: 24
    Worldwide total number of subjects
    202
    EEA total number of subjects
    116
    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)
    95
    From 65 to 84 years
    104
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    202 participants were enrolled at 79 study sites in 15 countries.

    Pre-assignment
    Screening details
    Participants were randomly assigned in a 1:1 ratio to receive dasatinib + GEM or placebo + GEM. Participants were stratified at the time of randomization by Baseline Eastern Cooperative Oncology Group Performance Status (ECOG PS) (0 versus 1) and intent to receive radiotherapy (RT) (yes or no).

    Period 1
    Period 1 title
    Overall Period (overall trial)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator
    Blinding implementation details
    To monitor participant safety, an independent data monitoring committee (IDMC) reviewed unblinded data. In addition, the IDMC reviewed unblinded data on the PFS endpoint after 151 Progression Free Survival events (disease progression, trial treatment discontinuation, or death) occurred. No study personnel directly involved with the study had access to unblinded data. The blind was not broken for any participant prior to database lock and overall study unblinding.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Dasatinib + GEM
    Arm description
    GEM 1000 mg/m2 by intravenous (IV) infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth once daily (QD).
    Arm type
    Active comparator

    Investigational medicinal product name
    Dasatinib
    Investigational medicinal product code
    SUB23159
    Other name
    Sprycel, Dasatinib monohydrate, BMS-35482
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    GEM 1000 mg/m2 by intravenous (IV) infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth once daily (QD).

    Arm title
    Placebo + GEM
    Arm description
    GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.

    Number of subjects in period 1
    Dasatinib + GEM Placebo + GEM
    Started
    100
    102
    Treated
    98
    101
    Completed
    0
    0
    Not completed
    100
    102
         Protocol deviation
    1
    2
         Death
    4
    3
         Physician decision
    11
    15
         Adverse event
    26
    12
         Consent withdrawn by subject
    14
    8
         Disease progression
    42
    58
         Sponsor discontinued study
    1
    4
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dasatinib + GEM
    Reporting group description
    GEM 1000 mg/m2 by intravenous (IV) infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth once daily (QD).

    Reporting group title
    Placebo + GEM
    Reporting group description
    GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.

    Reporting group values
    Dasatinib + GEM Placebo + GEM Total
    Number of subjects
    100 102 202
    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)
    47 48 95
        From 65-84 years
    51 53 104
        85 years and over
    2 1 3
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    64.8 ± 9.1 64.7 ± 9.6 -
    Gender categorical
    Units: Subjects
        Female
    43 56 99
        Male
    57 46 103

    End points

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    End points reporting groups
    Reporting group title
    Dasatinib + GEM
    Reporting group description
    GEM 1000 mg/m2 by intravenous (IV) infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth once daily (QD).

    Reporting group title
    Placebo + GEM
    Reporting group description
    GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.

    Primary: Overall Survival

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    End point title
    Overall Survival
    End point description
    Overall survival (OS) is the time from randomization until time of death from any cause by 02 December 2013. The intent-to-treat (ITT) data was used, which was composed of all randomized participants.
    End point type
    Primary
    End point timeframe
    From randomization until date of death from any cause by 02 December 2013
    End point values
    Dasatinib + GEM Placebo + GEM
    Number of subjects analysed
    100
    102
    Units: Days
        median (confidence interval 95%)
    375 (310 to 462)
    393 (356 to 467)
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Using a 1-sided alpha=0.2, a population of 200 participants (100 GEM plus dasatinib and 100 GEM plus placebo) has 79% power to show an increase in median OS from 10 to 13.3 months (hazard ratio [HR] =0.75, assuming analysis of 135 deaths).
    Comparison groups
    Dasatinib + GEM v Placebo + GEM
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    = 0.3864 [2]
    Method
    Cox proportional hazard model
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.19
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.85
         upper limit
    1.65
    Notes
    [1] - Adjusting for baseline factors - treatment, ECOG PS, region, CA19-9 level (< 1000 IU/mL or >/=1000 IU/mL), and RT during trial (yes or no).
    [2] - The log-rank test was used to test OS. As a sensitivity analysis, HR and its confidence interval was also provided for OS using the Cox proportional hazard model.

    Secondary: Progression Free Survival (PFS)

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    End point title
    Progression Free Survival (PFS)
    End point description
    PFS - time from randomization to unequivocal local or distant disease progression, death or discontinuation from trial for any reason by 02 December 2013. Progression events were determined according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 every 8 weeks. The ITT data was used, which was composed of all randomized participants.
    End point type
    Secondary
    End point timeframe
    Time from randomization to earliest PFS event by 02 December 2013
    End point values
    Dasatinib + GEM Placebo + GEM
    Number of subjects analysed
    100
    102
    Units: Days
        median (confidence interval 95%)
    167 (114 to 212)
    166 (158 to 199)
    Statistical analysis title
    Statistical analysis 1
    Statistical analysis description
    Trial has 88% power to show a median PFS increase from 5 to 7 months (with 1-sided alpha=0.15, total 176 events, HR=0.714).
    Comparison groups
    Dasatinib + GEM v Placebo + GEM
    Number of subjects included in analysis
    202
    Analysis specification
    Pre-specified
    Analysis type
    superiority [3]
    P-value
    = 0.6761 [4]
    Method
    Cox proportional hazard model
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.99
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.73
         upper limit
    1.34
    Notes
    [3] - Adjusting for baseline factors: treatment, ECOG PS, region, CA19-9 level (< 1000 IU/mL or >/=1000 IU/mL), and RT during trial (yes or no).
    [4] - The log-rank test was used to test PFS. As a sensitivity analysis, HR and its confidence interval was also provided for PFS using the Cox proportional hazard model.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs) were collected from randomization throughout each treatment cycle to final study visit. Follow-up visits conducted until all ongoing AEs resolved or clinically stable.
    Adverse event reporting additional description
    The safety data set (participants who received at least one dose of study treatment) included 98 participants in the Dasatinib + GEM group and 101 participants in the placebo + GEM group.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Dasatinib + GEM
    Reporting group description
    GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth QD.

    Reporting group title
    Placebo + GEM
    Reporting group description
    GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.

    Serious adverse events
    Dasatinib + GEM Placebo + GEM
    Total subjects affected by serious adverse events
         subjects affected / exposed
    53 / 98 (54.08%)
    48 / 101 (47.52%)
         number of deaths (all causes)
    9
    10
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant neoplasm progression
         subjects affected / exposed
    2 / 98 (2.04%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Metastases to bone
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Tumour haemorrhage
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device occlusion
         subjects affected / exposed
    5 / 98 (5.10%)
    5 / 101 (4.95%)
         occurrences causally related to treatment / all
    5 / 5
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised oedema
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthermia
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multi-organ failure
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Oedema
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    3 / 98 (3.06%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 98 (1.02%)
    4 / 101 (3.96%)
         occurrences causally related to treatment / all
    1 / 1
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stent malfunction
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chemical peritonitis
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal stoma complication
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural bile leak
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver function test abnormal
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Cardiac failure
         subjects affected / exposed
    4 / 98 (4.08%)
    2 / 101 (1.98%)
         occurrences causally related to treatment / all
    4 / 4
    2 / 2
         deaths causally related to treatment / all
    1 / 2
    0 / 1
    Cardiac failure acute
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiomyopathy
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sick sinus syndrome
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Pyloric stenosis
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthmatic crisis
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    2 / 98 (2.04%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    4 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea exertional
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    6 / 98 (6.12%)
    2 / 101 (1.98%)
         occurrences causally related to treatment / all
    6 / 6
    3 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary arterial hypertension
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary fibrosis
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 98 (3.06%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    4 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 98 (3.06%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    2 / 98 (2.04%)
    2 / 101 (1.98%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Constipation
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    3 / 98 (3.06%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal stenosis
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer perforation
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenitis
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nausea
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstruction gastric
         subjects affected / exposed
    3 / 98 (3.06%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic necrosis
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestine obstruction
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    3 / 98 (3.06%)
    2 / 101 (1.98%)
         occurrences causally related to treatment / all
    4 / 4
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal failure acute
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct obstruction
         subjects affected / exposed
    4 / 98 (4.08%)
    2 / 101 (1.98%)
         occurrences causally related to treatment / all
    4 / 4
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stenosis
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    4 / 98 (4.08%)
    2 / 101 (1.98%)
         occurrences causally related to treatment / all
    4 / 4
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    1 / 98 (1.02%)
    2 / 101 (1.98%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatotoxicity
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperbilirubinaemia
         subjects affected / exposed
    5 / 98 (5.10%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    5 / 5
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Necrolytic migratory erythema
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic skin eruption
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteonecrosis
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    2 / 98 (2.04%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Fluid retention
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    0 / 98 (0.00%)
    2 / 101 (1.98%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary sepsis
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary tract infection
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    2 / 98 (2.04%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia infection
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver abcess
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 98 (0.00%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia
         subjects affected / exposed
    3 / 98 (3.06%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Sepsis
         subjects affected / exposed
    2 / 98 (2.04%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal infection
         subjects affected / exposed
    1 / 98 (1.02%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    3 / 98 (3.06%)
    0 / 101 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 98 (1.02%)
    1 / 101 (0.99%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Dasatinib + GEM Placebo + GEM
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    93 / 98 (94.90%)
    98 / 101 (97.03%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    4 / 98 (4.08%)
    10 / 101 (9.90%)
         occurrences all number
    5
    10
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    17 / 98 (17.35%)
    16 / 101 (15.84%)
         occurrences all number
    35
    26
    Chest pain
         subjects affected / exposed
    2 / 98 (2.04%)
    7 / 101 (6.93%)
         occurrences all number
    2
    7
    Chills
         subjects affected / exposed
    6 / 98 (6.12%)
    4 / 101 (3.96%)
         occurrences all number
    6
    7
    Face oedema
         subjects affected / exposed
    5 / 98 (5.10%)
    1 / 101 (0.99%)
         occurrences all number
    5
    1
    Fatigue
         subjects affected / exposed
    50 / 98 (51.02%)
    46 / 101 (45.54%)
         occurrences all number
    179
    102
    Oedema peripheral
         subjects affected / exposed
    32 / 98 (32.65%)
    22 / 101 (21.78%)
         occurrences all number
    67
    30
    Pain
         subjects affected / exposed
    2 / 98 (2.04%)
    8 / 101 (7.92%)
         occurrences all number
    2
    9
    Pyrexia
         subjects affected / exposed
    22 / 98 (22.45%)
    27 / 101 (26.73%)
         occurrences all number
    49
    56
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    10 / 98 (10.20%)
    4 / 101 (3.96%)
         occurrences all number
    10
    4
    Depression
         subjects affected / exposed
    6 / 98 (6.12%)
    5 / 101 (4.95%)
         occurrences all number
    6
    5
    Insomnia
         subjects affected / exposed
    12 / 98 (12.24%)
    14 / 101 (13.86%)
         occurrences all number
    13
    14
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    22 / 98 (22.45%)
    14 / 101 (13.86%)
         occurrences all number
    60
    20
    Blood alkaline phosphatase increased
         subjects affected / exposed
    15 / 98 (15.31%)
    8 / 101 (7.92%)
         occurrences all number
    36
    18
    Blood bilirubin increased
         subjects affected / exposed
    13 / 98 (13.27%)
    6 / 101 (5.94%)
         occurrences all number
    19
    12
    Gamma glutamyltransferase increased
         subjects affected / exposed
    5 / 98 (5.10%)
    1 / 101 (0.99%)
         occurrences all number
    12
    1
    Haemaglobin decreased
         subjects affected / exposed
    5 / 98 (5.10%)
    6 / 101 (5.94%)
         occurrences all number
    11
    23
    Neutrophil count decreased
         subjects affected / exposed
    6 / 98 (6.12%)
    5 / 101 (4.95%)
         occurrences all number
    16
    12
    Platelet count decreased
         subjects affected / exposed
    7 / 98 (7.14%)
    4 / 101 (3.96%)
         occurrences all number
    14
    4
    Weight decreased
         subjects affected / exposed
    21 / 98 (21.43%)
    11 / 101 (10.89%)
         occurrences all number
    29
    14
    White blood cell count decreased
         subjects affected / exposed
    8 / 98 (8.16%)
    2 / 101 (1.98%)
         occurrences all number
    43
    8
    Aspartate aminotransferase increased
         subjects affected / exposed
    16 / 98 (16.33%)
    11 / 101 (10.89%)
         occurrences all number
    35
    19
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    50 / 98 (51.02%)
    28 / 101 (27.72%)
         occurrences all number
    139
    74
    Leukopenia
         subjects affected / exposed
    8 / 98 (8.16%)
    13 / 101 (12.87%)
         occurrences all number
    31
    29
    Lymphopenia
         subjects affected / exposed
    5 / 98 (5.10%)
    7 / 101 (6.93%)
         occurrences all number
    26
    36
    Neutropenia
         subjects affected / exposed
    53 / 98 (54.08%)
    49 / 101 (48.51%)
         occurrences all number
    176
    194
    Thrombocytopenia
         subjects affected / exposed
    38 / 98 (38.78%)
    39 / 101 (38.61%)
         occurrences all number
    122
    134
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    14 / 98 (14.29%)
    13 / 101 (12.87%)
         occurrences all number
    20
    13
    Dyspnoea
         subjects affected / exposed
    25 / 98 (25.51%)
    19 / 101 (18.81%)
         occurrences all number
    38
    34
    Pleural effusion
         subjects affected / exposed
    20 / 98 (20.41%)
    5 / 101 (4.95%)
         occurrences all number
    28
    6
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 98 (4.08%)
    11 / 101 (10.89%)
         occurrences all number
    5
    15
    Dysgeusia
         subjects affected / exposed
    12 / 98 (12.24%)
    6 / 101 (5.94%)
         occurrences all number
    22
    13
    Headache
         subjects affected / exposed
    12 / 98 (12.24%)
    9 / 101 (8.91%)
         occurrences all number
    15
    10
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    33 / 98 (33.67%)
    36 / 101 (35.64%)
         occurrences all number
    73
    67
    Abdominal pain upper
         subjects affected / exposed
    10 / 98 (10.20%)
    18 / 101 (17.82%)
         occurrences all number
    18
    26
    Ascites
         subjects affected / exposed
    8 / 98 (8.16%)
    6 / 101 (5.94%)
         occurrences all number
    16
    9
    Constipation
         subjects affected / exposed
    33 / 98 (33.67%)
    28 / 101 (27.72%)
         occurrences all number
    46
    39
    Diarrhoea
         subjects affected / exposed
    41 / 98 (41.84%)
    29 / 101 (28.71%)
         occurrences all number
    122
    69
    Dry mouth
         subjects affected / exposed
    5 / 98 (5.10%)
    6 / 101 (5.94%)
         occurrences all number
    5
    6
    Dyspepsia
         subjects affected / exposed
    9 / 98 (9.18%)
    7 / 101 (6.93%)
         occurrences all number
    16
    9
    Flatulence
         subjects affected / exposed
    6 / 98 (6.12%)
    11 / 101 (10.89%)
         occurrences all number
    6
    12
    Nausea
         subjects affected / exposed
    65 / 98 (66.33%)
    49 / 101 (48.51%)
         occurrences all number
    139
    89
    Stomatitis
         subjects affected / exposed
    9 / 98 (9.18%)
    8 / 101 (7.92%)
         occurrences all number
    13
    10
    Vomiting
         subjects affected / exposed
    40 / 98 (40.82%)
    34 / 101 (33.66%)
         occurrences all number
    95
    54
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    3 / 98 (3.06%)
    7 / 101 (6.93%)
         occurrences all number
    6
    13
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    10 / 98 (10.20%)
    7 / 101 (6.93%)
         occurrences all number
    10
    8
    Dry skin
         subjects affected / exposed
    5 / 98 (5.10%)
    3 / 101 (2.97%)
         occurrences all number
    7
    3
    Erythema
         subjects affected / exposed
    5 / 98 (5.10%)
    3 / 101 (2.97%)
         occurrences all number
    7
    3
    Night sweats
         subjects affected / exposed
    6 / 98 (6.12%)
    2 / 101 (1.98%)
         occurrences all number
    6
    2
    Pruritus
         subjects affected / exposed
    6 / 98 (6.12%)
    9 / 101 (8.91%)
         occurrences all number
    8
    12
    Rash
         subjects affected / exposed
    20 / 98 (20.41%)
    14 / 101 (13.86%)
         occurrences all number
    28
    20
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 98 (3.06%)
    6 / 101 (5.94%)
         occurrences all number
    8
    16
    Back pain
         subjects affected / exposed
    8 / 98 (8.16%)
    16 / 101 (15.84%)
         occurrences all number
    10
    19
    Muscloskeletal pain
         subjects affected / exposed
    1 / 98 (1.02%)
    6 / 101 (5.94%)
         occurrences all number
    1
    7
    Pain in extremity
         subjects affected / exposed
    10 / 98 (10.20%)
    5 / 101 (4.95%)
         occurrences all number
    10
    6
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    48 / 98 (48.98%)
    23 / 101 (22.77%)
         occurrences all number
    82
    48
    Hyperglycaemia
         subjects affected / exposed
    9 / 98 (9.18%)
    6 / 101 (5.94%)
         occurrences all number
    31
    15
    Hypokalaemia
         subjects affected / exposed
    12 / 98 (12.24%)
    10 / 101 (9.90%)
         occurrences all number
    19
    15
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    7 / 98 (7.14%)
    5 / 101 (4.95%)
         occurrences all number
    9
    5
    Oral candidiasis
         subjects affected / exposed
    7 / 98 (7.14%)
    5 / 101 (4.95%)
         occurrences all number
    8
    5
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 98 (7.14%)
    3 / 101 (2.97%)
         occurrences all number
    7
    3
    Urinary tract infection
         subjects affected / exposed
    6 / 98 (6.12%)
    1 / 101 (0.99%)
         occurrences all number
    9
    1

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Feb 2013
    This protocol amendment corrects some typographical errors, updates some definitions in section 5.1, provides clarification on blood sampling for CA19-9, provides clarification on PFS assessments, states that the investigator would now directly access the Interactive voice/Web response system (IVRS/IWRS) system should there be a need to break the blind for a participant for safety reasons, and now correctly states that the IDMC board would not share their findings on efficacy with the sponsor at the interim analysis.
    08 Nov 2013
    This protocol amendment removes all references to commercial supply of dasatinib and adds a possible additional analysis once deaths were recorded for up to 90% of participants.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

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