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NCT00481247 · OUTCOME

Time to Confirmed Complete Cytogenic Response (cCCyR) Overall

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Day 1 to 5 years

What was measured

The time to cCCyR for all randomized participants is defined as the time from the randomization date until criteria are first met for complete cytogenic response (provided it is confirmed later). The time to cCCyR analysis censors nonresponders who do not progress at their last cytogenetic assessments and nonresponders who progress at the maximum time of all randomized participants. .

Analysis population: All randomized participants who achieved cCCyR

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
Dasatinib215
Imatinib204

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib3.1Not reported3.03.1Not reported
Imatinib5.8Not reported5.66.0Not reported

Source statistical analyses

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

  1. ci Lower Limit
    1.20
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.77
    group Description
    Hazard Ratio and Confidence Interval were based on analyses on all randomized subjects
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Hazard Ratio (HR)
    param Value
    1.46
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    1.20
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.77
    group Description
    Hazard Ratio and Confidence Interval were based on analyses on all randomized subjects
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Hazard Ratio (HR)
    param Value
    1.46
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.0
        upper Limit
        3.1
        value
        3.1
      2. group Id
        OG001
        lower Limit
        5.6
        upper Limit
        6.0
        value
        5.8
denoms
  1. counts
    1. group Id
      OG000
      value
      215
    2. group Id
      OG001
      value
      204
    units
    Participants
description
The time to cCCyR for all randomized participants is defined as the time from the randomization date until criteria are first met for complete cytogenic response (provided it is confirmed later). The time to cCCyR analysis censors nonresponders who do not progress at their last cytogenetic assessments and nonresponders who progress at the maximum time of all randomized participants. .
dispersion Type
95% Confidence Interval
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
MEDIAN
population Description
All randomized participants who achieved cCCyR
reporting Status
POSTED
time Frame
Day 1 to 5 years
title
Time to Confirmed Complete Cytogenic Response (cCCyR) Overall
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice