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NCT00123474 · OUTCOME

Number of Participants With MCyR and Baseline BCR-ABL Gene Mutation - All Treated Participants

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
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Baseline up to 24 months

What was measured

BCR-ABL mutations were assessed in participants prior to the start of study drug (baseline) and at the time of disease progression or at end of therapy. Quantification of BCR-ABL transcripts in peripheral blood was evaluated using quantitative reverse transcriptase polymerase chain reaction (Q-RT-PCR, RT-PCR).

Analysis population: All randomized, treated participants with available mutation data 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 QD147
Dasatinib 140 mg QD139
Dasatinib 50 mg BID149
Dasatinib 70 mg BID146

Reported measurements

Imatinib-resistant Mutations
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 100 mg QD49Not reportedNot reportedNot reportedNot reported
Dasatinib 140 mg QD49Not reportedNot reportedNot reportedNot reported
Dasatinib 50 mg BID62Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID48Not reportedNot reportedNot reportedNot reported
Mutations with unknown Imatinib-resistance status
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 100 mg QD0Not reportedNot reportedNot reportedNot reported
Dasatinib 140 mg QD1Not reportedNot reportedNot reportedNot reported
Dasatinib 50 mg BID1Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID2Not reportedNot reportedNot reportedNot reported
Imatinib Resistant or unknown mutations
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 100 mg QD49Not reportedNot reportedNot reportedNot reported
Dasatinib 140 mg QD50Not reportedNot reportedNot reportedNot reported
Dasatinib 50 mg BID63Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID50Not reportedNot reportedNot reportedNot reported
Polymorphisms
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 100 mg QD0Not reportedNot reportedNot reportedNot reported
Dasatinib 140 mg QD2Not reportedNot reportedNot reportedNot reported
Dasatinib 50 mg BID0Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID0Not reportedNot reportedNot reportedNot reported
No Mutations
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 100 mg QD98Not reportedNot reportedNot reportedNot reported
Dasatinib 140 mg QD87Not reportedNot reportedNot reportedNot reported
Dasatinib 50 mg BID86Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID96Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        49
      2. group Id
        OG001
        value
        49
      3. group Id
        OG002
        value
        62
      4. group Id
        OG003
        value
        48
    title
    Imatinib-resistant Mutations
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        2
    title
    Mutations with unknown Imatinib-resistance status
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        49
      2. group Id
        OG001
        value
        50
      3. group Id
        OG002
        value
        63
      4. group Id
        OG003
        value
        50
    title
    Imatinib Resistant or unknown mutations
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Polymorphisms
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        98
      2. group Id
        OG001
        value
        87
      3. group Id
        OG002
        value
        86
      4. group Id
        OG003
        value
        96
    title
    No Mutations
denoms
  1. counts
    1. group Id
      OG000
      value
      147
    2. group Id
      OG001
      value
      139
    3. group Id
      OG002
      value
      149
    4. group Id
      OG003
      value
      146
    units
    Participants
description
BCR-ABL mutations were assessed in participants prior to the start of study drug (baseline) and at the time of disease progression or at end of therapy. Quantification of BCR-ABL transcripts in peripheral blood was evaluated using quantitative reverse transcriptase polymerase chain reaction (Q-RT-PCR, RT-PCR).
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
NUMBER
population Description
All randomized, treated participants with available mutation data were summarized.
reporting Status
POSTED
time Frame
Baseline up to 24 months
title
Number of Participants With MCyR and Baseline BCR-ABL Gene Mutation - All Treated Participants
type
SECONDARY
unit Of Measure
participants

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Preserved source evidence · Not medical advice