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NCT00123487 · OUTCOME

Number of Participants With Best Cytogenic Response (CyR) - Randomized Population

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
Randomization up to 6 Months, 2 Years

What was measured

Cytogenetic assessments were performed only for the first 2 years of study. CyR was based on the number of Ph+ metaphases among cells in metaphase on a BM sample. The criteria for CyR were as follows: Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; Partial cytogenetic response (PCyR): 1% to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: 36% to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: 66% to 95% Ph+ cells in metaphase in BM; No cytogenetic response: 96% to 100% Ph+ cells in metaphase in BM.

Analysis population: Participants were analyzed based on the treatment 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 QD306
Dasatinib 70 mg BID305

Reported measurements

Complete CyR, 6 months
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD89Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID84Not reportedNot reportedNot reportedNot reported
Complete CyR, 2 years
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD97Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID98Not reportedNot reportedNot reportedNot reported
Partial CyR, 6 months
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD24Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID36Not reportedNot reportedNot reportedNot reported
Partial CyR, 2 years
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD30Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID28Not reportedNot reportedNot reportedNot reported
Minor CyR, 6 months
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD19Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID18Not reportedNot reportedNot reportedNot reported
Minor CyR, 2 years
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD13Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID16Not reportedNot reportedNot reportedNot reported
Minimal CyR, 6 months
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD47Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID45Not reportedNot reportedNot reportedNot reported
Minimal CyR, 2 years
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD43Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID40Not reportedNot reportedNot reportedNot reported
No response, 6 months
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD63Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID56Not reportedNot reportedNot reportedNot reported
No response, 2 years
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD60Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID51Not reportedNot reportedNot reportedNot reported
Unable to determine, 6 months
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD64Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID66Not reportedNot reportedNot reportedNot reported
Unable to determine, 2 years
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD63Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID72Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        89
      2. group Id
        OG001
        value
        84
    title
    Complete CyR, 6 months
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        97
      2. group Id
        OG001
        value
        98
    title
    Complete CyR, 2 years
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        24
      2. group Id
        OG001
        value
        36
    title
    Partial CyR, 6 months
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        30
      2. group Id
        OG001
        value
        28
    title
    Partial CyR, 2 years
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        18
    title
    Minor CyR, 6 months
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        16
    title
    Minor CyR, 2 years
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        47
      2. group Id
        OG001
        value
        45
    title
    Minimal CyR, 6 months
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        43
      2. group Id
        OG001
        value
        40
    title
    Minimal CyR, 2 years
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        63
      2. group Id
        OG001
        value
        56
    title
    No response, 6 months
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        60
      2. group Id
        OG001
        value
        51
    title
    No response, 2 years
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        64
      2. group Id
        OG001
        value
        66
    title
    Unable to determine, 6 months
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        63
      2. group Id
        OG001
        value
        72
    title
    Unable to determine, 2 years
denoms
  1. counts
    1. group Id
      OG000
      value
      306
    2. group Id
      OG001
      value
      305
    units
    Participants
description
Cytogenetic assessments were performed only for the first 2 years of study. CyR was based on the number of Ph+ metaphases among cells in metaphase on a BM sample. The criteria for CyR were as follows: Complete cytogenetic response (CCyR): 0% Ph+ cells in metaphase in BM; Partial cytogenetic response (PCyR): 1% to 35% Ph+ cells in metaphase in BM; Minor cytogenetic response: 36% to 65% Ph+ cells in metaphase in BM; Minimal cytogenetic response: 66% to 95% Ph+ cells in metaphase in BM; No cytogenetic response: 96% to 100% Ph+ cells in metaphase in BM.
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
Participants were analyzed based on the treatment they were randomized to receive.
reporting Status
POSTED
time Frame
Randomization up to 6 Months, 2 Years
title
Number of Participants With Best Cytogenic Response (CyR) - Randomized Population
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice