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    Clinical Trial Results:
    A Phase 1 Study of BMS-354825 (Dasatinib) in Children with Recurrent/Refractory Solid Tumors or Imatinib Resistant Ph+ Leukemia. ADVL0516

    Summary
    EudraCT number
    		 2010-022945-52
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    07 Feb 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Nov 2017
    First version publication date
    04 Nov 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CA180-038
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00316953
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Bristol Myers Squibb: CA180-038
    Sponsors
    Sponsor organisation name
    Children's Oncology Group
    Sponsor organisation address
    3615 Civic Center Blvd., Philadelphia, United States, 19104
    Public contact
    Richard Aplenc, Study Chair, The Children's Hospital of Philadelphia, 1 267426 7252, raplenc@mail.med.upenn.edu
    Scientific contact
    Richard Aplenc, Study Chair, The Children's Hospital of Philadelphia, 1 267426 7252, raplenc@mail.med.upenn.edu
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000567-PIP01-09
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 Feb 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Feb 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objectives of the trial were: - Describe and define the toxicities, estimate the MTD, and recommend a Phase 2 dose of dasatinib administered as an oral agent given twice daily in children with refractory solid tumors. - Describe and define the toxicities of dasatinib administered as an oral agent given twice daily in children with imatinib resistant Ph+ leukemia. - Characterize the PK of dasatinib in children with refractory solid tumors and imatinib resistant Ph+ leukemia.
    Protection of trial subjects
    The study was conducted 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
    20 Mar 2006
    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: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    0
    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)
    23
    Adolescents (12-17 years)
    15
    Adults (18-64 years)
    2
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were enrolled at 19 sites in the United States.

    Pre-assignment
    Screening details
    		 A total of 40 subjects were enrolled and treated in the study.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Solid Tumor, pediatric
    Arm description
    		 Dasatinib was administered orally twice daily for 28 days (1 course of therapy). A course could be repeated every 28 days if the subject had stable disease and met pre-specified laboratory criteria. A course could be repeated 24 times, for a total of 24 courses. All subjects were started on 50 mg/m2/dose twice daily (BID). Doses were adjusted based on body surface area (BSA) determined at the beginning of each course. Dose level 1 had a dose of 50 mg/m2/dose BID, Dose level 2 had a dose of 65 mg/m2/dose BID, Dose level 3 had a dose of 85 mg/m2/dose BID, and Dose level 4 had a dose of 110 mg/m2/dose BID
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dasatinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Dasatinib tablets orally at a starting dose of 50 mg/m2 twice daily (BID). Doses were adjusted based on body surface area determined at the beginning of each course. Dose escalation occurred in the solid tumors stratum and the maximum tolerated dose (MTD) for each dose level is as follows: dose level 1 was 50 mg/m2 BID, dose level 2 was 65 mg/m2 BID, dose level 3 was 85 mg/m2 BID, and dose level 4 was 110 mg/m2 BID. If MTD was exceeded at the first dose level, then the subsequent cohort of subjects were treated with 40 mg/m2 BID. Dasatinib was supplied as white to off-white round or biconvex round or oval film-coated tablets in doses of 5 mg, 20 mg, 50 mg, and 70 mg. mg=milligram

    Arm title
    		 Leukemia, pediactric
    Arm description
    		 Dasatinib was administered orally twice daily for 28 days (1 course of therapy). A course could be repeated every 28 days if the subject had stable disease and met pre-specified laboratory criteria. A course could be repeated 24 times, for a total of 24 courses. All subjects were started on 50 mg/m2/dose twice daily (BID). Doses were adjusted based on body surface area (BSA) determined at the beginning of each course. Dose level 1 had a dose of 50 mg/m2/dose BID, Dose level 2 had a dose of 65 mg/m2/dose BID, Dose level 3 had a dose of 85 mg/m2/dose BID, and Dose level 4 had a dose of 110 mg/m2/dose BID
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dasatinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Dasatinib tablets orally at a starting dose of 50 mg/m2 twice daily (BID). Subjects in this stratum dose-escalated one dose below the one under study in solid tumors subjects. If the 50 mg/m2 BID dose was not tolerated in a full cohort of refractory Ph+ leukemia subjects, then the dose was de-escalated to 40 mg/m2 BID in this stratum. Dasatinib was supplied as white to off-white round or biconvex round or oval film-coated tablets in doses of 5 mg, 20 mg, 50 mg, and 70 mg. mg=milligram

    Arm title
    		 Solid tumor, adult
    Arm description
    		 Dasatinib was administered orally twice daily for 28 days (1 course of therapy). A course could be repeated every 28 days if the subject had stable disease and met pre-specified laboratory criteria. A course could be repeated 24 times, for a total of 24 courses. All subjects were started on 50 mg/m2/dose twice daily (BID). Doses were adjusted based on body surface area (BSA) determined at the beginning of each course. Dose level 1 had a dose of 50 mg/m2/dose BID, Dose level 2 had a dose of 65 mg/m2/dose BID, Dose level 3 had a dose of 85 mg/m2/dose BID, and Dose level 4 had a dose of 110 mg/m2/dose BID
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dasatinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Dasatinib tablets orally at a starting dose of 50 mg/m2 twice daily (BID). Doses were adjusted based on body surface area determined at the beginning of each course. Dose escalation occurred in the solid tumors stratum and the maximum tolerated dose (MTD) for each dose level is as follows: dose level 1 was 50 mg/m2 BID, dose level 2 was 65 mg/m2 BID, dose level 3 was 85 mg/m2 BID, and dose level 4 was 110 mg/m2 BID. If MTD was exceeded at the first dose level, then the subsequent cohort of subjects were treated with 40 mg/m2 BID. Dasatinib was supplied as white to off-white round or biconvex round or oval film-coated tablets in doses of 5 mg, 20 mg, 50 mg, and 70 mg. mg=milligram

    Number of subjects in period 1
    		Solid Tumor, pediatric Leukemia, pediactric Solid tumor, adult
    Started
    27
    11
    2
    Completed
    0
    0
    0
    Not completed
    27
    11
    2
         Completion of protocol planned therapy
    -
    2
    -
         Adverse events requiring removal from theraphy
    5
    -
    -
         Adverse events requiring removal from therapy
    -
    2
    -
         Death on treatment
    -
    -
    1
         Clinical or radiographic disease progression
    15
    1
    -
         Phycisian determined non-compliance
    -
    1
    -
         Refusal of further protocol therapy
    5
    3
    1
         Physician determined not in patient’s interest
    -
    2
    -
         Physician determined not in the patient’s interest
    2
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Solid Tumor, pediatric
    Reporting group description
    		 Dasatinib was administered orally twice daily for 28 days (1 course of therapy). A course could be repeated every 28 days if the subject had stable disease and met pre-specified laboratory criteria. A course could be repeated 24 times, for a total of 24 courses. All subjects were started on 50 mg/m2/dose twice daily (BID). Doses were adjusted based on body surface area (BSA) determined at the beginning of each course. Dose level 1 had a dose of 50 mg/m2/dose BID, Dose level 2 had a dose of 65 mg/m2/dose BID, Dose level 3 had a dose of 85 mg/m2/dose BID, and Dose level 4 had a dose of 110 mg/m2/dose BID

    Reporting group title
    Leukemia, pediactric
    Reporting group description
    		 Dasatinib was administered orally twice daily for 28 days (1 course of therapy). A course could be repeated every 28 days if the subject had stable disease and met pre-specified laboratory criteria. A course could be repeated 24 times, for a total of 24 courses. All subjects were started on 50 mg/m2/dose twice daily (BID). Doses were adjusted based on body surface area (BSA) determined at the beginning of each course. Dose level 1 had a dose of 50 mg/m2/dose BID, Dose level 2 had a dose of 65 mg/m2/dose BID, Dose level 3 had a dose of 85 mg/m2/dose BID, and Dose level 4 had a dose of 110 mg/m2/dose BID

    Reporting group title
    Solid tumor, adult
    Reporting group description
    		 Dasatinib was administered orally twice daily for 28 days (1 course of therapy). A course could be repeated every 28 days if the subject had stable disease and met pre-specified laboratory criteria. A course could be repeated 24 times, for a total of 24 courses. All subjects were started on 50 mg/m2/dose twice daily (BID). Doses were adjusted based on body surface area (BSA) determined at the beginning of each course. Dose level 1 had a dose of 50 mg/m2/dose BID, Dose level 2 had a dose of 65 mg/m2/dose BID, Dose level 3 had a dose of 85 mg/m2/dose BID, and Dose level 4 had a dose of 110 mg/m2/dose BID

    Reporting group values
    		 Solid Tumor, pediatric Leukemia, pediactric Solid tumor, adult Total
    Number of subjects
    		 27 11 2 40
    Age categorical
    Units: Subjects
        2 - <11 years
    		 13 6 0 19
        11 - <18 years
    		 14 5 0 19
        >=18 years
    		 0 0 2 2
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 10.25 (2 to 17) 10.45 (2 to 17) 19 (18 to 20) -
    Gender categorical
    Units: Subjects
        Female
    		 14 4 1 19
        Male
    		 13 7 1 21
    Race
    Units: Subjects
        White
    		 19 7 2 28
        Black or African American
    		 5 1 0 6
        American Indian or Alaska Native
    		 0 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Asian Indian/Pakistani/Filipino
    		 2 0 0 2
        Other
    		 1 1 0 2
        Unknown
    		 0 2 0 2

    End points

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    End points reporting groups
    Reporting group title
    Solid Tumor, pediatric
    Reporting group description
    		 Dasatinib was administered orally twice daily for 28 days (1 course of therapy). A course could be repeated every 28 days if the subject had stable disease and met pre-specified laboratory criteria. A course could be repeated 24 times, for a total of 24 courses. All subjects were started on 50 mg/m2/dose twice daily (BID). Doses were adjusted based on body surface area (BSA) determined at the beginning of each course. Dose level 1 had a dose of 50 mg/m2/dose BID, Dose level 2 had a dose of 65 mg/m2/dose BID, Dose level 3 had a dose of 85 mg/m2/dose BID, and Dose level 4 had a dose of 110 mg/m2/dose BID

    Reporting group title
    Leukemia, pediactric
    Reporting group description
    		 Dasatinib was administered orally twice daily for 28 days (1 course of therapy). A course could be repeated every 28 days if the subject had stable disease and met pre-specified laboratory criteria. A course could be repeated 24 times, for a total of 24 courses. All subjects were started on 50 mg/m2/dose twice daily (BID). Doses were adjusted based on body surface area (BSA) determined at the beginning of each course. Dose level 1 had a dose of 50 mg/m2/dose BID, Dose level 2 had a dose of 65 mg/m2/dose BID, Dose level 3 had a dose of 85 mg/m2/dose BID, and Dose level 4 had a dose of 110 mg/m2/dose BID

    Reporting group title
    Solid tumor, adult
    Reporting group description
    		 Dasatinib was administered orally twice daily for 28 days (1 course of therapy). A course could be repeated every 28 days if the subject had stable disease and met pre-specified laboratory criteria. A course could be repeated 24 times, for a total of 24 courses. All subjects were started on 50 mg/m2/dose twice daily (BID). Doses were adjusted based on body surface area (BSA) determined at the beginning of each course. Dose level 1 had a dose of 50 mg/m2/dose BID, Dose level 2 had a dose of 65 mg/m2/dose BID, Dose level 3 had a dose of 85 mg/m2/dose BID, and Dose level 4 had a dose of 110 mg/m2/dose BID

    Primary: Number of Subjects With Death, Serious Adverse Events (SAEs), SAE Leading to Discontinuation, and Drug-Related Adverse Event (AE)

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    End point title
    		 Number of Subjects With Death, Serious Adverse Events (SAEs), SAE Leading to Discontinuation, and Drug-Related Adverse Event (AE) [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. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling.
    End point type
    Primary
    End point timeframe
    From the date of first dose of study medication to within 30 days post the last dose (approx. 3 years)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only summary statistics were planned for this endpoint
    End point values
    		 Solid Tumor, pediatric Leukemia, pediactric Solid tumor, adult
    Number of subjects analysed
    27
    11
    2
    Units: subjects
        SAE
    9
    4
    2
        SAE Leading to Discontinuation
    4
    2
    1
        Drug-Related AE
    24
    11
    1
        Deaths
    16
    1
    1
        Deaths Within 30 Days of End of Study
    3
    0
    1
    No statistical analyses for this end point

    Primary: Number of Subjects with At Least One Dose-Limiting Toxicity (DLT)

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    End point title
    		 Number of Subjects with At Least One Dose-Limiting Toxicity (DLT) [2]
    End point description
    Dose-limiting toxicity was defined as specific AEs that were considered by the investigator to be possibly, probably, or definitely attributable to dasatinib treatment. Population includes DLT Evaluable Subjects: all subjects who received dasatinib and either experienced a DLT at any time during treatment or received at least 85% of the prescribed dose per the protocol.
    End point type
    Primary
    End point timeframe
    From the date of first dose of study medication to within 30 days post the last dose (approx. 3 years)
    Notes
    [2] - 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 summary statistics were planned for this endpoint
    End point values
    		 Solid Tumor, pediatric Leukemia, pediactric Solid tumor, adult
    Number of subjects analysed
    17
    11
    1
    Units: subjects
    2
    3
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first dose of study drug until the last dose of study drug plus 30 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Solid Tumors (pediatric)
    Reporting group description
    		 Solid Tumors

    Reporting group title
    Leukemia
    Reporting group description
    		 Leukemia

    Reporting group title
    Solid Tumors (adult)
    Reporting group description
    		 Dasatinib was administered orally twice daily for 28 days (1 course of therapy). A course could be repeated every 28 days if the subject had stable disease and met pre-specified laboratory criteria. A course could be repeated 24 times, for a total of 24 courses. All subjects were started on 50 mg/m2/dose twice daily (BID). Doses were adjusted based on body surface area (BSA) determined at the beginning of each course. Dose level 1 had a dose of 50 mg/m2/dose BID, Dose level 2 had a dose of 65 mg/m2/dose BID, Dose level 3 had a dose of 85 mg/m2/dose BID, and Dose level 4 had a dose of 110 mg/m2/dose BID

    Serious adverse events
    		 Solid Tumors (pediatric) Leukemia Solid Tumors (adult)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 27 (33.33%)
    4 / 11 (36.36%)
    2 / 2 (100.00%)
         number of deaths (all causes)
    3
    0
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour pain
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 11 (0.00%)
    1 / 2 (50.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    4 / 27 (14.81%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    3 / 27 (11.11%)
    0 / 11 (0.00%)
    1 / 2 (50.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
    Disease progression
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 11 (0.00%)
    1 / 2 (50.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Hypoxia
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Apnoea
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 11 (0.00%)
    1 / 2 (50.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Photophobia
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Granulocyte count decreased
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neutrophil count decreased
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    White blood cell count decreased
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 11 (18.18%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 11 (18.18%)
    1 / 2 (50.00%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Exfoliative rash
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Sepsis
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypocalcaemia
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoalbuminaemia
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Solid Tumors (pediatric) Leukemia Solid Tumors (adult)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 27 (96.30%)
    11 / 11 (100.00%)
    2 / 2 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Haemangioma
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Flushing
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    0
    Hypotension
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    3
    1
    0
    Chills
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    0
    Disease progression
         subjects affected / exposed
    1 / 27 (3.70%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    Fatigue
         subjects affected / exposed
    11 / 27 (40.74%)
    4 / 11 (36.36%)
    0 / 2 (0.00%)
         occurrences all number
    12
    8
    0
    Gait disturbance
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    7 / 27 (25.93%)
    4 / 11 (36.36%)
    0 / 2 (0.00%)
         occurrences all number
    8
    5
    0
    Oedema
         subjects affected / exposed
    4 / 27 (14.81%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    5
    2
    0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Reproductive system and breast disorders
    Pelvic pain
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 27 (22.22%)
    2 / 11 (18.18%)
    0 / 2 (0.00%)
         occurrences all number
    7
    2
    0
    Bronchospasm
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    0
    Dyspnoea
         subjects affected / exposed
    4 / 27 (14.81%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    4
    0
    0
    Epistaxis
         subjects affected / exposed
    3 / 27 (11.11%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    0
    Hypoxia
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 11 (18.18%)
    0 / 2 (0.00%)
         occurrences all number
    1
    2
    0
    Pleural effusion
         subjects affected / exposed
    3 / 27 (11.11%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    4
    1
    0
    Respiratory alkalosis
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Rhinitis allergic
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    Wheezing
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    0
    Tachypnoea
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    2
    1
    0
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    2
    1
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    8 / 27 (29.63%)
    6 / 11 (54.55%)
    0 / 2 (0.00%)
         occurrences all number
    10
    9
    0
    Amylase increased
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    15 / 27 (55.56%)
    6 / 11 (54.55%)
    0 / 2 (0.00%)
         occurrences all number
    18
    13
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    3 / 27 (11.11%)
    2 / 11 (18.18%)
    0 / 2 (0.00%)
         occurrences all number
    3
    2
    0
    Blood bicarbonate decreased
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    3
    3
    0
    Blood bilirubin increased
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    Blood cholesterol increased
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    0
    Blood creatinine increased
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    Gamma-Glutamyltransferase increased
         subjects affected / exposed
    4 / 27 (14.81%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    4
    1
    0
    Granulocyte count decreased
         subjects affected / exposed
    9 / 27 (33.33%)
    5 / 11 (45.45%)
    0 / 2 (0.00%)
         occurrences all number
    10
    5
    0
    Haemoglobin decreased
         subjects affected / exposed
    11 / 27 (40.74%)
    8 / 11 (72.73%)
    0 / 2 (0.00%)
         occurrences all number
    19
    32
    0
    Liver palpable
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    International normalised ratio increased
         subjects affected / exposed
    4 / 27 (14.81%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    4
    1
    0
    Neutrophil count decreased
         subjects affected / exposed
    9 / 27 (33.33%)
    5 / 11 (45.45%)
    0 / 2 (0.00%)
         occurrences all number
    11
    7
    0
    Platelet count decreased
         subjects affected / exposed
    9 / 27 (33.33%)
    5 / 11 (45.45%)
    1 / 2 (50.00%)
         occurrences all number
    12
    8
    1
    Weight decreased
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    2
    1
    0
    Weight increased
         subjects affected / exposed
    0 / 27 (0.00%)
    3 / 11 (27.27%)
    0 / 2 (0.00%)
         occurrences all number
    0
    3
    0
    White blood cell count decreased
         subjects affected / exposed
    9 / 27 (33.33%)
    7 / 11 (63.64%)
    0 / 2 (0.00%)
         occurrences all number
    13
    11
    0
    Cardiac disorders
    Sinus bradycardia
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    0
    Sinus tachycardia
         subjects affected / exposed
    4 / 27 (14.81%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    4
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    7 / 27 (25.93%)
    2 / 11 (18.18%)
    0 / 2 (0.00%)
         occurrences all number
    8
    4
    0
    Neuropathy peripheral
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    0
    Tremor
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Blood and lymphatic system disorders
    Bone marrow failure
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Lymphopenia
         subjects affected / exposed
    7 / 27 (25.93%)
    3 / 11 (27.27%)
    0 / 2 (0.00%)
         occurrences all number
    12
    10
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    0
    Eye disorders
    Dry eye
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    2
    1
    0
    Abdominal pain
         subjects affected / exposed
    8 / 27 (29.63%)
    4 / 11 (36.36%)
    0 / 2 (0.00%)
         occurrences all number
    10
    7
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    Colitis
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    Constipation
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    2
    1
    0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    3
    0
    Diarrhoea
         subjects affected / exposed
    11 / 27 (40.74%)
    4 / 11 (36.36%)
    1 / 2 (50.00%)
         occurrences all number
    15
    7
    1
    Haematochezia
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Nausea
         subjects affected / exposed
    10 / 27 (37.04%)
    5 / 11 (45.45%)
    0 / 2 (0.00%)
         occurrences all number
    12
    7
    0
    Stomatitis
         subjects affected / exposed
    3 / 27 (11.11%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    3
    1
    0
    Vomiting
         subjects affected / exposed
    9 / 27 (33.33%)
    2 / 11 (18.18%)
    1 / 2 (50.00%)
         occurrences all number
    14
    4
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    2
    2
    0
    Dry skin
         subjects affected / exposed
    1 / 27 (3.70%)
    2 / 11 (18.18%)
    0 / 2 (0.00%)
         occurrences all number
    1
    3
    0
    Exfoliative rash
         subjects affected / exposed
    7 / 27 (25.93%)
    5 / 11 (45.45%)
    1 / 2 (50.00%)
         occurrences all number
    11
    8
    1
    Hair colour changes
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Petechiae
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    Photosensitivity reaction
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    4 / 27 (14.81%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    5
    0
    0
    Urinary bladder haemorrhage
         subjects affected / exposed
    3 / 27 (11.11%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    3
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 27 (14.81%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    7
    1
    0
    Back pain
         subjects affected / exposed
    4 / 27 (14.81%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    4
    1
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    0
    Neck pain
         subjects affected / exposed
    3 / 27 (11.11%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    0
    Pain in extremity
         subjects affected / exposed
    8 / 27 (29.63%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    10
    1
    0
    Infections and infestations
    Abdominal infection
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Bronchitis
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Candidiasis
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Catheter related infection
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Gingivitis
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    Influenza
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Lice infestation
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Otitis media
         subjects affected / exposed
    3 / 27 (11.11%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    3
    1
    0
    Pneumonia
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    0
    Rhinitis
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Sepsis
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Sinusitis
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    Urinary tract infection
         subjects affected / exposed
    2 / 27 (7.41%)
    0 / 11 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    3 / 27 (11.11%)
    3 / 11 (27.27%)
    0 / 2 (0.00%)
         occurrences all number
    3
    4
    0
    Dehydration
         subjects affected / exposed
    3 / 27 (11.11%)
    2 / 11 (18.18%)
    0 / 2 (0.00%)
         occurrences all number
    3
    2
    0
    Hyperglycaemia
         subjects affected / exposed
    8 / 27 (29.63%)
    5 / 11 (45.45%)
    1 / 2 (50.00%)
         occurrences all number
    14
    11
    1
    Hyperkalaemia
         subjects affected / exposed
    2 / 27 (7.41%)
    1 / 11 (9.09%)
    1 / 2 (50.00%)
         occurrences all number
    3
    4
    1
    Hypermagnesaemia
         subjects affected / exposed
    5 / 27 (18.52%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    7
    1
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    2
    1
    0
    Hypoalbuminaemia
         subjects affected / exposed
    9 / 27 (33.33%)
    4 / 11 (36.36%)
    1 / 2 (50.00%)
         occurrences all number
    10
    9
    1
    Hypocalcaemia
         subjects affected / exposed
    11 / 27 (40.74%)
    5 / 11 (45.45%)
    1 / 2 (50.00%)
         occurrences all number
    16
    6
    1
    Hypoglycaemia
         subjects affected / exposed
    1 / 27 (3.70%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    Hypokalaemia
         subjects affected / exposed
    8 / 27 (29.63%)
    5 / 11 (45.45%)
    0 / 2 (0.00%)
         occurrences all number
    8
    6
    0
    Hypomagnesaemia
         subjects affected / exposed
    3 / 27 (11.11%)
    3 / 11 (27.27%)
    0 / 2 (0.00%)
         occurrences all number
    6
    3
    0
    Hyponatraemia
         subjects affected / exposed
    11 / 27 (40.74%)
    1 / 11 (9.09%)
    1 / 2 (50.00%)
         occurrences all number
    14
    4
    1
    Hypophosphataemia
         subjects affected / exposed
    9 / 27 (33.33%)
    3 / 11 (27.27%)
    0 / 2 (0.00%)
         occurrences all number
    9
    7
    0
    Metabolic alkalosis
         subjects affected / exposed
    0 / 27 (0.00%)
    1 / 11 (9.09%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Jun 2006
    The purpose of this amendment was to update Section 11.4, “Dose escalation and determination of MTD in Ph+ leukemia subjects,” which was incorrectly revised during protocol development, and to include the most recent Comprehensive Adverse Event and Potential Risks (CAEPR) list (Version 2.0, dated 29-Mar-2006) for dasatinib.
    22 Oct 2006
    This amendment included various clarifications and administrative changes. The significant revisions were: • As solid tumor acquisition will not be pursued in this study, this secondary study aim was removed. • Timing guidelines for blood transfusions were added. • The renal function criteria were updated to use those developed by COG’s Developmental Therapeutics Committee. • The liver function eligibility criterion for ALT was changed from < 5xULN to < 110 U/L, and the ULN was established as 45 U/L. • Included PK sampling timepoints for subjects weighing < 10 kg. • The pharmacy section was updated to include the most recently COG Pharmacy Committee-approved monograph for Intrathecal Triple.

    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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