Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00481247 · OUTCOME

Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months

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
Participants
Interval / dispersion
Not reported
Time frame
Pretreatment, every 3 months up to 12 months

What was measured

Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells in metaphase from bone marrow (BM) sample. (Ideally, 25 metaphases but at least 20 metaphases from a BM sample were evaluated). Complete Cytogenetic Response (CCyR)=0% Ph+ cells in metaphase in BM. A cCCyR=those in which all measurements up to at least 28 days after the initial response show an equivalent or better CCyR.

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 Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib204Not reportedNot reportedNot reportedNot reported
Imatinib177Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0056
    p Value Comment
    A priori threshold for statistical significance=0.05.
    statistical Comment
    Cochran-Mantel-Haenszel test stratified by Hasford Score.
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0056
    p Value Comment
    A priori threshold for statistical significance=0.05.
    statistical Comment
    Cochran-Mantel-Haenszel test stratified by Hasford Score.
    statistical Method
    Cochran-Mantel-Haenszel
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        204
      2. group Id
        OG001
        value
        177
denoms
  1. counts
    1. group Id
      OG000
      value
      259
    2. group Id
      OG001
      value
      260
    units
    Participants
description
Cytogenetic response (CyR) is based on the prevalence of Philadelphia positive (Ph+) cells in metaphase from bone marrow (BM) sample. (Ideally, 25 metaphases but at least 20 metaphases from a BM sample were evaluated). Complete Cytogenetic Response (CCyR)=0% Ph+ cells in metaphase in BM. A cCCyR=those in which all measurements up to at least 28 days after the initial response show an equivalent or better CCyR.
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
Pretreatment, every 3 months up to 12 months
title
Number of Participants With Best Confirmed Complete Cytogenetic Response (cCCyR) Within 12 Months
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice