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    Clinical Trial Results:
    The TEAM trial (Tasigna efficacy in advanced melanoma): A phase II, open label, multi-center, single-arm study to assess the efficacy of Tasigna® in the treatment of patients with metastatic and/or inoperable melanoma harboring a c-Kit mutation Due to EudraCT system limitations, which EMA is aware of, results of crossover studies and data using 999 as data points are not accurately represented in this record. Please go to https://www.novctrd.com/CtrdWeb/home.nov for complete trial results

    Summary
    EudraCT number
    		 2009-015514-21
    Trial protocol
    		 BE   SE   DE   NL   IT   ES  
    Global end of trial date
    31 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jul 2018
    First version publication date
    06 Jul 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CAMN107B2301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01028222
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    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
    31 Dec 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 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 assess the clinical efficacy of nilotinib, based on overall response rate (ORR), in the treatment of c-Kit mutated melanoma in patients who have not received prior therapy with TKIs (tyrosine kinase inhibitors).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Jun 2010
    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
    Germany: 5
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    United States: 13
    Country: Number of subjects enrolled
    Australia: 1
    Country: Number of subjects enrolled
    China: 11
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Italy: 8
    Country: Number of subjects enrolled
    Sweden: 2
    Country: Number of subjects enrolled
    Switzerland: 3
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    Brazil: 5
    Worldwide total number of subjects
    55
    EEA total number of subjects
    20
    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)
    24
    From 65 to 84 years
    28
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The randomization ratio for the two treatment groups was 1:1.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nilotinib
    Arm description
    		 400 mg twice daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nilotininb
    Investigational medicinal product code
    AMN107
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Nilotinib was provided as 200 mg hard gelatin capsules for oral use.

    Arm title
    		 DTIC
    Arm description
    		 850 mg/m2 IV every 3 weeks
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Dacarbazine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    DTIC was supplied locally as sterile powder for i.v. infusion

    Number of subjects in period 1
    		Nilotinib DTIC
    Started
    42
    13
    Cross over from DTIC to Nilotinib
    0 [1]
    10
    Completed
    4
    0
    Not completed
    38
    13
         Consent withdrawn by subject
    1
    -
         Disease progression
    33
    9
         Adverse event, non-fatal
    2
    -
         Protocol deviation
    1
    -
         Crossover to nilotinib w/out progression
    -
    2
         Administrative problems
    1
    1
         Lost to follow-up
    -
    1
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of subjects in this period represents the number of patients who crossed over from DTIC to Nilotinib.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nilotinib
    Reporting group description
    		 400 mg twice daily

    Reporting group title
    DTIC
    Reporting group description
    		 850 mg/m2 IV every 3 weeks

    Reporting group values
    		 Nilotinib DTIC Total
    Number of subjects
    		 42 13 55
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 20 4 24
        From 65-84 years
    		 21 7 28
        85 years and over
    		 1 2 3
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    		 64.7 ( 12.39 ) 68.8 ( 12.99 ) -
    Gender, Male/Female
    Units: Participants
        Female
    		 23 8 31
        Male
    		 19 5 24

    End points

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    End points reporting groups
    Reporting group title
    Nilotinib
    Reporting group description
    		 400 mg twice daily

    Reporting group title
    DTIC
    Reporting group description
    		 850 mg/m2 IV every 3 weeks

    Primary: Overall response rate (ORR)

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    End point title
    		 Overall response rate (ORR) [1]
    End point description
    ORR was defined as the proportion of participants with a best overall response (BOR) of a confirmed complete response or partial response (CR+PR) determined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) based on local investigators' assessment (CT/MRI/photography). Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no unequivocal progression of non-TLs, and no new lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments at least 4 weeks apart.
    End point type
    Primary
    End point timeframe
    End of study (up to 39 months)
    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: As this was a single arm study, no statistical analysis was performed.
    End point values
    		 Nilotinib DTIC
    Number of subjects analysed
    42
    13
    Units: Participants
    11
    3
    No statistical analyses for this end point

    Secondary: Durable overall response rate (DORR)

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    End point title
    		 Durable overall response rate (DORR)
    End point description
    DORR was defined as the rate of best overall response (CR+PR) lasting at least 12 weeks determined by RECIST v1.0 based on local investigators' assessment (CT/MRI/photography). The duration of ORR responders is computed from the date of first documented response (CR/PR) to the date of first documented progression or death due to underlying disease. Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no worsening of non-TLs, and no new lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments at least 4 weeks apart.
    End point type
    Secondary
    End point timeframe
    End of study (up to 39 months)
    End point values
    		 Nilotinib DTIC
    Number of subjects analysed
    42
    13
    Units: Participants
    11
    3
    No statistical analyses for this end point

    Secondary: Progression free survival (PFS)

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    End point title
    		 Progression free survival (PFS)
    End point description
    PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined using RECIST v1.0, as a >=20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or unequivocal progression of non-target lesions.
    End point type
    Secondary
    End point timeframe
    End of study (up to 39 months)
    End point values
    		 Nilotinib DTIC
    Number of subjects analysed
    42
    13
    Units: Months
        median (confidence interval 95%)
    4.2 (2.1 to 5.8)
    4.2 (0.8 to 8)
    No statistical analyses for this end point

    Secondary: Overall survival (OS)

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    End point title
    		 Overall survival (OS)
    End point description
    OS was defined as the time from the date of the start of treatment to the date of death due to any cause.
    End point type
    Secondary
    End point timeframe
    End of study (up to 39 months)
    End point values
    		 Nilotinib DTIC
    Number of subjects analysed
    42
    13
    Units: Months
        median (confidence interval 95%)
    18 (10.9 to 20.3)
    22.8 (4.9 to 999)
    No statistical analyses for this end point

    Secondary: Time to objective response (TOR)

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    End point title
    		 Time to objective response (TOR)
    End point description
    TOR was defined as the time between the start date of treatment until first documented confirmed response of CR or PR determined by RECIST v1.0 based on local investigators' assessment (CT/MRI/photography). Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no unequivocal progression of non-TLs, and no new lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments at least 4 weeks apart.
    End point type
    Secondary
    End point timeframe
    End of study (up to 39 months)
    End point values
    		 Nilotinib DTIC
    Number of subjects analysed
    42
    13
    Units: months
        median (confidence interval 95%)
    999 (-999 to 999)
    999 (-999 to 999)
    No statistical analyses for this end point

    Secondary: Disease control rate (DCR)

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    End point title
    		 Disease control rate (DCR)
    End point description
    DCR was defined as the proportion of participants with an overall response of CR of any duration, PR of any duration, or stable disease (SD) for a minimum of 12 weeks from start of treatment. Per RECIST, CR: disappearance of all target lesions, all non-target lesions, and no new lesion; PR: a >=30% decrease in the sum of the longest dimensions of the target lesions (TLs) taking as a reference the baseline sum, no unequivocal progression of non-TLs, and no new lesions; PD, a >=20% increase in TLs, clearly worsening of non-TLs, or emergence of new lesions; SD: no change or small changes that do not meet previously given criteria for CR, PR or PD.
    End point type
    Secondary
    End point timeframe
    End of study (up to 39 months)
    End point values
    		 Nilotinib DTIC
    Number of subjects analysed
    42
    13
    Units: Participants
    20
    7
    No statistical analyses for this end point

    Secondary: PFS rate

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    End point title
    		 PFS rate
    End point description
    PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. Progression is defined using RECIST v1.0, as a >=20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or unequivocal progression of non-target lesions.
    End point type
    Secondary
    End point timeframe
    End of study (up to 39 months)
    End point values
    		 Nilotinib DTIC
    Number of subjects analysed
    42
    13
    Units: Percentage of participants
        number (not applicable)
    34.6
    23.1
    No statistical analyses for this end point

    Secondary: OS rate

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    End point title
    		 OS rate
    End point description
    OS was defined as the time from the date of the start of treatment to the date of death due to any cause.
    End point type
    Secondary
    End point timeframe
    End of study (up to 39 months)
    End point values
    		 Nilotinib DTIC
    Number of subjects analysed
    42
    13
    Units: Percentage of participants
        number (not applicable)
    63.6
    66.7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for AE
    Adverse event reporting additional description
    AE additional description
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Nilotinib
    Reporting group description
    		 Nilotinib

    Reporting group title
    Crossover nilotinib
    Reporting group description
    		 Crossover nilotinib

    Reporting group title
    DTIC
    Reporting group description
    		 DTIC

    Serious adverse events
    		 Nilotinib Crossover nilotinib DTIC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 42 (28.57%)
    4 / 10 (40.00%)
    1 / 13 (7.69%)
         number of deaths (all causes)
    1
    8
    0
         number of deaths resulting from adverse events
    0
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to central nervous system
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (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
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 10 (0.00%)
    0 / 13 (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
    Fatigue
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 10 (0.00%)
    0 / 13 (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 physical health deterioration
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 10 (0.00%)
    0 / 13 (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
    Oedema peripheral
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (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
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 10 (0.00%)
    0 / 13 (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
    Investigations
    Amylase increased
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 10 (0.00%)
    0 / 13 (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
    Blood creatinine increased
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 10 (0.00%)
    0 / 13 (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
    Lipase increased
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 10 (0.00%)
    0 / 13 (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
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 10 (0.00%)
    0 / 13 (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
    Joint dislocation
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 10 (0.00%)
    0 / 13 (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
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 10 (0.00%)
    0 / 13 (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
    Arrhythmia
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (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
    Myocardial infarction
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (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
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 10 (0.00%)
    0 / 13 (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
    Epilepsy
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (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
    Eye disorders
    Retinal detachment
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (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
    Visual impairment
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 10 (0.00%)
    0 / 13 (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
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 42 (4.76%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 10 (0.00%)
    0 / 13 (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
    Ascites
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (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
    Nausea
         subjects affected / exposed
    3 / 42 (7.14%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    3 / 5
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    3 / 42 (7.14%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 10 (0.00%)
    0 / 13 (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
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (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
    Infections and infestations
    Herpes zoster cutaneous disseminated
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (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
    Infection
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 10 (0.00%)
    0 / 13 (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
    Pneumonia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 10 (0.00%)
    0 / 13 (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
    Hyperglycaemia
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    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
    		 Nilotinib Crossover nilotinib DTIC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    40 / 42 (95.24%)
    10 / 10 (100.00%)
    9 / 13 (69.23%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Haemangioma
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Tumour pain
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 42 (7.14%)
    2 / 10 (20.00%)
    0 / 13 (0.00%)
         occurrences all number
    3
    2
    0
    Lymphoedema
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    1
    Vein disorder
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 42 (4.76%)
    3 / 10 (30.00%)
    1 / 13 (7.69%)
         occurrences all number
    2
    4
    4
    Chills
         subjects affected / exposed
    3 / 42 (7.14%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    3
    0
    0
    Fatigue
         subjects affected / exposed
    13 / 42 (30.95%)
    4 / 10 (40.00%)
    5 / 13 (38.46%)
         occurrences all number
    25
    6
    6
    Feeling cold
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    General physical health deterioration
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Oedema peripheral
         subjects affected / exposed
    3 / 42 (7.14%)
    2 / 10 (20.00%)
    1 / 13 (7.69%)
         occurrences all number
    3
    3
    1
    Pain
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    3 / 42 (7.14%)
    2 / 10 (20.00%)
    3 / 13 (23.08%)
         occurrences all number
    3
    3
    4
    Suprapubic pain
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    1
    0
    Temperature intolerance
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Ulcer haemorrhage
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 10 (10.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    9 / 42 (21.43%)
    3 / 10 (30.00%)
    2 / 13 (15.38%)
         occurrences all number
    13
    3
    3
    Dyspnoea
         subjects affected / exposed
    5 / 42 (11.90%)
    1 / 10 (10.00%)
    1 / 13 (7.69%)
         occurrences all number
    9
    1
    1
    Epistaxis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Lung infiltration
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Nasal congestion
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    1
    Throat irritation
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Wheezing
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    2
    0
    1
    Confusional state
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Depression
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Insomnia
         subjects affected / exposed
    5 / 42 (11.90%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    6
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    10 / 42 (23.81%)
    1 / 10 (10.00%)
    1 / 13 (7.69%)
         occurrences all number
    18
    1
    1
    Amylase increased
         subjects affected / exposed
    8 / 42 (19.05%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    10
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    8 / 42 (19.05%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    13
    0
    3
    Bilirubin conjugated increased
         subjects affected / exposed
    11 / 42 (26.19%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    27
    4
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    5 / 42 (11.90%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    5
    0
    0
    Blood bilirubin increased
         subjects affected / exposed
    19 / 42 (45.24%)
    3 / 10 (30.00%)
    1 / 13 (7.69%)
         occurrences all number
    45
    8
    1
    Blood bilirubin unconjugated increased
         subjects affected / exposed
    9 / 42 (21.43%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    26
    2
    0
    Blood cholesterol increased
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Blood creatinine increased
         subjects affected / exposed
    2 / 42 (4.76%)
    2 / 10 (20.00%)
    0 / 13 (0.00%)
         occurrences all number
    3
    3
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    4 / 42 (9.52%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    7
    2
    0
    Blood phosphorus decreased
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Blood pressure decreased
         subjects affected / exposed
    4 / 42 (9.52%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    4
    0
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    2
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    11 / 42 (26.19%)
    1 / 10 (10.00%)
    1 / 13 (7.69%)
         occurrences all number
    14
    3
    1
    Haemoglobin decreased
         subjects affected / exposed
    2 / 42 (4.76%)
    2 / 10 (20.00%)
    0 / 13 (0.00%)
         occurrences all number
    5
    6
    0
    Lipase increased
         subjects affected / exposed
    8 / 42 (19.05%)
    2 / 10 (20.00%)
    1 / 13 (7.69%)
         occurrences all number
    12
    2
    1
    Low density lipoprotein increased
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    2
    Platelet count decreased
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    2
    Total bile acids increased
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    4
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Wound
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Cardiac disorders
    Sinus bradycardia
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    1
    0
    Diabetic neuropathy
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Dizziness
         subjects affected / exposed
    3 / 42 (7.14%)
    2 / 10 (20.00%)
    2 / 13 (15.38%)
         occurrences all number
    3
    2
    2
    Epilepsy
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Headache
         subjects affected / exposed
    6 / 42 (14.29%)
    3 / 10 (30.00%)
    5 / 13 (38.46%)
         occurrences all number
    7
    3
    7
    Hypoaesthesia
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Monoplegia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Paraesthesia
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Speech disorder
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 42 (11.90%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    6
    0
    0
    Leukopenia
         subjects affected / exposed
    3 / 42 (7.14%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    8
    0
    0
    Lymphopenia
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    3
    2
    0
    Neutropenia
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    4
    0
    2
    Thrombocytopenia
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    3
    0
    1
    Ear and labyrinth disorders
    Otorrhoea
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Vertigo
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Eye disorders
    Eye pruritus
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    1
    0
    Lacrimation increased
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Vision blurred
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    1
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    3 / 42 (7.14%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    3
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    4 / 42 (9.52%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    4
    0
    0
    Constipation
         subjects affected / exposed
    9 / 42 (21.43%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    12
    0
    1
    Diarrhoea
         subjects affected / exposed
    7 / 42 (16.67%)
    3 / 10 (30.00%)
    1 / 13 (7.69%)
         occurrences all number
    9
    4
    1
    Dyspepsia
         subjects affected / exposed
    3 / 42 (7.14%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    4
    0
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Nausea
         subjects affected / exposed
    18 / 42 (42.86%)
    2 / 10 (20.00%)
    5 / 13 (38.46%)
         occurrences all number
    24
    2
    11
    Odynophagia
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 10 (10.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    1
    Oral discomfort
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Oral pain
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Tongue ulceration
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Toothache
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Vomiting
         subjects affected / exposed
    11 / 42 (26.19%)
    1 / 10 (10.00%)
    1 / 13 (7.69%)
         occurrences all number
    19
    1
    1
    Skin and subcutaneous tissue disorders
    Actinic keratosis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Alopecia
         subjects affected / exposed
    5 / 42 (11.90%)
    2 / 10 (20.00%)
    1 / 13 (7.69%)
         occurrences all number
    5
    4
    1
    Dry skin
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    1
    Erythema
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    1
    0
    Night sweats
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Photosensitivity reaction
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    2
    Pruritus
         subjects affected / exposed
    3 / 42 (7.14%)
    1 / 10 (10.00%)
    1 / 13 (7.69%)
         occurrences all number
    4
    1
    1
    Rash
         subjects affected / exposed
    20 / 42 (47.62%)
    3 / 10 (30.00%)
    2 / 13 (15.38%)
         occurrences all number
    24
    4
    2
    Skin burning sensation
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Skin exfoliation
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    1
    0
    Skin hypopigmentation
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Skin ulcer
         subjects affected / exposed
    0 / 42 (0.00%)
    2 / 10 (20.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    2
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 42 (9.52%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    9
    1
    0
    Back pain
         subjects affected / exposed
    2 / 42 (4.76%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    1
    0
    Bone pain
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    1
    0
    Muscle spasms
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 10 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    2
    Muscular weakness
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    1
    0
    Myalgia
         subjects affected / exposed
    2 / 42 (4.76%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    3
    0
    1
    Pain in extremity
         subjects affected / exposed
    5 / 42 (11.90%)
    2 / 10 (20.00%)
    2 / 13 (15.38%)
         occurrences all number
    7
    3
    2
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Ear infection
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Erysipelas
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Gastrointestinal infection
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    1
    Gingivitis
         subjects affected / exposed
    0 / 42 (0.00%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    Herpes zoster
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Influenza
         subjects affected / exposed
    2 / 42 (4.76%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    3
    2
    0
    Nasopharyngitis
         subjects affected / exposed
    3 / 42 (7.14%)
    2 / 10 (20.00%)
    2 / 13 (15.38%)
         occurrences all number
    3
    3
    3
    Oral fungal infection
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Oral herpes
         subjects affected / exposed
    1 / 42 (2.38%)
    0 / 10 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    1
    Pneumonia
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 10 (10.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    1
    Sinusitis
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    1
    0
    Staphylococcal infection
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Tooth infection
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 42 (2.38%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    1
    0
    Urinary tract infection
         subjects affected / exposed
    3 / 42 (7.14%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    3
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    13 / 42 (30.95%)
    3 / 10 (30.00%)
    2 / 13 (15.38%)
         occurrences all number
    15
    3
    2
    Dehydration
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Hypercholesterolaemia
         subjects affected / exposed
    4 / 42 (9.52%)
    1 / 10 (10.00%)
    1 / 13 (7.69%)
         occurrences all number
    7
    9
    2
    Hyperglycaemia
         subjects affected / exposed
    9 / 42 (21.43%)
    3 / 10 (30.00%)
    1 / 13 (7.69%)
         occurrences all number
    9
    9
    1
    Hyperkalaemia
         subjects affected / exposed
    3 / 42 (7.14%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    4
    0
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    2 / 42 (4.76%)
    2 / 10 (20.00%)
    1 / 13 (7.69%)
         occurrences all number
    5
    8
    2
    Hyperuricaemia
         subjects affected / exposed
    3 / 42 (7.14%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    5
    0
    0
    Hypocalcaemia
         subjects affected / exposed
    5 / 42 (11.90%)
    1 / 10 (10.00%)
    0 / 13 (0.00%)
         occurrences all number
    9
    1
    0
    Hypokalaemia
         subjects affected / exposed
    6 / 42 (14.29%)
    0 / 10 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    12
    0
    0
    Hypophosphataemia
         subjects affected / exposed
    0 / 42 (0.00%)
    1 / 10 (10.00%)
    0 / 13 (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 Aug 2010
    This amendment introduced the following key changes: To implement minor changes to the inclusion and exclusion criteria based on improved knowledge on the patient population and following input from the Steering Committee for the trial: •To clarify procedural and operational aspects of the protocol • To ensure greater consistency with the Imaging Charter developed and with the procedures of the Central Imaging Review committee working on the trial. Additionally, to ensure consistency between the protocol and Post Text Supplement 1 (RECIST 1.0) •As the population had been limited to patients receiving no more than one prior systemic anticancer therapy for advanced disease and to ensure balance between the two treatment arms (nilotinib and DTIC), randomization was stratified by whether or not the patient received prior systemic anticancer therapy for melanoma • To address other administrative and typographical corrections noted in the original protocol •To include updated safety information related to the use of nilotinib and the need to collect pregnancy information from partners of males taking nilotinib.
    27 Jul 2011
    This amendment introduced the following key changes: Due to substantial difficulties identifying and recruiting eligible patients, the trial design was altered from a randomized, two-arm, Phase III study to a single-arm, Simon two-stage Phase II study. While the original protocol required the recruitment of 120 patients, this amendment required the study to recruit only 41 patients (patients randomized to nilotinib prior to Amendment 2 were to be counted in this total, but those randomized to DTIC were not). There was scope within this amendment for patients randomized to DTIC under Amendment 1 or earlier to cross-over to nilotinib, either immediately or at the time of progression. Primary and secondary objectives and endpoints were updated. By implementing this amendment, the clinical study was to be concluded at an earlier date and important clinical information was thus to be disseminated to the medical community in a more rapid fashion.
    20 Dec 2012
    This amendment introduced the following key changes: The primary analysis was to be performed once all patients enrolled into the study had reached the Week 24 visit or had discontinued study treatment. This amendment was implemented to clarify: • The treatment of patients regardless if the primary endpoint was met or not • The extension of the follow-up to 24 months after last patient first visit to obtain longer term outcome data •The possibility for patients benefiting from the study treatment at the end of study in the opinion of the investigator to transition to a rollover study

    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.
    Due to EudraCT system limitations, which EMA is aware of, results of crossover studies and data using 999 as data points are not accurately represented in this record. Please go to https://www.novctrd.com/CtrdWeb/home.nov for complete trial results
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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