Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02130557 · OUTCOME

Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities

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

Criteria for ECG abnormalities included heart rate: increase of \>15 bpm from baseline value and \>=120 bpm, decrease of \>15 bpm from baseline value and \<=45 bpm; PR interval: change of \>=20 msec from baseline value and \>=220 milliseconds (msec); QRS interval \>=120 msec; QTcB interval \>500 msec, increase of \>60 msec from baseline; \>450 msec (Men) or \>470 msec (Women). QT interval using Fridericia's correction (QTcF) \>500 msec, increase of \>60 msec from baseline, \>450 msec (Men) or \>470 msec (Women). The number of participants with ECG abnormalities during On-treatment period are reported. On-Treatment was defined as values collected after the date of the first dose of test article up until the last date of test article +28 days.

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. Here, "N" signifies number of participants evaluable for this outcome measure.

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
Bosutinib266
Imatinib262

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bosutinib16Not reportedNot reportedNot reportedNot reported
Imatinib13Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        13
denoms
  1. counts
    1. group Id
      OG000
      value
      266
    2. group Id
      OG001
      value
      262
    units
    Participants
description
Criteria for ECG abnormalities included heart rate: increase of \>15 bpm from baseline value and \>=120 bpm, decrease of \>15 bpm from baseline value and \<=45 bpm; PR interval: change of \>=20 msec from baseline value and \>=220 milliseconds (msec); QRS interval \>=120 msec; QTcB interval \>500 msec, increase of \>60 msec from baseline; \>450 msec (Men) or \>470 msec (Women). QT interval using Fridericia's correction (QTcF) \>500 msec, increase of \>60 msec from baseline, \>450 msec (Men) or \>470 msec (Women). The number of participants with ECG abnormalities during On-treatment period are reported. On-Treatment was defined as values collected after the date of the first dose of test article up until the last date of test article +28 days.
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. Here, "N" signifies number of participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Baseline up to end of treatment (up to Month 60)
title
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
type
OTHER_PRE_SPECIFIED
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice