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    Clinical Trial Results:
    A PHASE IV, OPEN-LABEL, MULTICENTER STUDY OF DASATINIB IN CHRONIC-PHASE CHRONIC MYELOID LEUKEMIA (CP-CML) PATIENTS WITH CHRONIC LOW-GRADE NONHEMATOLOGIC TOXICITY TO IMATINIB

    Summary
    EudraCT number
    2011-006180-21
    Trial protocol
    IT   DE  
    Global end of trial date
    01 Oct 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    14 Oct 2016
    First version publication date
    14 Oct 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CA180-400
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01660906
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chausée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb International Corporation, clinical.trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb International Corporation, 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
    01 Oct 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Oct 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to assess the frequency of reduction in grade (Grade 2 to 1) or resolution of imatinib-related chronic Grade 1 or Grade 2 non-hematologic adverse events (AEs) within 3 months after switch to dasatinib in subjects with Chronic-Phase Chronic Myeloid Leukemia (CP-CML).
    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
    Adults subjects diagnosed with CP-CML that had achieved an optimal response to imatinib (≤ 400 mg/day treatment) who had Grade 1 or 2 non-hematologic AEs persisting for at least 2 months, or recurring at least 3 times in the preceding 12 months, despite best supportive care.
    Evidence for comparator
    -
    Actual start date of recruitment
    31 Oct 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 3
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Italy: 9
    Country: Number of subjects enrolled
    Korea, Republic of: 22
    Worldwide total number of subjects
    39
    EEA total number of subjects
    14
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    27
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 22 sites in France, Germany, Italy, Republic of Korea, and the United States.

    Pre-assignment
    Screening details
    A total of 39 subjects were enrolled and treated.

    Period 1
    Period 1 title
    Dasatinib (100 mg) (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Dasatinib (100 mg)
    Arm description
    Subjects that were previously on an imatinib therapy were treated with a 100 mg tablet of dasatinib taken orally once a day for up to 12 months while on study.
    Arm type
    Experimental

    Investigational medicinal product name
    Dasatinib
    Investigational medicinal product code
    BMS-354825
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered with dasatinib 100 mg tablet orally once daily for up to 12 months while on study.

    Number of subjects in period 1
    Dasatinib (100 mg)
    Started
    39
    Completed
    36
    Not completed
    3
         Discontinued due to study drug toxicity
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dasatinib (100 mg)
    Reporting group description
    Subjects that were previously on an imatinib therapy were treated with a 100 mg tablet of dasatinib taken orally once a day for up to 12 months while on study.

    Reporting group values
    Dasatinib (100 mg) Total
    Number of subjects
    39 39
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    27 27
        From 65-84 years
    12 12
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    55.1 ± 15.13 -
    Gender categorical
    Units: Subjects
        Female
    18 18
        Male
    21 21
    Race/Ethnicity
    Units: Subjects
        White
    12 12
        Black or African American
    1 1
        American Indian or Alaska Native
    0 0
        Asian
    22 22
        Native Hawaiian or Other Pacific Islander
    0 0
        Other
    4 4
    Imatinib dose at baseline
    Units: Subjects
        < 400 milligrams
    19 19
        400 milligrams
    20 20
    Best baseline response
    MR4.5, 4.5- log reduction in gene breakpoint cluster region -abelson murine leukemia viral oncogene (BCR-ABL) transcript from the standardized baseline (0.0032% IS); Major Molecular Response (MMR). Complete cytogenetic response (CCyR). Partial cytogenetic response (PCyR).
    Units: Subjects
        MR4.5
    10 10
        MMR
    20 20
        CCyR
    4 4
        PCyR
    2 2
        Cytogenetic Test Not Performed
    3 3
    Median time since CML-CP diagnosis
    CML-CP
    Units: months
        median (full range (min-max))
    51.3 (3.9 to 214.6) -
    Median duration of imatinib
    Units: months
        median (full range (min-max))
    51.2 (3.1 to 160.4) -

    End points

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    End points reporting groups
    Reporting group title
    Dasatinib (100 mg)
    Reporting group description
    Subjects that were previously on an imatinib therapy were treated with a 100 mg tablet of dasatinib taken orally once a day for up to 12 months while on study.

    Primary: Number of Imatinib-related Adverse Events (AEs) That Were Resolved, Improved, Remained Unchanged, or Worsened After 3 Months of Dasatinib Treatment

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    End point title
    Number of Imatinib-related Adverse Events (AEs) That Were Resolved, Improved, Remained Unchanged, or Worsened After 3 Months of Dasatinib Treatment [1]
    End point description
    Prior to dasatinib treatment, subjects were on imatinib therapy and reported 121 imatinib-related Grade 1 or 2 (Grade1/2) AEs. Dasatinib treatment was administered and its impact on the imatinib-related Grade 1/2 AEs was assessed. Imatinib-related chronic AEs were defined as Grade 1 or 2 non-hematologic AEs persisting for at least 2 months or recurring at least 3 times in the preceding 12 months, despite best supportive care. The severity of an adverse event is ranked based on grades that range from 1 to 4 according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4= Potentially Life-threatening or disabling. Resolved, AE no longer present or resolution of imatinib-related chronic Grade 1 or Grade 2 non-hematologic AEs. Improved, AE grade reduced from Grade 2 to Grade 1. Unchanged, AE did not improve or worsen or no change in grade. Worsened, grade increased. All treated subjects.
    End point type
    Primary
    End point timeframe
    From screening up to 3 months after switch to dasatinib
    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 statistics was planned for this safety end-point.
    End point values
    Dasatinib (100 mg)
    Number of subjects analysed
    39
    Units: Number of events
        Resolved
    91
        Improved
    2
        Unchanged
    27
        Worsened
    1
    No statistical analyses for this end point

    Secondary: Change From Baseline in Subject Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory (MDASI) CML Score After Switching to Dasatinib

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    End point title
    Change From Baseline in Subject Reported CML Symptom Severity and Interference by MD Anderson Symptom Inventory (MDASI) CML Score After Switching to Dasatinib
    End point description
    The MDASI-CML is a validated questionnaire completed by study subjects to assess symptom severity and symptom interference on daily function. These categories are divided into 5 domain summary scores: Core Symptom Severity Score, Interference Score, Symptom Severity Score, CML-Specific Symptom Severity Score, and 5 Most Severe Symptom Score. Scores were evaluated at baseline and after switching to dasatinib on a range from 1 to 10; 1=not present/did not interfere, 10=as bad as you can imagine/interfered completely. All treated subjects. Small "n" refers to the total number of subjects that responded to the survey at the specified interval.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 3, 6, and 12
    End point values
    Dasatinib (100 mg)
    Number of subjects analysed
    39
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Core Symptom Severity Score, Month 3; n=37
    -1.35 ± 1.78
        Core Symptom Severity Score, Month 6; n=36
    -1.44 ± 1.84
        Core Symptom Severity Score, Month 12; n=37
    -1.06 ± 1.87
        Interference Score, Month 3; n=37
    -1.24 ± 2.36
        Interference Score, Month 6; n=35
    -1.28 ± 2.45
        Interference Score, Month 12; n=36
    -1.3 ± 2.56
        Symptom Severity Score, Month 3; n=37
    -1.73 ± 1.8
        Symptom Severity Score, Month 6; n=36
    -1.8 ± 1.85
        Symptom Severity Score, Month 12; n=37
    -1.46 ± 1.75
        CML-specific Symptom Severity Score, Month 3; n=37
    -2.52 ± 2.35
        CML-specific Symptom Severity Score, Month 6; n=36
    -2.6 ± 2.15
        CML-specific Symptom Severity Score,Month 12; n=36
    -2.24 ± 1.87
        5 Most Severe Symptom Score, Month 3; n=37
    -1.61 ± 1.76
        5 Most Severe Symptom Score, Month 6; n=36
    -1.69 ± 1.84
        5 Most Severe Symptom Score, Month 12; n=37
    -1.43 ± 1.72
    No statistical analyses for this end point

    Secondary: Change From Baseline in Subject Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib at Month 6 and 12

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    End point title
    Change From Baseline in Subject Reported Quality of Life Measurements by The European Organization for Research and Treatment of Cancer - Quality of Life (QoL) Questionnaire (EORTC QLQ) Score After Switching to Dasatinib at Month 6 and 12
    End point description
    The EORTC QLQ-C30 questionnaire was completed by study subjects to assess quality of life through nine multi-item scales: five functional scales (physical, role, cognitive, emotional and social functioning); three symptom scales (fatigue, pain and nausea/vomiting); and a global health status/QoL scale. Six single-item scales were included (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). All scales and single-item measures were evaluated at baseline and after switching to Dasatinib as an average raw score that was standardized by transformation, so that final scores were on a range in score from 0 to 100. A high score for a functional scale represented a healthy level of functioning, a high score for the global health status/QoL represented a high QoL, but a high score for a symptom scale represented a high level of problematic symptomatology. All treated subjects. Small "n" refers to total number of subjects that responded to the questionnaire.
    End point type
    Secondary
    End point timeframe
    Baseline, Month 6 , Month 12
    End point values
    Dasatinib (100 mg)
    Number of subjects analysed
    39
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Global Health Status/QOL, Month 6 (n=36)
    0.46 ± 23.733
        Global Health Status/QOL, Month 12 (n=35)
    2.86 ± 27.782
        Cognitive Functioning, Month 6 (n=35)
    1.9 ± 20.119
        Cognitive Functioning, Month 12 (n=35)
    1.43 ± 18.245
        Emotional Functioning, Month 6 (n=35)
    11.19 ± 23.216
        Emotional Functioning, Month 12 (n=35)
    12.62 ± 25.595
        Physical Functioning, Month 6 (n=36)
    -1.67 ± 10.923
        Physical Functioning, Month 12 (n=36)
    0.74 ± 19.241
        Role Functioning, Month 6 (n=36)
    -4.17 ± 27.422
        Role Functioning, Month 12 (n=36)
    2.78 ± 23.401
        Social Functioning, Month 6 (n=35)
    13.81 ± 26.036
        Social Functioning, Month 12 (n=35)
    14.76 ± 24.512
        Fatigue, Month 6 (n=36)
    -6.79 ± 20.102
        Fatigue, Month 12 (n=36)
    -8.33 ± 21.639
        Nausea and Vomiting, Month 6 (n=36)
    -9.72 ± 31.966
        Nausea and Vomiting, Month 12 (n=36)
    -4.63 ± 30.76
        Pain, Month 6 (n=36)
    -2.78 ± 38.318
        Pain, Month 12 (n=36)
    -8.8 ± 25.35
        Appetite Loss, Month 6 (n=35)
    1.9 ± 29.085
        Appetite Loss, Month 12 (n=36)
    1.85 ± 29.755
        Constipation, Month 6 (n=36)
    -0.93 ± 28.156
        Constipation, Month 12 (n=35)
    8.57 ± 23.351
        Diarrhoea, Month 6 (n=36)
    0 ± 36.515
        Diarrhoea, Month 12 (n=35)
    -2.86 ± 40.722
        Dyspnoea, Month 6 (n=36)
    5.56 ± 36.947
        Dyspnoea, Month 12 (n=36)
    9.26 ± 39.53
        Financial Difficulties, Month 6 (n=35)
    -10.48 ± 21.038
        Financial Difficulties, Month 12 (n=35)
    -13.33 ± 18.436
        Insomnia, Month 6 (n=36)
    0.93 ± 42.528
        Insomnia, Month 12 (n=36)
    -1.85 ± 38.991
    No statistical analyses for this end point

    Secondary: Number of Subjects With at least One AE, Discontinuations Due to AE, Treatment-related AE, Serious Adverse Event (SAE), Treatment-related SAE, or Death as an Outcome

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    End point title
    Number of Subjects With at least One AE, Discontinuations Due to AE, Treatment-related AE, Serious Adverse Event (SAE), Treatment-related SAE, or Death as an Outcome
    End point description
    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. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Treatment-related=having certain, probable, possible, or missing relationship to study drug, dasatinib. All treated subjects.
    End point type
    Secondary
    End point timeframe
    SAEs: From screening period and within 30 days of discontinuation of dosing. AEs: From first-treatment dose to 12 months
    End point values
    Dasatinib (100 mg)
    Number of subjects analysed
    39
    Units: Subjects
        At least 1 AE
    37
        Discontinuations due to AE
    3
        Treatment-related AEs
    34
        SAEs
    11
        Treatment-related SAEs
    3
        Death
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With at Least 1 Imatinib-related Grade 1 or Grade 2 Chronic Adverse Events (AEs) That Improved Without Worsening Within 3 Months of Switching to Dasatinib

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    End point title
    Percentage of Subjects With at Least 1 Imatinib-related Grade 1 or Grade 2 Chronic Adverse Events (AEs) That Improved Without Worsening Within 3 Months of Switching to Dasatinib
    End point description
    The percentage of subjects is based on the number that had pre-existing Imatinib-related AEs. Subjects with reduction or improvement of at least 1 Imatinib-related Grade 1 or Grade 2 chronic AE, without a worsening of any Imatinib-related, chronic adverse events after dasatinib treatment were assessed. The severity of an adverse event is ranked based on grades that range from 1 to 4. Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4= Potentially Life-threatening or disabling. Improved, AE grade reduced from Grade 2 to Grade 1. Worsened, Grade Increased. Confidence interval from Clopper-Pearson method. All treated subjects.
    End point type
    Secondary
    End point timeframe
    3 months
    End point values
    Dasatinib (100 mg)
    Number of subjects analysed
    39 [2]
    Units: Percentage of participants
        number (confidence interval 95%)
    87.1 (72.5 to 95.7)
    Notes
    [2] - All treated subjects.
    No statistical analyses for this end point

    Other pre-specified: Number of Subjects With a Major Molecular Response (MMR) and MR 4.5 After Switching to Dasatinib

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    End point title
    Number of Subjects With a Major Molecular Response (MMR) and MR 4.5 After Switching to Dasatinib
    End point description
    Molecular responses were assessed at 6 and 12 months after switching to dasatinib to determine if these baseline responses could be maintained. All treated subjects.
    End point type
    Other pre-specified
    End point timeframe
    Month 6, Month 12
    End point values
    Dasatinib (100 mg)
    Number of subjects analysed
    39
    Units: Subjects
        MR4.5, Month 6
    18
        MR4.5, Month 12
    22
        MMR, Month 6
    13
        MMR, Month 12
    13
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Date of fist dose of study drug to 30 days post discontinuation of the last dose, up to October 2015
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Dasatinib (100 mg)
    Reporting group description
    Subjects that were previously on an imatinib therapy were treated with a 100 mg tablet of dasatinib taken orally once a day for up to 12 months while on study

    Serious adverse events
    Dasatinib (100 mg)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 39 (28.21%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Rib fracture
         subjects affected / exposed
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary arterial hypertension
         subjects affected / exposed
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Anal fissure
         subjects affected / exposed
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Dasatinib (100 mg)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 39 (92.31%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    2
    Blood creatinine increased
         subjects affected / exposed
    3 / 39 (7.69%)
         occurrences all number
    6
    Blood urea increased
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    2
    Cardiac disorders
    Left ventricular hypertrophy
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    2
    Pericardial effusion
         subjects affected / exposed
    3 / 39 (7.69%)
         occurrences all number
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 39 (15.38%)
         occurrences all number
    7
    Dyspnoea
         subjects affected / exposed
    10 / 39 (25.64%)
         occurrences all number
    13
    Dysphonia
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    2
    Pulmonary hypertension
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    2
    Pleural effusion
         subjects affected / exposed
    10 / 39 (25.64%)
         occurrences all number
    17
    Rhinitis allergic
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 39 (12.82%)
         occurrences all number
    13
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 39 (10.26%)
         occurrences all number
    5
    Headache
         subjects affected / exposed
    15 / 39 (38.46%)
         occurrences all number
    19
    Paraesthesia
         subjects affected / exposed
    3 / 39 (7.69%)
         occurrences all number
    4
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    2
    Fatigue
         subjects affected / exposed
    10 / 39 (25.64%)
         occurrences all number
    15
    Face oedema
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    2
    General physical health deterioration
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    3
    Pyrexia
         subjects affected / exposed
    6 / 39 (15.38%)
         occurrences all number
    6
    Psychiatric disorders
    Depression
         subjects affected / exposed
    3 / 39 (7.69%)
         occurrences all number
    3
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    4 / 39 (10.26%)
         occurrences all number
    4
    Diarrhoea
         subjects affected / exposed
    11 / 39 (28.21%)
         occurrences all number
    16
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    2
    Nausea
         subjects affected / exposed
    8 / 39 (20.51%)
         occurrences all number
    8
    Vomiting
         subjects affected / exposed
    3 / 39 (7.69%)
         occurrences all number
    3
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    4 / 39 (10.26%)
         occurrences all number
    5
    Rash
         subjects affected / exposed
    10 / 39 (25.64%)
         occurrences all number
    13
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
         subjects affected / exposed
    3 / 39 (7.69%)
         occurrences all number
    5
    Arthralgia
         subjects affected / exposed
    6 / 39 (15.38%)
         occurrences all number
    9
    Myalgia
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    3
    Tendonitis
         subjects affected / exposed
    2 / 39 (5.13%)
         occurrences all number
    2
    Pain in extremity
         subjects affected / exposed
    3 / 39 (7.69%)
         occurrences all number
    8
    Metabolism and nutrition disorders
    Hyperuricaemia
         subjects affected / exposed
    3 / 39 (7.69%)
         occurrences all number
    5
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 39 (7.69%)
         occurrences all number
    4

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Aug 2012
    This protocol required subject to have the ability to complete patient reported outcome measure; the changes to this protocol in the Informed Consent and Inclusion/Exclusion Criteria sections reflected this requirement. Parameters regarding fluorescence in situ hybridization (FISH) testing were clarified and added to ensure accurate and feasible testing procedures for this study. The differences between disease progression and treatment failure were differentiated.
    21 Nov 2012
    The Purpose of this amendment was to: Chest x-rays are not considered to be standard of care in Germany. Therefore, this Amendment is designed to remove the requirement of pre-specified chest x-rays and allow the testing to be completed as clinically indicated. The exclusion criterion of pleural effusion is also changed to known pleural effusion as a result of this change. These changes will immediately affect all patients in the study sites located in Germany. Also, added the address in Belgium on the cover page.
    09 Oct 2013
    Based on an analysis of the BMS Dasatinib safety database (CARES) and a revision to an internal BMS directive related to “Women of Childbearing Potential (WOCBP) in clinical trials”, this protocol was amended to adjust the frequency of pregnancy testing for sexually active female subjects of childbearing potential to monthly pregnancy testing. Additional changes related to this initiative were: • updated language related to WOCBP to harmonize with the new BMS directive including requiring 2 highly effective forms of birth control • defined highly effective forms of birth control • adjusted language related to sexually active fertile men with WOCBP partners and adapt the length of birth control to be used after the last dose of investigational product (90 days). Finally, an appendix was added to specify criteria for response required for study enrollment and clarifications were added to the time and events schedule.

    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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