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NCT00123474 · OUTCOME

Percent of Imatinib Intolerant Participants With Overall Survival After 24, 36, 48, 60, 72, and 84 Months of 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-intolerant participants were summarized.

Groups in this outcome

100mg QD

Participants received 100 mg QD 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.

140mg QD

Participants received 140 mg QD 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.

50mg BID

Participants received 50 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.

70mg 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.

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

Analysis denominator · Participants

GroupSource count
100mg QD43
140mg QD44
50mg BID44
70mg BID42

Reported measurements

24 Months (n=43,44,44,42)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
100mg QD94.9Not reported81.298.7Not reported
140mg QD92.8Not reported79.297.6Not reported
50mg BID95.3Not reported82.598.8Not reported
70mg BID97.4Not reported82.899.6Not reported
36 Months (n=43,44,44,42)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
100mg QD89.7Not reported74.996.0Not reported
140mg QD92.8Not reported79.297.6Not reported
50mg BID90.4Not reported76.496.3Not reported
70mg BID94.7Not reported80.698.7Not reported
48 Months (n=43,44,44,42)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
100mg QD84.5Not reported68.692.7Not reported
140mg QD87.5Not reported72.494.6Not reported
50mg BID85.1Not reported69.793.0Not reported
70mg BID86.8Not reported71.294.3Not reported
60 Months (n=43,44,44,42)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
100mg QD81.8Not reported65.690.9Not reported
140mg QD87.5Not reported72.494.6Not reported
50mg BID82.4Not reported66.691.2Not reported
70mg BID81.1Not reported64.390.5Not reported
72 Months (n=43,44,44,42)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
100mg QD79.0Not reported62.388.9Not reported
140mg QD87.5Not reported72.494.6Not reported
50mg BID79.6Not reported63.289.3Not reported
70mg BID81.1Not reported64.390.5Not reported
84 Months (n=43,44,44,42)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
100mg QD70.0Not reported52.282.2Not reported
140mg QD87.5Not reported72.494.6Not reported
50mg BID76.6Not reported59.787.2Not reported
70mg BID77.7Not reported60.188.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        81.2
        upper Limit
        98.7
        value
        94.9
      2. group Id
        OG001
        lower Limit
        79.2
        upper Limit
        97.6
        value
        92.8
      3. group Id
        OG002
        lower Limit
        82.5
        upper Limit
        98.8
        value
        95.3
      4. group Id
        OG003
        lower Limit
        82.8
        upper Limit
        99.6
        value
        97.4
    title
    24 Months (n=43,44,44,42)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        74.9
        upper Limit
        96.0
        value
        89.7
      2. group Id
        OG001
        lower Limit
        79.2
        upper Limit
        97.6
        value
        92.8
      3. group Id
        OG002
        lower Limit
        76.4
        upper Limit
        96.3
        value
        90.4
      4. group Id
        OG003
        lower Limit
        80.6
        upper Limit
        98.7
        value
        94.7
    title
    36 Months (n=43,44,44,42)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        68.6
        upper Limit
        92.7
        value
        84.5
      2. group Id
        OG001
        lower Limit
        72.4
        upper Limit
        94.6
        value
        87.5
      3. group Id
        OG002
        lower Limit
        69.7
        upper Limit
        93.0
        value
        85.1
      4. group Id
        OG003
        lower Limit
        71.2
        upper Limit
        94.3
        value
        86.8
    title
    48 Months (n=43,44,44,42)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        65.6
        upper Limit
        90.9
        value
        81.8
      2. group Id
        OG001
        lower Limit
        72.4
        upper Limit
        94.6
        value
        87.5
      3. group Id
        OG002
        lower Limit
        66.6
        upper Limit
        91.2
        value
        82.4
      4. group Id
        OG003
        lower Limit
        64.3
        upper Limit
        90.5
        value
        81.1
    title
    60 Months (n=43,44,44,42)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        62.3
        upper Limit
        88.9
        value
        79.0
      2. group Id
        OG001
        lower Limit
        72.4
        upper Limit
        94.6
        value
        87.5
      3. group Id
        OG002
        lower Limit
        63.2
        upper Limit
        89.3
        value
        79.6
      4. group Id
        OG003
        lower Limit
        64.3
        upper Limit
        90.5
        value
        81.1
    title
    72 Months (n=43,44,44,42)
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        52.2
        upper Limit
        82.2
        value
        70.0
      2. group Id
        OG001
        lower Limit
        72.4
        upper Limit
        94.6
        value
        87.5
      3. group Id
        OG002
        lower Limit
        59.7
        upper Limit
        87.2
        value
        76.6
      4. group Id
        OG003
        lower Limit
        60.1
        upper Limit
        88.2
        value
        77.7
    title
    84 Months (n=43,44,44,42)
denoms
  1. counts
    1. group Id
      OG000
      value
      43
    2. group Id
      OG001
      value
      44
    3. group Id
      OG002
      value
      44
    4. group Id
      OG003
      value
      42
    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 QD 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
    OG000
    title
    100mg QD
  2. description
    Participants received 140 mg QD 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.
    id
    OG001
    title
    140mg QD
  3. description
    Participants received 50 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.
    id
    OG002
    title
    50mg 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.
    id
    OG003
    title
    70mg BID
param Type
NUMBER
population Description
All randomized imatinib-intolerant participants were summarized.
reporting Status
POSTED
time Frame
24, 36, 48, 60, 72, and 84 months
title
Percent of Imatinib Intolerant Participants With Overall Survival After 24, 36, 48, 60, 72, and 84 Months of Follow-up
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice