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    Clinical Trial Results:
    A phase 3, multi-center, open-label, randomized study of oral ABL001 versus bosutinib in patients with Chronic Myelogenous Leukemia in chronic phase (CML-CP), previously treated with 2 or more tyrosine kinase inhibitors

    Summary
    EudraCT number
    		 2016-002461-66
    Trial protocol
    		 HU   CZ   ES   BG   DE   GB   FR   NL   BE   IT   RO  
    Global end of trial date
    04 Dec 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Dec 2025
    First version publication date
    14 Dec 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CABL001A2301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03106779
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma, AG
    Sponsor organisation address
    Lichtstrasse 35, Basel, Switzerland, 4056
    Public contact
    Clinical Disclosure Office, Novartis Pharma, AG, 41 613241111, novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma, AG, 41 613241111, novartis.email@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    04 Dec 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Dec 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the MMR rate at 24 weeks of asciminib versus bosutinib Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com for complete trial results.
    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
    26 Oct 2017
    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
    Argentina: 7
    Country: Number of subjects enrolled
    Australia: 7
    Country: Number of subjects enrolled
    Brazil: 19
    Country: Number of subjects enrolled
    Bulgaria: 3
    Country: Number of subjects enrolled
    Canada: 5
    Country: Number of subjects enrolled
    Czechia: 2
    Country: Number of subjects enrolled
    France: 17
    Country: Number of subjects enrolled
    Germany: 18
    Country: Number of subjects enrolled
    Hungary: 3
    Country: Number of subjects enrolled
    Israel: 2
    Country: Number of subjects enrolled
    Italy: 7
    Country: Number of subjects enrolled
    Japan: 16
    Country: Number of subjects enrolled
    Korea, Republic of: 11
    Country: Number of subjects enrolled
    Lebanon: 3
    Country: Number of subjects enrolled
    Mexico: 1
    Country: Number of subjects enrolled
    Netherlands: 7
    Country: Number of subjects enrolled
    Romania: 4
    Country: Number of subjects enrolled
    Russian Federation: 33
    Country: Number of subjects enrolled
    Saudi Arabia: 5
    Country: Number of subjects enrolled
    Serbia: 3
    Country: Number of subjects enrolled
    Spain: 11
    Country: Number of subjects enrolled
    Switzerland: 2
    Country: Number of subjects enrolled
    Türkiye: 10
    Country: Number of subjects enrolled
    United Kingdom: 15
    Country: Number of subjects enrolled
    United States: 22
    Worldwide total number of subjects
    233
    EEA total number of subjects
    72
    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)
    189
    From 65 to 84 years
    44
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were treated at a total of 84 sites.

    Pre-assignment
    Screening details
    		 Randomization was stratified by major cytogenetic response (MCyR) at screening.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Asciminib
    Arm description
    		 Participants randomized to asciminib 40mg BID
    Arm type
    		 Experimental

    Investigational medicinal product name
    Asciminib
    Investigational medicinal product code
    ABL001
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Asciminib 40 mg (20 mg and 40 mg dose strength tablets) was taken orally with a twice daily (BID) fasted.

    Arm title
    		 Bosutinib
    Arm description
    		 Participants randomized to bosutinib 500mg QD
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Bosotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Bosutinib 500 mg (100 mg and 500 mg dose strength tablets) was taken once daily (QD) fed dosing.

    Number of subjects in period 1
    		Asciminib Bosutinib
    Started
    157
    76
    Treated
    156
    76
    Not Treated
    1 [1]
    0 [2]
    Switched to receive asciminib
    0 [3]
    25
    Completed
    77
    8
    Not completed
    80
    68
         Adverse event, serious fatal
    4
    -
         Physician decision
    13
    7
         Adverse event, non-fatal
    11
    21
         Progressive Disease
    2
    3
         Pregnancy
    1
    -
         Subject/Guardian Decision
    6
    7
         Lost to follow-up
    1
    2
         Lack of efficacy
    40
    28
         Protocol deviation
    1
    -
         Not treated
    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: Added just for clarification
    [2] - 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: Added just for clarification
    [3] - 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: Added just for clarification

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Asciminib
    Reporting group description
    		 Participants randomized to asciminib 40mg BID

    Reporting group title
    Bosutinib
    Reporting group description
    		 Participants randomized to bosutinib 500mg QD

    Reporting group values
    		 Asciminib Bosutinib Total
    Number of subjects
    		 157 76 233
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 128 61 189
        From 65-84 years
    		 29 15 44
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.0 ( 13.49 ) 51.0 ( 13.95 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 75 45 120
        Male
    		 82 31 113
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 118 56 174
        Asian
    		 22 11 33
        Black or African American
    		 8 2 10
        American Indian or Alaska Native
    		 1 0 1
        Other
    		 5 7 12
        Unknown
    		 3 0 3

    End points

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    End points reporting groups
    Reporting group title
    Asciminib
    Reporting group description
    		 Participants randomized to asciminib 40mg BID

    Reporting group title
    Bosutinib
    Reporting group description
    		 Participants randomized to bosutinib 500mg QD

    Primary: Major Molecular Response (MMR) rate at 24 weeks

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    End point title
    		 Major Molecular Response (MMR) rate at 24 weeks
    End point description
    MMR was defined as a ≥ 3.0 log reduction in BCR-ABL1 transcripts compared to the standardized baseline equivalent to ≤ 0.1% BCR-ABL1/ABL% by international scale (IS) as measured by RQ-PCR.
    End point type
    Primary
    End point timeframe
    24 weeks
    End point values
    		 Asciminib Bosutinib
    Number of subjects analysed
    157
    76
    Units: Percentage of participants
        number (not applicable)
    25.48
    13.16
    Statistical analysis title
    		 Analysis for MMR at 24 weeks
    Comparison groups
    Asciminib v Bosutinib
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.029
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 treatment difference in the MMR rate
    Point estimate
    12.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.19
         upper limit
    		 22.3

    Secondary: Major Molecular Response (MMR) rate at 96 weeks (Key secondary endpoint)

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    End point title
    		 Major Molecular Response (MMR) rate at 96 weeks (Key secondary endpoint)
    End point description
    MMR at 96 weeks was defined as the percentage of participants with MMR at 96 weeks. MMR was defined as a ≥ 3.0 log reduction in BCR-ABL1 transcripts compared to the standardized baseline equivalent to ≤ 0.1% BCR-ABL1/ABL% by international scale (IS) as measured by RQ-PCR.
    End point type
    Secondary
    End point timeframe
    96 Weeks
    End point values
    		 Asciminib Bosutinib
    Number of subjects analysed
    157
    76
    Units: Percentage of participants
        number (not applicable)
    35.78
    15.79
    Statistical analysis title
    		 MMR at 96 weeks
    Comparison groups
    Asciminib v Bosutinib
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Cochran-Mantel- Haenszel chi-square test
    Point estimate
    21.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 10.53
         upper limit
    		 32.95

    Secondary: Complete Cytogenetic Response (CCyR) rate at scheduled time points

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    End point title
    		 Complete Cytogenetic Response (CCyR) rate at scheduled time points
    End point description
    Cytogenic response included Complete, Partial, Major, Minor, Minimal and no response. Cytogenetic response was assessed as the percentage of Ph+ metaphases in the bone marrow and is defined as the following: Complete (CCyR) - 0% Ph+ metaphases; Partial (PCyR) - >0 to 35% Ph+ metaphases; Major (MCyR) - 0 to 35% Ph+ metaphases; Minor (mCyR) - >35 to 65% Ph+ metaphases; Minimal - >65 to 95% Ph+ metaphases; None - >95 to 100% Ph+ metaphases.
    End point type
    Secondary
    End point timeframe
    at 24, 48, 72, 96, 120 and 144 weeks
    End point values
    		 Asciminib Bosutinib
    Number of subjects analysed
    103
    62
    Units: Participants
        at Week 24
    42
    15
        at Week 48
    41
    13
        at Week 72
    39
    12
        at Week 96
    41
    10
        at Week 120
    37
    7
        at Week 144
    35
    4
    No statistical analyses for this end point

    Secondary: Complete Cytogenetic Response rate by scheduled time points

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    End point title
    		 Complete Cytogenetic Response rate by scheduled time points
    End point description
    Cytogenic response included Complete, Partial, Major, Minor, Minimal and no response. Cytogenetic response was assessed as the percentage of Ph+ metaphases in the bone marrow and is defined as the following: Complete (CCyR) - 0% Ph+ metaphases; Partial (PCyR) - >0 to 35% Ph+ metaphases; Major (MCyR) - 0 to 35% Ph+ metaphases; Minor (mCyR) - >35 to 65% Ph+ metaphases; Minimal - >65 to 95% Ph+ metaphases; None - >95 to 100% Ph+ metaphases.
    End point type
    Secondary
    End point timeframe
    by 24, 48, 72, 96, 120 and 144 weeks
    End point values
    		 Asciminib Bosutinib
    Number of subjects analysed
    103
    62
    Units: Participants
        by Week 24
    42
    15
        by Week 48
    47
    22
        by Week 72
    49
    22
        by Week 96
    51
    22
        by Week 120
    51
    22
        by Week 144
    51
    22
    No statistical analyses for this end point

    Secondary: Major Molecular Response (MMR) rate at all scheduled data collection time points except Weeks 24 & 96

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    End point title
    		 Major Molecular Response (MMR) rate at all scheduled data collection time points except Weeks 24 & 96
    End point description
    MMR was defined as a ≥ 3.0 log reduction in BCR-ABL1 transcripts compared to the standardized baseline equivalent to ≤ 0.1% BCR-ABL1/ABL% by international scale (IS) as measured by RQ-PCR.
    End point type
    Secondary
    End point timeframe
    at Weeks 36, 48, 60, 72, 84, 108, 120, 132, 144 & 156
    End point values
    		 Asciminib Bosutinib
    Number of subjects analysed
    157
    76
    Units: Participants
        at Week 36
    41
    9
        at Week 48
    46
    10
        at Week 60
    52
    11
        at Week 72
    52
    12
        at Week 84
    50
    10
        at Week 108
    53
    11
        at Week 120
    57
    8
        at Week 132
    58
    8
        at Week 144
    59
    7
        at Week 156
    53
    8
    No statistical analyses for this end point

    Secondary: Major Molecular Response (MMR) rate by all scheduled data collection time points

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    End point title
    		 Major Molecular Response (MMR) rate by all scheduled data collection time points
    End point description
    MMR was defined as a ≥ 3.0 log reduction in BCR-ABL1 transcripts compared to the standardized baseline equivalent to ≤ 0.1% BCR-ABL1/ABL% by international scale (IS) as measured by RQ-PCR. Overall time point has the count indicating participants achieving MMR at any time during the study.
    End point type
    Secondary
    End point timeframe
    by Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 & 156, Overall
    End point values
    		 Asciminib Bosutinib
    Number of subjects analysed
    157
    76
    Units: Participants
        by Week 4
    3
    0
        by Week 8
    12
    4
        by Week 12
    30
    7
        by Week 16
    39
    8
        by Week 24
    43
    11
        by Week 36
    51
    13
        by Week 48
    55
    15
        by Week 60
    60
    16
        by Week 72
    60
    17
        by Week 84
    63
    17
        by Week 96
    67
    18
        by Week 108
    67
    18
        by Week 120
    68
    18
        by Week 132
    70
    18
        by Week 144
    71
    18
        by Week 156
    71
    18
        Overall
    74
    19
    No statistical analyses for this end point

    Secondary: Time to Major Molecular Response (MMR)

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    End point title
    		 Time to Major Molecular Response (MMR)
    End point description
    Time to MMR was defined as the time from the date of randomization to the date of the first documented MMR.
    End point type
    Secondary
    End point timeframe
    216 Weeks
    End point values
    		 Asciminib Bosutinib
    Number of subjects analysed
    74
    19
    Units: Weeks
        median (full range (min-max))
    16.3 (4 to 216)
    24.1 (7 to 216)
    No statistical analyses for this end point

    Secondary: Duration of Major Molecular Response (MMR)

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    End point title
    		 Duration of Major Molecular Response (MMR)
    End point description
    Duration of MMR was defined as the time from the date of first documented MMR to the earliest date of loss of MMR, progression to Accelerated phase (AP) or Blast crisis (BC), or Chronic myeloid leukemia (CML)-related death.
    End point type
    Secondary
    End point timeframe
    216 Weeks
    End point values
    		 Asciminib Bosutinib
    Number of subjects analysed
    74
    19
    Units: Weeks
        median (full range (min-max))
    999 (999 to 999)
    999 (999 to 999)
    No statistical analyses for this end point

    Secondary: Time to Complete Cytogenetic Response Rate (CCyR) among participants who achieved CCyR

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    End point title
    		 Time to Complete Cytogenetic Response Rate (CCyR) among participants who achieved CCyR
    End point description
    Time to CCyR was defined as the time from the date of randomization to the date of the first documented CCyR.
    End point type
    Secondary
    End point timeframe
    216 Weeks
    End point values
    		 Asciminib Bosutinib
    Number of subjects analysed
    52
    22
    Units: Weeks
        median (full range (min-max))
    24.3 (23 to 216)
    24.3 (12 to 53)
    No statistical analyses for this end point

    Secondary: Duration of Complete Cytogenetic Response (CCyR)

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    End point title
    		 Duration of Complete Cytogenetic Response (CCyR)
    End point description
    Duration of CCyR was defined as the time between date of first documented CCyR and the earliest date of loss of CCyR, progression to AP/BC, or CML-related death for participants in the Cytogenetic Responder Set. The time was censored at the last cytogenetic assessment date on treatment for participants for whom none of the events was reported or last PCR evaluation on treatment indicating MMR.
    End point type
    Secondary
    End point timeframe
    144 weeks
    End point values
    		 Asciminib Bosutinib
    Number of subjects analysed
    52
    22
    Units: Weeks
        median (full range (min-max))
    999 (999 to 999)
    99 (64.1 to 999)
    No statistical analyses for this end point

    Secondary: Time to treatment failure (TTF)

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    End point title
    		 Time to treatment failure (TTF)
    End point description
    TTF was defined as the time from date of randomization to an event of treatment failure. Treatment failure was defined as meeting a lack of efficacy criterion or discontinuing treatment due to any reason.
    End point type
    Secondary
    End point timeframe
    156 Weeks
    End point values
    		 Asciminib Bosutinib
    Number of subjects analysed
    157
    76
    Units: Year
        median (confidence interval 95%)
    2.4 (1.0 to 999)
    0.5 (0.5 to 0.6)
    No statistical analyses for this end point

    Secondary: Progression free survival per Kaplan-Meier event free estimates

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    End point title
    		 Progression free survival per Kaplan-Meier event free estimates
    End point description
    Progression-free survival was defined as the time from the date of randomization to the earliest occurrence of documented disease progression to AP/BC or the date of death from any cause (including progressions and deaths observed during the survival follow-up period), per Kaplan-Meier.
    End point type
    Secondary
    End point timeframe
    5 years after the last patient enrolled into the study receives the first dose of the randomized treatment
    End point values
    		 Asciminib Bosutinib
    Number of subjects analysed
    157
    76
    Units: Years
        median (confidence interval 95%)
    5.6 (4.6 to 999)
    5.0 (3.6 to 999)
    No statistical analyses for this end point

    Secondary: Overall survival (OS)

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    End point title
    		 Overall survival (OS)
    End point description
    Overall survival is defined as the time from the date of randomization to the date of death (including the survival follow-up period) per Kaplan-Meier (KM).
    End point type
    Secondary
    End point timeframe
    5 years after the last patient enrolled into the study receives the first dose of the randomized treatment
    End point values
    		 Asciminib Bosutinib
    Number of subjects analysed
    157
    76
    Units: Years
        median (confidence interval 95%)
    999 (999 to 999)
    99 (6.3 to 999)
    No statistical analyses for this end point

    Secondary: Trough plasma concentrations for asciminib

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    End point title
    		 Trough plasma concentrations for asciminib [1]
    End point description
    Measured concentration at the end of a dosing interval at steady state (taken directly before next administration)
    End point type
    Secondary
    End point timeframe
    Week 2 Day 1 at: 0hr (pre-dose), 0.5hr, 1hr, 2hr, 3hr, 4hr, 6hr, 8hr & 12hr post-dose
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Analysis for this endpoint was not planned
    End point values
    		 Asciminib
    Number of subjects analysed
    14
    Units: ng/mL
        median (full range (min-max))
    238 (145 to 551)
    No statistical analyses for this end point

    Secondary: PK parameter: Cmax for asciminib

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    End point title
    		 PK parameter: Cmax for asciminib [2]
    End point description
    Maximum (peak) observed plasma concentration after dose administration (mass x volume-1).
    End point type
    Secondary
    End point timeframe
    Week 2 Day 1 at pre-dose, 0.5hr, 1hr, 2hr, 3hr, 4hr, 6hr, 8hr & 12hr post-dose
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Analysis for this endpoint was not planned
    End point values
    		 Asciminib
    Number of subjects analysed
    15
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    971 ( 48.3 )
    No statistical analyses for this end point

    Secondary: PK parameter: Tmax for asciminib

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    End point title
    		 PK parameter: Tmax for asciminib [3]
    End point description
    Time to reach maximum (peak) plasma concentration after dose administration (time). Actual sampling times were taken into consideration for the pharmacokinetic analysis.
    End point type
    Secondary
    End point timeframe
    Week 2 Day 1 at: 0hr (pre-dose), 0.5hr, 1hr, 2hr, 3hr, 4hr, 6hr, 8hr & 12hr post-dose
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Analysis for this endpoint was not planned
    End point values
    		 Asciminib
    Number of subjects analysed
    15
    Units: hour (hr)
        median (full range (min-max))
    1.92 (0.983 to 3.33)
    No statistical analyses for this end point

    Secondary: PK parameter: AUC0-12h for asciminib

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    End point title
    		 PK parameter: AUC0-12h for asciminib [4]
    End point description
    Area under the plasma concentration-time curve from time zero to 12 hours (mass x time x volume-1)
    End point type
    Secondary
    End point timeframe
    Week 2 Day 1 at: 0hr (pre-dose), 0.5hr, 1hr, 2hr, 3hr, 4hr, 6hr, 8hr & 12hr post-dose
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Analysis for this endpoint was not planned
    End point values
    		 Asciminib
    Number of subjects analysed
    14
    Units: ng*hr/mL
        geometric mean (geometric coefficient of variation)
    5810 ( 32.9 )
    No statistical analyses for this end point

    Secondary: PK parameter: CL/F for asciminib

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    End point title
    		 PK parameter: CL/F for asciminib [5]
    End point description
    Total apparent body clearance of drug from the plasma after oral administration (volume x time-1).
    End point type
    Secondary
    End point timeframe
    Week 2 day 1 at: 0hr (pre-dose), 0.5hr, 1hr, 2hr, 3hr, 4hr, 6hr, 8hr & 12hr post-dose
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Analysis for this endpoint was not planned
    End point values
    		 Asciminib
    Number of subjects analysed
    14
    Units: L/hr
        median (full range (min-max))
    7.29 (3.73 to 11.5)
    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
    26.0
    Reporting groups
    Reporting group title
    Bosutinib
    Reporting group description
    		 Bosutinib

    Reporting group title
    Asciminib
    Reporting group description
    		 Asciminib

    Serious adverse events
    		 Bosutinib Asciminib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    21 / 76 (27.63%)
    34 / 156 (21.79%)
         number of deaths (all causes)
    1
    5
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myeloid leukaemia
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal metastasis
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal neoplasm
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic occlusion
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Complication associated with device
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Pyrexia
         subjects affected / exposed
    1 / 76 (1.32%)
    2 / 156 (1.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired healing
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthermia
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    3 / 76 (3.95%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device malfunction
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Ejection fraction decreased
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    1 / 76 (1.32%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 76 (1.32%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorder
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 76 (0.00%)
    3 / 156 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac failure congestive
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral disorder
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Central nervous system vasculitis
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-traumatic headache
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Toxic optic neuropathy
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 76 (1.32%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenitis
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric arterial occlusion
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric artery thrombosis
         subjects affected / exposed
    1 / 76 (1.32%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Mesenteric artery embolism
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 76 (1.32%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug eruption
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    2 / 76 (2.63%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    7 / 7
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelocaliectasis
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Flank pain
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle spasms
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Peritonitis
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mycobacterium avium complex infection
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 76 (0.00%)
    3 / 156 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 76 (0.00%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 156 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 76 (1.32%)
    1 / 156 (0.64%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Bosutinib Asciminib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    72 / 76 (94.74%)
    130 / 156 (83.33%)
    Investigations
    Amylase increased
         subjects affected / exposed
    4 / 76 (5.26%)
    9 / 156 (5.77%)
         occurrences all number
    4
    14
    Alanine aminotransferase increased
         subjects affected / exposed
    23 / 76 (30.26%)
    8 / 156 (5.13%)
         occurrences all number
    32
    9
    Aspartate aminotransferase increased
         subjects affected / exposed
    16 / 76 (21.05%)
    9 / 156 (5.77%)
         occurrences all number
    22
    9
    Neutrophil count decreased
         subjects affected / exposed
    4 / 76 (5.26%)
    8 / 156 (5.13%)
         occurrences all number
    7
    14
    Lipase increased
         subjects affected / exposed
    5 / 76 (6.58%)
    8 / 156 (5.13%)
         occurrences all number
    7
    18
    Blood creatinine increased
         subjects affected / exposed
    6 / 76 (7.89%)
    6 / 156 (3.85%)
         occurrences all number
    7
    7
    Platelet count decreased
         subjects affected / exposed
    5 / 76 (6.58%)
    11 / 156 (7.05%)
         occurrences all number
    10
    17
    Vascular disorders
    Hypertension
         subjects affected / exposed
    4 / 76 (5.26%)
    23 / 156 (14.74%)
         occurrences all number
    4
    25
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 76 (3.95%)
    14 / 156 (8.97%)
         occurrences all number
    3
    16
    Headache
         subjects affected / exposed
    16 / 76 (21.05%)
    31 / 156 (19.87%)
         occurrences all number
    19
    37
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    6 / 76 (7.89%)
    16 / 156 (10.26%)
         occurrences all number
    7
    16
    Thrombocytopenia
         subjects affected / exposed
    14 / 76 (18.42%)
    36 / 156 (23.08%)
         occurrences all number
    42
    56
    Neutropenia
         subjects affected / exposed
    17 / 76 (22.37%)
    30 / 156 (19.23%)
         occurrences all number
    61
    66
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    4 / 76 (5.26%)
    3 / 156 (1.92%)
         occurrences all number
    4
    4
    Fatigue
         subjects affected / exposed
    8 / 76 (10.53%)
    24 / 156 (15.38%)
         occurrences all number
    9
    28
    Asthenia
         subjects affected / exposed
    1 / 76 (1.32%)
    14 / 156 (8.97%)
         occurrences all number
    1
    20
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 76 (1.32%)
    9 / 156 (5.77%)
         occurrences all number
    1
    13
    Oedema peripheral
         subjects affected / exposed
    3 / 76 (3.95%)
    12 / 156 (7.69%)
         occurrences all number
    3
    15
    Pyrexia
         subjects affected / exposed
    7 / 76 (9.21%)
    5 / 156 (3.21%)
         occurrences all number
    12
    5
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    13 / 76 (17.11%)
    14 / 156 (8.97%)
         occurrences all number
    14
    15
    Abdominal pain upper
         subjects affected / exposed
    5 / 76 (6.58%)
    7 / 156 (4.49%)
         occurrences all number
    6
    8
    Constipation
         subjects affected / exposed
    4 / 76 (5.26%)
    8 / 156 (5.13%)
         occurrences all number
    4
    11
    Diarrhoea
         subjects affected / exposed
    55 / 76 (72.37%)
    20 / 156 (12.82%)
         occurrences all number
    84
    21
    Dyspepsia
         subjects affected / exposed
    3 / 76 (3.95%)
    11 / 156 (7.05%)
         occurrences all number
    3
    12
    Nausea
         subjects affected / exposed
    36 / 76 (47.37%)
    18 / 156 (11.54%)
         occurrences all number
    45
    24
    Vomiting
         subjects affected / exposed
    20 / 76 (26.32%)
    12 / 156 (7.69%)
         occurrences all number
    28
    18
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    2 / 76 (2.63%)
    8 / 156 (5.13%)
         occurrences all number
    2
    8
    Dyspnoea
         subjects affected / exposed
    5 / 76 (6.58%)
    8 / 156 (5.13%)
         occurrences all number
    5
    8
    Cough
         subjects affected / exposed
    6 / 76 (7.89%)
    14 / 156 (8.97%)
         occurrences all number
    6
    18
    Pleural effusion
         subjects affected / exposed
    4 / 76 (5.26%)
    2 / 156 (1.28%)
         occurrences all number
    8
    2
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    5 / 76 (6.58%)
    8 / 156 (5.13%)
         occurrences all number
    8
    9
    Rash
         subjects affected / exposed
    18 / 76 (23.68%)
    16 / 156 (10.26%)
         occurrences all number
    35
    17
    Rash maculo-papular
         subjects affected / exposed
    3 / 76 (3.95%)
    8 / 156 (5.13%)
         occurrences all number
    3
    8
    Dry skin
         subjects affected / exposed
    6 / 76 (7.89%)
    8 / 156 (5.13%)
         occurrences all number
    6
    8
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 76 (1.32%)
    11 / 156 (7.05%)
         occurrences all number
    1
    12
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 76 (2.63%)
    24 / 156 (15.38%)
         occurrences all number
    2
    35
    Back pain
         subjects affected / exposed
    4 / 76 (5.26%)
    12 / 156 (7.69%)
         occurrences all number
    4
    14
    Muscle spasms
         subjects affected / exposed
    1 / 76 (1.32%)
    8 / 156 (5.13%)
         occurrences all number
    2
    8
    Pain in extremity
         subjects affected / exposed
    5 / 76 (6.58%)
    15 / 156 (9.62%)
         occurrences all number
    6
    18
    Myalgia
         subjects affected / exposed
    6 / 76 (7.89%)
    10 / 156 (6.41%)
         occurrences all number
    6
    14
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    3 / 76 (3.95%)
    18 / 156 (11.54%)
         occurrences all number
    3
    21
    COVID-19
         subjects affected / exposed
    5 / 76 (6.58%)
    17 / 156 (10.90%)
         occurrences all number
    5
    17
    Bronchitis
         subjects affected / exposed
    4 / 76 (5.26%)
    2 / 156 (1.28%)
         occurrences all number
    5
    2
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 76 (6.58%)
    13 / 156 (8.33%)
         occurrences all number
    8
    16
    Metabolism and nutrition disorders
    Hypophosphataemia
         subjects affected / exposed
    5 / 76 (6.58%)
    2 / 156 (1.28%)
         occurrences all number
    6
    2
    Decreased appetite
         subjects affected / exposed
    6 / 76 (7.89%)
    8 / 156 (5.13%)
         occurrences all number
    6
    11

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Apr 2017
    The purpose of this amendment was to identify the exclusionary mutation correctly, as “V299L” in the protocol, which was inadvertently identified as “V229L” throughout the protocol. In addition, some inconsistencies were corrected.
    13 Jul 2018
    The frequency of bone marrow aspirate (BMA) to perform cytogenetic analysis was decreased in accordance with treatment guidelines European LeukemiaNet (ELN) Guidelines and National Comprehensive Cancer Network (NCCN) guidelines. Initially BMAs were foreseen at screening, every 24 weeks thereafter and at EOT. With the protocol amendment BMA was no longer needed for participants that had achieved major molecular response (MMR) during study, however bone marrow aspirate (BMA) assessment was requested at end of treatment (EOT) for biomarker analysis. Based on the identification of pancreas as potential target tissues in the toxicity studies performed in rats, dogs and cynomolgus monkeys, the screening threshold for lipase was increased from ≤ ULN to ≤ 1.5 x ULN (CTCAE v4.03 grade 1). The requirement of amylase screening was removed, because amylase was not considered as a specific marker for pancreatitis, as up to 60% of total serum amylase originates from non-pancreatic sources.
    14 Dec 2018
    For inclusion in the study, the threshold of ≥ 1% BCR::ABL1 was reduced to BCR::ABL1 ratio >0.1% IS for participants with intolerance to most recent TKI treatment. With this amendment, participants who had failed bosutinib were offered the possibility to continue in the study by receiving asciminib, if investigators considered that this treatment option was in the best interest of the participant.
    05 Aug 2020
    Based on FDA request, requirement for male contraception was reintroduced in the 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, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com 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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