Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00481247 · OUTCOME

Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR)

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
95% Confidence Interval
Time frame
Years 2, 3, 4 and 5

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. Percentage of participants in cCCyR at years 2, 3, 4 and 5 was computed for all randomized participants who achieved cCCyR as measured from the time of first confirmation until the date of progression or death. Participants with cCCyR who neither progress nor die are censored on the date of their last cytogenetic assessment. Participants without cCCyR are considered to have progressed on Day 1.

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

At Year 2
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib98.0Not reported94.799.2Not reported
Imatinib96.9Not reported93.298.6Not reported
At Year 3
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib96.9Not reported93.398.6Not reported
Imatinib95.7Not reported91.697.8Not reported
At Year 4
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib95.6Not reported91.497.8Not reported
Imatinib95.7Not reported91.697.8Not reported
At Year 5
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib93.1Not reported86.596.5Not reported
Imatinib91.0Not reported83.695.2Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.55
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.13
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Hazard Ratio (HR)
    param Value
    0.79
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.55
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.13
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Hazard Ratio (HR)
    param Value
    0.79
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        94.7
        upper Limit
        99.2
        value
        98.0
      2. group Id
        OG001
        lower Limit
        93.2
        upper Limit
        98.6
        value
        96.9
    title
    At Year 2
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        93.3
        upper Limit
        98.6
        value
        96.9
      2. group Id
        OG001
        lower Limit
        91.6
        upper Limit
        97.8
        value
        95.7
    title
    At Year 3
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        91.4
        upper Limit
        97.8
        value
        95.6
      2. group Id
        OG001
        lower Limit
        91.6
        upper Limit
        97.8
        value
        95.7
    title
    At Year 4
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        86.5
        upper Limit
        96.5
        value
        93.1
      2. group Id
        OG001
        lower Limit
        83.6
        upper Limit
        95.2
        value
        91.0
    title
    At Year 5
denoms
  1. counts
    1. group Id
      OG000
      value
      215
    2. group Id
      OG001
      value
      204
    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. Percentage of participants in cCCyR at years 2, 3, 4 and 5 was computed for all randomized participants who achieved cCCyR as measured from the time of first confirmation until the date of progression or death. Participants with cCCyR who neither progress nor die are censored on the date of their last cytogenetic assessment. Participants without cCCyR are considered to have progressed on Day 1.
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
NUMBER
population Description
All randomized participants who achieved cCCyR
reporting Status
POSTED
time Frame
Years 2, 3, 4 and 5
title
Percentage of Participants Remaining in Confirmed Complete Cytogenetic Response (cCCyR)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice