Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00123474 · OUTCOME

Percent of Imatinib-Resistant Participants With Overall Survival (OS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up

Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML · Source last updated 2016-08-25

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
24, 36, 48, 60, 72, and 84 months

What was measured

Overall survival (OS) was defined as the time from randomization until death. Survival data were collected for up to 5 years on participants who had discontinued dasatinib treatment. Participants who did not die or who were lost to follow-up were censored on the last date the participant was known to be alive.

Analysis population: All randomized imatinib-resistant participants were summarized.

Groups in this outcome

Dasatinib 100 mg QD

Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.

Dasatinib 140 mg QD

Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.

Dasatinib 50 mg BID

Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.

Dasatinib 70 mg BID

Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.

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 100 mg QD124
Dasatinib 140 mg QD123
Dasatinib 50 mg BID124
Dasatinib 70 mg BID126

Reported measurements

24 Months (n=124,123,124,127)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib 100 mg QD90.1Not reported83.294.2Not reported
Dasatinib 140 mg QD93.9Not reported87.697.0Not reported
Dasatinib 50 mg BID88.9Not reported81.693.4Not reported
Dasatinib 70 mg BID85.1Not reported77.390.3Not reported
36 Months (n=124,123,124,127)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib 100 mg QD87.5Not reported80.292.3Not reported
Dasatinib 140 mg QD83.8Not reported75.689.5Not reported
Dasatinib 50 mg BID83.5Not reported75.389.1Not reported
Dasatinib 70 mg BID76.5Not reported67.783.1Not reported
48 Months (n=124,123,124,127)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib 100 mg QD79.7Not reported71.385.9Not reported
Dasatinib 140 mg QD82.0Not reported73.488.0Not reported
Dasatinib 50 mg BID80.7Not reported72.186.9Not reported
Dasatinib 70 mg BID71.1Not reported61.978.4Not reported
60 Months (n=124,123,124,127)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib 100 mg QD75.1Not reported66.182.0Not reported
Dasatinib 140 mg QD78.0Not reported68.984.7Not reported
Dasatinib 50 mg BID73.6Not reported64.180.9Not reported
Dasatinib 70 mg BID69.1Not reported59.876.7Not reported
72 Months (n=124,123,124,127)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib 100 mg QD67.9Not reported58.375.8Not reported
Dasatinib 140 mg QD72.6Not reported62.980.1Not reported
Dasatinib 50 mg BID71.4Not reported61.879.0Not reported
Dasatinib 70 mg BID67.1Not reported57.674.9Not reported
84 Months (n=124,123,124,127)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib 100 mg QD62.6Not reported52.671.0Not reported
Dasatinib 140 mg QD68.1Not reported58.076.2Not reported
Dasatinib 50 mg BID67.9Not reported57.976.0Not reported
Dasatinib 70 mg BID65.0Not reported55.373.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        83.2
        upper Limit
        94.2
        value
        90.1
      2. group Id
        OG001
        lower Limit
        87.6
        upper Limit
        97.0
        value
        93.9
      3. group Id
        OG002
        lower Limit
        81.6
        upper Limit
        93.4
        value
        88.9
      4. group Id
        OG003
        lower Limit
        77.3
        upper Limit
        90.3
        value
        85.1
    title
    24 Months (n=124,123,124,127)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        80.2
        upper Limit
        92.3
        value
        87.5
      2. group Id
        OG001
        lower Limit
        75.6
        upper Limit
        89.5
        value
        83.8
      3. group Id
        OG002
        lower Limit
        75.3
        upper Limit
        89.1
        value
        83.5
      4. group Id
        OG003
        lower Limit
        67.7
        upper Limit
        83.1
        value
        76.5
    title
    36 Months (n=124,123,124,127)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        71.3
        upper Limit
        85.9
        value
        79.7
      2. group Id
        OG001
        lower Limit
        73.4
        upper Limit
        88.0
        value
        82.0
      3. group Id
        OG002
        lower Limit
        72.1
        upper Limit
        86.9
        value
        80.7
      4. group Id
        OG003
        lower Limit
        61.9
        upper Limit
        78.4
        value
        71.1
    title
    48 Months (n=124,123,124,127)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        66.1
        upper Limit
        82.0
        value
        75.1
      2. group Id
        OG001
        lower Limit
        68.9
        upper Limit
        84.7
        value
        78.0
      3. group Id
        OG002
        lower Limit
        64.1
        upper Limit
        80.9
        value
        73.6
      4. group Id
        OG003
        lower Limit
        59.8
        upper Limit
        76.7
        value
        69.1
    title
    60 Months (n=124,123,124,127)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        58.3
        upper Limit
        75.8
        value
        67.9
      2. group Id
        OG001
        lower Limit
        62.9
        upper Limit
        80.1
        value
        72.6
      3. group Id
        OG002
        lower Limit
        61.8
        upper Limit
        79.0
        value
        71.4
      4. group Id
        OG003
        lower Limit
        57.6
        upper Limit
        74.9
        value
        67.1
    title
    72 Months (n=124,123,124,127)
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        52.6
        upper Limit
        71.0
        value
        62.6
      2. group Id
        OG001
        lower Limit
        58.0
        upper Limit
        76.2
        value
        68.1
      3. group Id
        OG002
        lower Limit
        57.9
        upper Limit
        76.0
        value
        67.9
      4. group Id
        OG003
        lower Limit
        55.3
        upper Limit
        73.0
        value
        65.0
    title
    84 Months (n=124,123,124,127)
denoms
  1. counts
    1. group Id
      OG000
      value
      124
    2. group Id
      OG001
      value
      123
    3. group Id
      OG002
      value
      124
    4. group Id
      OG003
      value
      126
    units
    Participants
description
Overall survival (OS) was defined as the time from randomization until death. Survival data were collected for up to 5 years on participants who had discontinued dasatinib treatment. Participants who did not die or who were lost to follow-up were censored on the last date the participant was known to be alive.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
    id
    OG000
    title
    Dasatinib 100 mg QD
  2. description
    Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
    id
    OG001
    title
    Dasatinib 140 mg QD
  3. description
    Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
    id
    OG002
    title
    Dasatinib 50 mg BID
  4. description
    Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
    id
    OG003
    title
    Dasatinib 70 mg BID
param Type
NUMBER
population Description
All randomized imatinib-resistant participants were summarized.
reporting Status
POSTED
time Frame
24, 36, 48, 60, 72, and 84 months
title
Percent of Imatinib-Resistant Participants With Overall Survival (OS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice