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NCT00481247 · OUTCOME

Percentage of Participants With Major Molecular Response (MMR) at Any Time

A Phase III Study of Dasatinib vs Imatinib in Patients With Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia · Source last updated 2017-02-15

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
Planned total follow-up duration of 5 years

What was measured

Molecular response was assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).

Analysis population: All randomized participants

Groups in this outcome

Dasatinib

Tablets, oral, dasatinib 100 mg once daily (QD)

Imatinib

Tablets, oral, imatinib 400 mg once daily (QD)

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

Analysis denominator · Participants

GroupSource count
Dasatinib259
Imatinib260

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib76.4Not reportedNot reportedNot reportedNot reported
Imatinib64.2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        76.4
      2. group Id
        OG001
        value
        64.2
denoms
  1. counts
    1. group Id
      OG000
      value
      259
    2. group Id
      OG001
      value
      260
    units
    Participants
description
Molecular response was assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).
groups
  1. description
    Tablets, oral, dasatinib 100 mg once daily (QD)
    id
    OG000
    title
    Dasatinib
  2. description
    Tablets, oral, imatinib 400 mg once daily (QD)
    id
    OG001
    title
    Imatinib
param Type
NUMBER
population Description
All randomized participants
reporting Status
POSTED
time Frame
Planned total follow-up duration of 5 years
title
Percentage of Participants With Major Molecular Response (MMR) at Any Time
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice