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NCT00123487 · OUTCOME

Number of Participants With Changes From Baseline in QT Interval Corrected With Fridericia Formula (QTcF) up to Year 2 in Treated Participants

Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML · Source last updated 2014-11-03

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Baseline to Year 2

What was measured

A12-lead electrocardiogram (ECG) was obtained at baseline (baseline=within 2 weeks prior to randomization) and once between Days 8 and 29. Additional ECGs were done at the Investigator's discretion. ECGs were read centrally. The QT interval corrected with Fridericia formula is presented with categories of changes from baseline (BL) in milliseconds (msec).

Analysis population: All participants who received at least one dose of study drug and had appropriate baseline and on-study ECG data available were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive.

Groups in this outcome

Dasatinib 140 mg QD

Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.

Dasatinib 70 mg BID

Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..

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

Analysis denominator · Participants

GroupSource count
Dasatinib 140 mg QD269
Dasatinib 70 mg BID257

Reported measurements

QTcF <-60 msec change from BL
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD4Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID7Not reportedNot reportedNot reportedNot reported
-60 - < -30 msec change from BL
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD13Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID15Not reportedNot reportedNot reportedNot reported
-30 - < 0 msec change from BL
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD88Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID65Not reportedNot reportedNot reportedNot reported
0 - 30 msec change from BL
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD114Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID125Not reportedNot reportedNot reportedNot reported
> 30 - 60 msec change from BL
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD31Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID24Not reportedNot reportedNot reportedNot reported
> 60 msec change from BL
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD19Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID21Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        7
    title
    QTcF <-60 msec change from BL
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        15
    title
    -60 - < -30 msec change from BL
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        88
      2. group Id
        OG001
        value
        65
    title
    -30 - < 0 msec change from BL
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        114
      2. group Id
        OG001
        value
        125
    title
    0 - 30 msec change from BL
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        31
      2. group Id
        OG001
        value
        24
    title
    > 30 - 60 msec change from BL
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        21
    title
    > 60 msec change from BL
denoms
  1. counts
    1. group Id
      OG000
      value
      269
    2. group Id
      OG001
      value
      257
    units
    Participants
description
A12-lead electrocardiogram (ECG) was obtained at baseline (baseline=within 2 weeks prior to randomization) and once between Days 8 and 29. Additional ECGs were done at the Investigator's discretion. ECGs were read centrally. The QT interval corrected with Fridericia formula is presented with categories of changes from baseline (BL) in milliseconds (msec).
groups
  1. description
    Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
    id
    OG000
    title
    Dasatinib 140 mg QD
  2. description
    Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
    id
    OG001
    title
    Dasatinib 70 mg BID
param Type
NUMBER
population Description
All participants who received at least one dose of study drug and had appropriate baseline and on-study ECG data available were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive.
reporting Status
POSTED
time Frame
Baseline to Year 2
title
Number of Participants With Changes From Baseline in QT Interval Corrected With Fridericia Formula (QTcF) up to Year 2 in Treated Participants
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice