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NCT00123474 · OUTCOME

Time to MCyR in Participants With MCyR at 24 Months Follow-Up

Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML · Source last updated 2016-08-25

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
24 months

What was measured

Time to MCyR was defined as the time from the first dosing date until criteria were first met for CCyR or PCyR, whichever occurred first. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to MCyR response for responders and time to last cytogenetic assessment for non-responders). Cytogenetic assessments were not done after the 2 Year Follow-up.

Analysis population: Randomized imatinib-resistant participants with MCyR were summarized.

Groups in this outcome

Dasatinib 100 mg QD

Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.

Dasatinib 140 mg QD

Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.

Dasatinib 50 mg BID

Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.

Dasatinib 70 mg BID

Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.

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 100 mg QD73
Dasatinib 140 mg QD71
Dasatinib 50 mg BID69
Dasatinib 70 mg BID72

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib 100 mg QD2.9Not reported2.83.4Not reported
Dasatinib 140 mg QD2.8Not reported2.83.0Not reported
Dasatinib 50 mg BID2.9Not reported2.83.3Not reported
Dasatinib 70 mg BID2.9Not reported2.83.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.8
        upper Limit
        3.4
        value
        2.9
      2. group Id
        OG001
        lower Limit
        2.8
        upper Limit
        3.0
        value
        2.8
      3. group Id
        OG002
        lower Limit
        2.8
        upper Limit
        3.3
        value
        2.9
      4. group Id
        OG003
        lower Limit
        2.8
        upper Limit
        3.0
        value
        2.9
denoms
  1. counts
    1. group Id
      OG000
      value
      73
    2. group Id
      OG001
      value
      71
    3. group Id
      OG002
      value
      69
    4. group Id
      OG003
      value
      72
    units
    Participants
description
Time to MCyR was defined as the time from the first dosing date until criteria were first met for CCyR or PCyR, whichever occurred first. Non-responders were censored at the maximum time of all participants in their respective group (ie, maximum between time to MCyR response for responders and time to last cytogenetic assessment for non-responders). Cytogenetic assessments were not done after the 2 Year Follow-up.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
    id
    OG000
    title
    Dasatinib 100 mg QD
  2. description
    Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
    id
    OG001
    title
    Dasatinib 140 mg QD
  3. description
    Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
    id
    OG002
    title
    Dasatinib 50 mg BID
  4. description
    Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
    id
    OG003
    title
    Dasatinib 70 mg BID
param Type
MEDIAN
population Description
Randomized imatinib-resistant participants with MCyR were summarized.
reporting Status
POSTED
time Frame
24 months
title
Time to MCyR in Participants With MCyR at 24 Months Follow-Up
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice