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    Clinical Trial Results:
    Dasatinib in Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemic Subjects Who are Experiencing Clinical Benefit on Current START, CA180039, or CA180043 Protocols: Long Term Safety and Efficacy Analysis.

    Summary
    EudraCT number
    		 2007-003624-37
    Trial protocol
    		 DE   BE   IE   GB   IT   FI   ES   HU  
    Global end of trial date
    12 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jul 2016
    First version publication date
    01 Jul 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CA180-188
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00982488
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Bristol-Myers Squibb International Corporation, Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Dec 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to determine the long term safety and tolerability of dasatinib.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Oct 2007
    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
    Poland: 16
    Country: Number of subjects enrolled
    Spain: 1
    Country: Number of subjects enrolled
    United Kingdom: 13
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Finland: 2
    Country: Number of subjects enrolled
    Germany: 25
    Country: Number of subjects enrolled
    Hungary: 4
    Country: Number of subjects enrolled
    Ireland: 2
    Country: Number of subjects enrolled
    Italy: 17
    Country: Number of subjects enrolled
    Argentina: 6
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    Brazil: 21
    Country: Number of subjects enrolled
    Canada: 19
    Country: Number of subjects enrolled
    Korea, Republic of: 11
    Country: Number of subjects enrolled
    Peru: 7
    Country: Number of subjects enrolled
    Russian Federation: 10
    Country: Number of subjects enrolled
    South Africa: 3
    Country: Number of subjects enrolled
    Switzerland: 2
    Country: Number of subjects enrolled
    Thailand: 2
    Country: Number of subjects enrolled
    United States: 73
    Worldwide total number of subjects
    238
    EEA total number of subjects
    82
    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)
    170
    From 65 to 84 years
    68
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was conducted at 58 sites in 20 countries.

    Pre-assignment
    Screening details
    		 A total of 238 subjects were enrolled: 200 with chronic phase chronic myelogenous leukemia (CML) and 38 with advanced phase disease (34 with accelerated phase CML, 3 with myeloid blast phase CML, and 1 with Philadelphia chromosome positive acute lymphoblastic leukemia.) All but 1 CML subject, who no longer met study criteria, received treatment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    This study was an open-label study, hence no blinding was implemented.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dasatinib 50 mg QD to 120 mg BID, Chronic Phase
    Arm description
    		 Subjects with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Subjects continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Subjects received study medication until disease progression, unacceptable toxicity, failure to serve subject's best interest, withdrawal of consent, or study closure.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dasatinib
    Investigational medicinal product code
    BMS-354825
    Other name
    Sprycel
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dasatinib 20-mg and 50-mg tablets were orally administered to meet daily dose of 20mg BID/40mg QD to maximum 100 mg BID/180 mg QD.

    Arm title
    		 Imatinib, 400 mg BID, Chronic Phase
    Arm description
    		 Subjects with chronic phase disease received 400 mg of imatinib BID. Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the subject had not previously received that dose prior to entry into CA180-017. Subjects received study medication until disease progression, unacceptable toxicity, failure to serve subject's best interest, withdrawal of consent, or study closure.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Imatinib
    Investigational medicinal product code
    Other name
    Gleevec/Glivec
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Imatinib 100-mg and 400-mg tablets were orally administered to meet daily dose of 300 or 400 mg.

    Arm title
    		 Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP
    Arm description
    		 Subjects with advanced phase disease, accelerated phase (AP) were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Subjects continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Subjects received study medication until disease progression, unacceptable toxicity, failure to serve subject's best interest, withdrawal of consent, or study closure.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dasatinib
    Investigational medicinal product code
    BMS-354825
    Other name
    Sprycel
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dasatinib 20-mg and 50-mg tablets were orally administered to meet daily dose of 20mg BID/40mg QD to maximum 100 mg BID/180 mg QD.

    Arm title
    		 Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MPB
    Arm description
    		 Subjects with advanced phase disease, myeloid blast phase (MPB), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Subjects continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Subjects received study medication until disease progression, unacceptable toxicity, failure to serve subject's best interest, withdrawal of consent, or study closure.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dasatinib
    Investigational medicinal product code
    BMS-354825
    Other name
    Sprycel
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dasatinib 20-mg and 50-mg tablets were orally administered to meet daily dose of 20mg BID/40mg QD to maximum 100 mg BID/180 mg QD.

    Arm title
    		 Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL
    Arm description
    		 Subjects with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Subjects continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Subjects received study medication until disease progression, unacceptable toxicity, failure to serve subject's best interest, withdrawal of consent, or study closure.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dasatinib
    Investigational medicinal product code
    BMS-354825
    Other name
    Sprycel
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dasatinib 20-mg and 50-mg tablets were orally administered to meet daily dose of 20mg BID/40mg QD to maximum 100 mg BID/180 mg QD.

    Number of subjects in period 1 [1]
    		Dasatinib 50 mg QD to 120 mg BID, Chronic Phase Imatinib, 400 mg BID, Chronic Phase Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MPB Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL
    Started
    185
    14
    34
    3
    1
    Completed
    0
    0
    0
    0
    0
    Not completed
    185
    14
    34
    3
    1
         Consent withdrawn by subject
    5
    1
    1
    -
    -
         Disease progression
    30
    5
    10
    1
    1
         Poor/noncompliance
    -
    1
    -
    -
    -
         Study drug toxicity
    34
    1
    6
    -
    -
         Death
    11
    -
    2
    -
    -
         Maximum clinical benefit
    1
    1
    1
    -
    -
         Not specified
    15
    1
    3
    1
    -
         Adverse event unrelated to study drug
    5
    1
    -
    -
    -
         Stem cell transplant
    2
    -
    -
    1
    -
         Lost to follow-up
    1
    -
    -
    -
    -
         Administrative reason by sponsor
    81
    3
    11
    -
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial as out of 238 subjects who were enrolled, 237 were treated. 1 subject no longer met study criteria.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dasatinib 50 mg QD to 120 mg BID, Chronic Phase
    Reporting group description
    		 Subjects with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Subjects continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Subjects received study medication until disease progression, unacceptable toxicity, failure to serve subject's best interest, withdrawal of consent, or study closure.

    Reporting group title
    Imatinib, 400 mg BID, Chronic Phase
    Reporting group description
    		 Subjects with chronic phase disease received 400 mg of imatinib BID. Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the subject had not previously received that dose prior to entry into CA180-017. Subjects received study medication until disease progression, unacceptable toxicity, failure to serve subject's best interest, withdrawal of consent, or study closure.

    Reporting group title
    Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP
    Reporting group description
    		 Subjects with advanced phase disease, accelerated phase (AP) were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Subjects continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Subjects received study medication until disease progression, unacceptable toxicity, failure to serve subject's best interest, withdrawal of consent, or study closure.

    Reporting group title
    Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MPB
    Reporting group description
    		 Subjects with advanced phase disease, myeloid blast phase (MPB), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Subjects continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Subjects received study medication until disease progression, unacceptable toxicity, failure to serve subject's best interest, withdrawal of consent, or study closure.

    Reporting group title
    Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL
    Reporting group description
    		 Subjects with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Subjects continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Subjects received study medication until disease progression, unacceptable toxicity, failure to serve subject's best interest, withdrawal of consent, or study closure.

    Reporting group values
    		 Dasatinib 50 mg QD to 120 mg BID, Chronic Phase Imatinib, 400 mg BID, Chronic Phase Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MPB Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL Total
    Number of subjects
    		 185 14 34 3 1 237
    Age categorical
    Units: Subjects
        Younger than 21 years
    		 0 0 0 0 0 0
        21-45 years
    		 46 5 7 0 0 58
        46-65 years
    		 88 5 17 3 1 114
        66-75 years
    		 40 3 9 0 0 52
        Older than 75 years
    		 11 1 1 0 0 13
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 55.7 ( 13 ) 51.5 ( 15.8 ) 56.3 ( 11.2 ) 57.3 ( 3.1 ) 62 ( 0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 91 6 15 2 1 115
        Male
    		 94 8 19 1 0 122
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 167 10 26 2 1 206
        Black/African American
    		 8 0 2 0 0 10
        Asian
    		 7 1 6 0 0 14
        Other
    		 3 3 0 1 0 7

    End points

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    End points reporting groups
    Reporting group title
    Dasatinib 50 mg QD to 120 mg BID, Chronic Phase
    Reporting group description
    		 Subjects with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Subjects continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Subjects received study medication until disease progression, unacceptable toxicity, failure to serve subject's best interest, withdrawal of consent, or study closure.

    Reporting group title
    Imatinib, 400 mg BID, Chronic Phase
    Reporting group description
    		 Subjects with chronic phase disease received 400 mg of imatinib BID. Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the subject had not previously received that dose prior to entry into CA180-017. Subjects received study medication until disease progression, unacceptable toxicity, failure to serve subject's best interest, withdrawal of consent, or study closure.

    Reporting group title
    Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP
    Reporting group description
    		 Subjects with advanced phase disease, accelerated phase (AP) were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Subjects continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Subjects received study medication until disease progression, unacceptable toxicity, failure to serve subject's best interest, withdrawal of consent, or study closure.

    Reporting group title
    Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MPB
    Reporting group description
    		 Subjects with advanced phase disease, myeloid blast phase (MPB), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Subjects continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Subjects received study medication until disease progression, unacceptable toxicity, failure to serve subject's best interest, withdrawal of consent, or study closure.

    Reporting group title
    Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL
    Reporting group description
    		 Subjects with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Subjects continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Subjects received study medication until disease progression, unacceptable toxicity, failure to serve subject's best interest, withdrawal of consent, or study closure.

    Primary: Number of Subjects With Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest and Death

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    End point title
    		 Number of Subjects With Serious Adverse Events (SAEs), Related SAEs, Adverse Events (AEs) Leading to Discontinuation, Related AEs Leading to Discontinuation, Related AEs, and Related AEs of Special Interest and Death [1]
    End point description
    AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Related=drug-related; having certain, probable, possible, or unknown relationship to study drug. The analysis was performed in all the subjects who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Day 1 of treatment through a maximum of 82 months plus 30 days
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive summary statistics were planned for this outcome measure. 
    End point values
    		 Dasatinib 50 mg QD to 120 mg BID, Chronic Phase Imatinib, 400 mg BID, Chronic Phase Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MPB Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL
    Number of subjects analysed
    185
    14
    34
    3
    1
    Units: Subjects
        All deaths
    22
    0
    4
    0
    0
        Deaths within 30 days of last dose
    9
    0
    2
    0
    0
        SAEs
    57
    3
    15
    1
    1
        Drug-related SAEs
    28
    2
    9
    0
    0
        AEs leading to discontinuation
    39
    2
    10
    0
    1
        Drug-related AEs leading to discontinuation
    29
    1
    8
    0
    0
        Drug-related AEs
    140
    7
    27
    2
    0
        Drug-related AEs of special interest
    111
    4
    21
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 of treatment through a maximum of 82 months plus 30 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Dasatinib 50 mg QD to 120 mg BID, Chronic Phase
    Reporting group description
    		 Subjects with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Subjects continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Subjects received study medication until disease progression, unacceptable toxicity, failure to serve subject's best interest, withdrawal of consent, or study closure.

    Reporting group title
    Imatinib, 400 mg BID, Chronic Phase
    Reporting group description
    		 Subjects with chronic phase disease received 400 mg of imatinib BID. Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the subject had not previously received that dose prior to entry into CA180-017. subjects received study medication until disease progression, unacceptable toxicity, failure to serve subject's best interest, withdrawal of consent, or study closure.

    Reporting group title
    Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP
    Reporting group description
    		 Subjects with advanced phase disease, accelerated phase (AP) were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Subjects continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Subjects received study medication until disease progression, unacceptable toxicity, failure to serve subject's best interest, withdrawal of consent, or study closure.

    Reporting group title
    Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MPB
    Reporting group description
    		 Subjects with advanced phase disease, myeloid blast phase (MPB), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Subjects continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Subjects received study medication until disease progression, unacceptable toxicity, failure to serve subject's best interest, withdrawal of consent, or study closure.

    Reporting group title
    Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL
    Reporting group description
    		 Subjects with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Subjects continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Subjects received study medication until disease progression, unacceptable toxicity, failure to serve subject's best interest, withdrawal of consent, or study closure.

    Serious adverse events
    		 Dasatinib 50 mg QD to 120 mg BID, Chronic Phase Imatinib, 400 mg BID, Chronic Phase Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MPB Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL
    Total subjects affected by serious adverse events
         subjects affected / exposed
    57 / 185 (30.81%)
    3 / 14 (21.43%)
    15 / 34 (44.12%)
    1 / 3 (33.33%)
    1 / 1 (100.00%)
         number of deaths (all causes)
    22
    0
    4
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute lymphocytic leukaemia recurrent
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 14 (0.00%)
    1 / 34 (2.94%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer recurrent
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 14 (0.00%)
    1 / 34 (2.94%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant neoplasm progression
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tumour flare
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 14 (0.00%)
    1 / 34 (2.94%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic myeloid leukaemia
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 14 (0.00%)
    1 / 34 (2.94%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasm
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 14 (0.00%)
    1 / 34 (2.94%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Oophorectomy bilateral
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Disease progression
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 14 (0.00%)
    1 / 34 (2.94%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    1 / 34 (2.94%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Effusion
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 14 (0.00%)
    1 / 34 (2.94%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 14 (0.00%)
    1 / 34 (2.94%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    5 / 185 (2.70%)
    0 / 14 (0.00%)
    1 / 34 (2.94%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    2 / 185 (1.08%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Elderly
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary arterial hypertension
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemothorax
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    13 / 185 (7.03%)
    1 / 14 (7.14%)
    3 / 34 (8.82%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    16 / 16
    0 / 1
    3 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    3 / 185 (1.62%)
    0 / 14 (0.00%)
    3 / 34 (8.82%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 0
    3 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    2 / 185 (1.08%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nasal septum perforation
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 14 (0.00%)
    1 / 34 (2.94%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung infiltration
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Procedural haemorrhage
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transfusion reaction
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 14 (0.00%)
    1 / 34 (2.94%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Splenic rupture
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    2 / 185 (1.08%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bradyarrhythmia
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    1 / 34 (2.94%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 14 (0.00%)
    1 / 34 (2.94%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Left ventricular dysfunction
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    1 / 34 (2.94%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    2 / 185 (1.08%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 185 (0.54%)
    1 / 14 (7.14%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    VIIth nerve paralysis
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 14 (0.00%)
    1 / 34 (2.94%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Retinal artery occlusion
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vision blurred
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 185 (1.08%)
    1 / 14 (7.14%)
    1 / 34 (2.94%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestinal haemorrhage
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal distension
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 14 (0.00%)
    1 / 34 (2.94%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    2 / 185 (1.08%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Volvulus
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    1 / 34 (2.94%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    2 / 185 (1.08%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 14 (7.14%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure acute
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    1 / 1 (100.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bone pain
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 14 (0.00%)
    1 / 34 (2.94%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal pain
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Groin pain
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    2 / 185 (1.08%)
    0 / 14 (0.00%)
    1 / 34 (2.94%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    3 / 185 (1.62%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    3 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    5 / 185 (2.70%)
    0 / 14 (0.00%)
    3 / 34 (8.82%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    2 / 7
    0 / 0
    1 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Pseudomembranous colitis
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 14 (7.14%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    3 / 185 (1.62%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obesity
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Dasatinib 50 mg QD to 120 mg BID, Chronic Phase Imatinib, 400 mg BID, Chronic Phase Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MPB Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    138 / 185 (74.59%)
    10 / 14 (71.43%)
    24 / 34 (70.59%)
    2 / 3 (66.67%)
    0 / 1 (0.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    12 / 185 (6.49%)
    0 / 14 (0.00%)
    3 / 34 (8.82%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    14
    0
    3
    0
    0
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    25 / 185 (13.51%)
    1 / 14 (7.14%)
    4 / 34 (11.76%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    32
    1
    4
    0
    0
    Face oedema
         subjects affected / exposed
    2 / 185 (1.08%)
    1 / 14 (7.14%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    Fatigue
         subjects affected / exposed
    25 / 185 (13.51%)
    1 / 14 (7.14%)
    3 / 34 (8.82%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    27
    1
    3
    1
    0
    Pyrexia
         subjects affected / exposed
    15 / 185 (8.11%)
    1 / 14 (7.14%)
    1 / 34 (2.94%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    17
    1
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    67 / 185 (36.22%)
    1 / 14 (7.14%)
    17 / 34 (50.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    93
    1
    19
    1
    0
    Dyspnoea
         subjects affected / exposed
    33 / 185 (17.84%)
    0 / 14 (0.00%)
    5 / 34 (14.71%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    44
    0
    9
    0
    0
    Cough
         subjects affected / exposed
    20 / 185 (10.81%)
    0 / 14 (0.00%)
    4 / 34 (11.76%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    21
    0
    4
    0
    0
    Dyspnoea exertional
         subjects affected / exposed
    8 / 185 (4.32%)
    0 / 14 (0.00%)
    3 / 34 (8.82%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    9
    0
    4
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    6 / 185 (3.24%)
    1 / 14 (7.14%)
    1 / 34 (2.94%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    6
    1
    1
    1
    0
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 14 (0.00%)
    1 / 34 (2.94%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 14 (7.14%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 185 (1.08%)
    0 / 14 (0.00%)
    2 / 34 (5.88%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    Blood fibrinogen decreased
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 14 (7.14%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Blood bilirubin
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 14 (0.00%)
    2 / 34 (5.88%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Lipase increased
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 14 (7.14%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Cardiac disorders
    Diastolic dysfunction
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Nodal arrhythmia
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 14 (7.14%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    13 / 185 (7.03%)
    0 / 14 (0.00%)
    2 / 34 (5.88%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    15
    0
    2
    0
    0
    Neuropathy peripheral
         subjects affected / exposed
    2 / 185 (1.08%)
    1 / 14 (7.14%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    Headache
         subjects affected / exposed
    14 / 185 (7.57%)
    1 / 14 (7.14%)
    1 / 34 (2.94%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    17
    1
    2
    0
    0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    8 / 185 (4.32%)
    1 / 14 (7.14%)
    3 / 34 (8.82%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    17
    3
    4
    0
    0
    Neutropenia
         subjects affected / exposed
    8 / 185 (4.32%)
    1 / 14 (7.14%)
    3 / 34 (8.82%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    12
    1
    5
    0
    0
    Gastrointestinal disorders
    Dyspepsia
         subjects affected / exposed
    2 / 185 (1.08%)
    1 / 14 (7.14%)
    2 / 34 (5.88%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    2
    2
    0
    0
    Constipation
         subjects affected / exposed
    9 / 185 (4.86%)
    1 / 14 (7.14%)
    1 / 34 (2.94%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    9
    1
    1
    0
    0
    Abdominal distension
         subjects affected / exposed
    3 / 185 (1.62%)
    1 / 14 (7.14%)
    2 / 34 (5.88%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    3
    1
    4
    0
    0
    Diarrhoea
         subjects affected / exposed
    19 / 185 (10.27%)
    2 / 14 (14.29%)
    2 / 34 (5.88%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    32
    3
    2
    2
    0
    Nausea
         subjects affected / exposed
    8 / 185 (4.32%)
    0 / 14 (0.00%)
    2 / 34 (5.88%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    10
    0
    2
    0
    0
    Vomiting
         subjects affected / exposed
    4 / 185 (2.16%)
    3 / 14 (21.43%)
    1 / 34 (2.94%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    4
    4
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    2 / 185 (1.08%)
    1 / 14 (7.14%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    Rash
         subjects affected / exposed
    31 / 185 (16.76%)
    0 / 14 (0.00%)
    4 / 34 (11.76%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    34
    0
    5
    0
    0
    Pruritus
         subjects affected / exposed
    5 / 185 (2.70%)
    0 / 14 (0.00%)
    2 / 34 (5.88%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    5
    0
    2
    1
    0
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    2 / 185 (1.08%)
    1 / 14 (7.14%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    3
    1
    0
    0
    0
    Renal failure
         subjects affected / exposed
    1 / 185 (0.54%)
    1 / 14 (7.14%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Haematuria
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 14 (0.00%)
    2 / 34 (5.88%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    12 / 185 (6.49%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    12
    0
    0
    0
    0
    Osteoarthritis
         subjects affected / exposed
    3 / 185 (1.62%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    3
    0
    0
    1
    0
    Myalgia
         subjects affected / exposed
    8 / 185 (4.32%)
    1 / 14 (7.14%)
    1 / 34 (2.94%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    10
    1
    1
    0
    0
    Osteoporosis
         subjects affected / exposed
    2 / 185 (1.08%)
    1 / 14 (7.14%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    Arthralgia
         subjects affected / exposed
    14 / 185 (7.57%)
    0 / 14 (0.00%)
    1 / 34 (2.94%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    14
    0
    1
    1
    0
    Back pain
         subjects affected / exposed
    11 / 185 (5.95%)
    1 / 14 (7.14%)
    1 / 34 (2.94%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    11
    1
    1
    0
    0
    Infections and infestations
    Viral infection
         subjects affected / exposed
    2 / 185 (1.08%)
    1 / 14 (7.14%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    2 / 185 (1.08%)
    1 / 14 (7.14%)
    1 / 34 (2.94%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    3
    1
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    10 / 185 (5.41%)
    1 / 14 (7.14%)
    1 / 34 (2.94%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    15
    1
    1
    0
    0
    Fungal skin infection
         subjects affected / exposed
    1 / 185 (0.54%)
    1 / 14 (7.14%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 185 (0.54%)
    1 / 14 (7.14%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Localised infection
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 14 (0.00%)
    2 / 34 (5.88%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    7 / 185 (3.78%)
    1 / 14 (7.14%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    7
    1
    0
    0
    0
    Peritonsillar abscess
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 14 (0.00%)
    0 / 34 (0.00%)
    1 / 3 (33.33%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Sinusitis
         subjects affected / exposed
    2 / 185 (1.08%)
    1 / 14 (7.14%)
    0 / 34 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    2
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Dec 2008
    The required language regarding Serious Breach Identification and adverse event reporting were added.
    24 Nov 2009
    The international 24 hour telephone number was updated, quantitative polymerase chain reaction sample collection/analysis was removed, Imatinib dosing guidance for subjects with renal impairment was updated, and the serious adverse event submission process was updated.

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

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