Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00123487 · OUTCOME

Number of Participants With Maximal QTcF Intervals 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 up to Year 2

What was measured

A12-lead ECG was obtained at baseline (baseline=within 2 weeks prior to randomization) and once between Day 8 and 29. Additional ECGs were done at the Investigator's discretion. ECGs were read centrally. QT Interval corrected with Fridericia formula was measured in msec.

Analysis population: All participants who received at least one dose of study drug and had appropriate 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 QD280
Dasatinib 70 mg BID270

Reported measurements

Maximum QTcF Interval < 450 msec
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD252Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID239Not reportedNot reportedNot reportedNot reported
Maximum QTcF Interval 450 - 500 msec
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD21Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID26Not reportedNot reportedNot reportedNot reported
Maximum QTcF Interval > 500 msec
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD7Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        252
      2. group Id
        OG001
        value
        239
    title
    Maximum QTcF Interval < 450 msec
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        26
    title
    Maximum QTcF Interval 450 - 500 msec
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        5
    title
    Maximum QTcF Interval > 500 msec
denoms
  1. counts
    1. group Id
      OG000
      value
      280
    2. group Id
      OG001
      value
      270
    units
    Participants
description
A12-lead ECG was obtained at baseline (baseline=within 2 weeks prior to randomization) and once between Day 8 and 29. Additional ECGs were done at the Investigator's discretion. ECGs were read centrally. QT Interval corrected with Fridericia formula was measured in 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 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 up to Year 2
title
Number of Participants With Maximal QTcF Intervals 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