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NCT02130557 · OUTCOME

Number of Participants With Treatment-Emergent Adverse Events by National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.0)

A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia · Source last updated 2021-05-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline up to end of treatment (up to Month 60)

What was measured

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity grading based on NCI CTCAE version 4.0. Grade 1 =mild; Grade 2 =moderate; Grade 3 =severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4 =life-threatening or disabling, urgent intervention indicated; Grade 5 =death. Treatment-emergent events were events between first dose of study drug and up to 60 months that were absent before treatment that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 adverse event, only the maximum CTCAE was reported.

Analysis population: Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated to actual study treatment received.

Groups in this outcome

Bosutinib

Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.

Imatinib

Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Bosutinib268
Imatinib265

Reported measurements

Grade 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib7Not reportedNot reportedNot reportedNot reported
Imatinib24Not reportedNot reportedNot reportedNot reported
Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib61Not reportedNot reportedNot reportedNot reported
Imatinib86Not reportedNot reportedNot reportedNot reported
Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib144Not reportedNot reportedNot reportedNot reported
Imatinib120Not reportedNot reportedNot reportedNot reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib50Not reportedNot reportedNot reportedNot reported
Imatinib28Not reportedNot reportedNot reportedNot reported
Grade 5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib3Not reportedNot reportedNot reportedNot reported
Imatinib4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        24
    title
    Grade 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        61
      2. group Id
        OG001
        value
        86
    title
    Grade 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        144
      2. group Id
        OG001
        value
        120
    title
    Grade 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        50
      2. group Id
        OG001
        value
        28
    title
    Grade 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
    title
    Grade 5
denoms
  1. counts
    1. group Id
      OG000
      value
      268
    2. group Id
      OG001
      value
      265
    units
    Participants
description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity grading based on NCI CTCAE version 4.0. Grade 1 =mild; Grade 2 =moderate; Grade 3 =severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4 =life-threatening or disabling, urgent intervention indicated; Grade 5 =death. Treatment-emergent events were events between first dose of study drug and up to 60 months that were absent before treatment that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 adverse event, only the maximum CTCAE was reported.
groups
  1. description
    Participants with Philadelphia chromosome-positive CML received bosutinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
    id
    OG000
    title
    Bosutinib
  2. description
    Participants with Philadelphia chromosome-positive CML received imatinib tablets at a dose of 400 mg, orally once daily in the core treatment phase of 12 months and continued the same treatment into the extension phase or followed up for safety for up to approximately 4 years, until the end of the study, treatment failure, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first.
    id
    OG001
    title
    Imatinib
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety population included all participants who received at least 1 dose of study medication with treatment assignments designated to actual study treatment received.
reporting Status
POSTED
time Frame
Baseline up to end of treatment (up to Month 60)
title
Number of Participants With Treatment-Emergent Adverse Events by National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.0)
type
OTHER_PRE_SPECIFIED
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice