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← Chronic Myeloid Leukemia

NCT00261846 · STUDY IN CONTEXT

Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).

Safety population included all participants who received at least 1 dose of study medication.

→

primary · POSTED

MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT. DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1). NA = not estimable.

Safety population included all participants who received at least 1 dose of study medication

→

primary · POSTED

Maximum Observed Plasma Concentration (Cmax) - Part 1

Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment.

→

primary · POSTED

Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1

Evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline efficacy assessment.

→

primary · POSTED

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. NA = not estimable.

Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.

→

primary · POSTED

AUC(0-48)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-48).

Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-chronic-myeloid-leukemia
nct id
NCT00261846
trial label
Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
9
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00261846
    outcome key
    om-0000
    source section id
    NCT00261846-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With Dose Limiting Toxicity (DLT)
    endpoint definition
    DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1).
    time origin
    Part 1 Baseline up to Day 28
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Safety population included all participants who received at least 1 dose of study medication.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00261846
    outcome key
    om-0001
    source section id
    NCT00261846-om-0001
    source outcome index
    1
    endpoint
    Maximum Tolerated Dose (MTD)
    endpoint definition
    MTD was defined as highest dose level for which no more than 1 participant in a dose cohort experienced DLT. DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity, any clinically-significant grade 2 non-hematologic toxicity that requires 14 days to resolve (to grade 1). NA = not estimable.
    time origin
    Part 1 Baseline up to Day 28
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Safety population included all participants who received at least 1 dose of study medication
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00261846
    outcome key
    om-0002
    source section id
    NCT00261846-om-0002
    source outcome index
    2
    endpoint
    Maximum Observed Plasma Concentration (Cmax) - Part 1
    endpoint definition
    Maximum Observed Plasma Concentration (Cmax) - Part 1
    time origin
    0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00261846
    outcome key
    om-0003
    source section id
    NCT00261846-om-0003
    source outcome index
    3
    endpoint
    Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1
    endpoint definition
    Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1
    time origin
    0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Evaluable population included all enrolled participants who received at least one dose of study medication and had an adequate baseline efficacy assessment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00261846
    outcome key
    om-0004
    source section id
    NCT00261846-om-0004
    source outcome index
    4
    endpoint
    Plasma Decay Half-Life (t1/2) - Part 1
    endpoint definition
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. NA = not estimable.
    time origin
    0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00261846
    outcome key
    om-0005
    source section id
    NCT00261846-om-0005
    source outcome index
    5
    endpoint
    Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC(0-48)] - Part 1
    endpoint definition
    AUC(0-48)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-48).
    time origin
    0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00261846
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Bosutinib 400 mg (Part 1)
    regimen
    Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00261846-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00261846
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Bosutinib 500 mg (Part 1)
    regimen
    Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00261846-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00261846
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Bosutinib 600 mg (Part 1)
    regimen
    Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
    analyzed count
    12
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00261846-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00261846
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Bosutinib 400 mg (Part 1)
    regimen
    Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00261846-om-0001#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00261846
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Bosutinib 500 mg (Part 1)
    regimen
    Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00261846-om-0001#groups/OG001
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00261846
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Bosutinib 600 mg (Part 1)
    regimen
    Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
    analyzed count
    12
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00261846-om-0001#groups/OG002
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00261846
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Bosutinib 400 mg (Part 1)
    regimen
    Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00261846-om-0002#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00261846
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Bosutinib 500 mg (Part 1)
    regimen
    Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00261846-om-0002#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00261846
    outcome key
    om-0002
    arm key
    OG002
    arm label
    Bosutinib 600 mg (Part 1)
    regimen
    Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
    analyzed count
    12
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00261846-om-0002#groups/OG002
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00261846
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Bosutinib 400 mg (Part 1)
    regimen
    Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00261846-om-0003#groups/OG000
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00261846
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Bosutinib 500 mg (Part 1)
    regimen
    Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00261846-om-0003#groups/OG001
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00261846
    outcome key
    om-0003
    arm key
    OG002
    arm label
    Bosutinib 600 mg (Part 1)
    regimen
    Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
    analyzed count
    12
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00261846-om-0003#groups/OG002
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00261846
    harm key
    EG000
    source section id
    NCT00261846-ae
    event group key
    EG000
    event group label
    Bosutinib 500 mg, CP2L-CML IM-R (Part 2)
    serious affected
    81
    serious at risk
    195
    other affected
    194
    other at risk
    195
    frequency threshold
    5
    collection period
    Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
    event definition
    An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00261846
    harm key
    EG001
    source section id
    NCT00261846-ae
    event group key
    EG001
    event group label
    Bosutinib 500 mg, CP2L-CML IM-I (Part 2)
    serious affected
    34
    serious at risk
    89
    other affected
    89
    other at risk
    89
    frequency threshold
    5
    collection period
    Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
    event definition
    An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00261846
    harm key
    EG002
    source section id
    NCT00261846-ae
    event group key
    EG002
    event group label
    Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)
    serious affected
    1
    serious at risk
    5
    other affected
    5
    other at risk
    5
    frequency threshold
    5
    collection period
    Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
    event definition
    An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00261846
    harm key
    EG003
    source section id
    NCT00261846-ae
    event group key
    EG003
    event group label
    Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)
    serious affected
    15
    serious at risk
    38
    other affected
    38
    other at risk
    38
    frequency threshold
    5
    collection period
    Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
    event definition
    An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00261846
    harm key
    EG004
    source section id
    NCT00261846-ae
    event group key
    EG004
    event group label
    Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)
    serious affected
    19
    serious at risk
    50
    other affected
    50
    other at risk
    50
    frequency threshold
    5
    collection period
    Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
    event definition
    An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00261846
    harm key
    EG005
    source section id
    NCT00261846-ae
    event group key
    EG005
    event group label
    Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
    serious affected
    5
    serious at risk
    26
    other affected
    26
    other at risk
    26
    frequency threshold
    5
    collection period
    Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
    event definition
    An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00261846
    harm key
    EG006
    source section id
    NCT00261846-ae
    event group key
    EG006
    event group label
    AP-CML Total (Part 2)
    serious affected
    43
    serious at risk
    79
    other affected
    79
    other at risk
    79
    frequency threshold
    5
    collection period
    Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
    event definition
    An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00261846
    harm key
    EG007
    source section id
    NCT00261846-ae
    event group key
    EG007
    event group label
    BP-CML Total (Part 2)
    serious affected
    37
    serious at risk
    64
    other affected
    62
    other at risk
    64
    frequency threshold
    5
    collection period
    Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
    event definition
    An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-myeloid-leukemia
    nct id
    NCT00261846
    harm key
    EG008
    source section id
    NCT00261846-ae
    event group key
    EG008
    event group label
    Bosutinib 500 mg, Ph+ ALL (Part 2)
    serious affected
    17
    serious at risk
    24
    other affected
    23
    other at risk
    24
    frequency threshold
    5
    collection period
    Adverse events (AEs) and serious AEs were assessed from informed consent through and including 30 days after last administration of study treatment or at the End of Treatment Visit, whichever comes last.
    event definition
    An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Part 1 safety data were originally presented in 2011 and are included as cumulative data in the Part 2 final safety results.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice