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NCT00123474 · OUTCOME

Percent of Participants Overall Survival at 24, 36, 48, 60, 72, and 84 Months Follow-Up - All Randomized Participants

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 participants who were randomized to a treatment arm 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. 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 140 mg 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 schedule were allowed to switch to a QD dosing schedule.

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 QD167
Dasatinib 140 mg QD167
Dasatinib 50 mg BID168
Dasatinib 70 mg BID168

Reported measurements

24 Months (n=167, 167, 168, 168)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib 100 mg QD91.3Not reported85.894.8Not reported
Dasatinib 140 mg QD93.6Not reported88.496.5Not reported
Dasatinib 50 mg BID90.6Not reported84.994.2Not reported
Dasatinib 70 mg BID88.1Not reported81.992.2Not reported
36 Months (n=167, 167, 168, 168)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib 100 mg QD88.1Not reported82.092.3Not reported
Dasatinib 140 mg QD86.2Not reported79.690.8Not reported
Dasatinib 50 mg BID85.3Not reported78.790.0Not reported
Dasatinib 70 mg BID80.9Not reported73.986.3Not reported
48 Months (n=167, 167, 168, 168)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib 100 mg QD81.0Not reported73.986.3Not reported
Dasatinib 140 mg QD83.4Not reported76.488.5Not reported
Dasatinib 50 mg BID81.8Not reported74.787.1Not reported
Dasatinib 70 mg BID74.9Not reported67.381.0Not reported
60 Months (n=167, 167, 168, 168)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib 100 mg QD76.8Not reported69.482.7Not reported
Dasatinib 140 mg QD80.5Not reported73.186.0Not reported
Dasatinib 50 mg BID75.9Not reported68.282.0Not reported
Dasatinib 70 mg BID72.0Not reported64.178.4Not reported
72 Months (n=167, 167, 168, 168)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib 100 mg QD70.9Not reported62.977.5Not reported
Dasatinib 140 mg QD76.6Not reported68.782.7Not reported
Dasatinib 50 mg BID73.6Not reported65.680.0Not reported
Dasatinib 70 mg BID70.5Not reported62.577.1Not reported
84 Months (n=167, 167, 168, 168)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib 100 mg QD64.6Not reported56.171.8Not reported
Dasatinib 140 mg QD73.4Not reported65.279.9Not reported
Dasatinib 50 mg BID70.3Not reported62.077.1Not reported
Dasatinib 70 mg BID68.1Not reported59.874.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        85.8
        upper Limit
        94.8
        value
        91.3
      2. group Id
        OG001
        lower Limit
        88.4
        upper Limit
        96.5
        value
        93.6
      3. group Id
        OG002
        lower Limit
        84.9
        upper Limit
        94.2
        value
        90.6
      4. group Id
        OG003
        lower Limit
        81.9
        upper Limit
        92.2
        value
        88.1
    title
    24 Months (n=167, 167, 168, 168)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        82.0
        upper Limit
        92.3
        value
        88.1
      2. group Id
        OG001
        lower Limit
        79.6
        upper Limit
        90.8
        value
        86.2
      3. group Id
        OG002
        lower Limit
        78.7
        upper Limit
        90.0
        value
        85.3
      4. group Id
        OG003
        lower Limit
        73.9
        upper Limit
        86.3
        value
        80.9
    title
    36 Months (n=167, 167, 168, 168)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        73.9
        upper Limit
        86.3
        value
        81.0
      2. group Id
        OG001
        lower Limit
        76.4
        upper Limit
        88.5
        value
        83.4
      3. group Id
        OG002
        lower Limit
        74.7
        upper Limit
        87.1
        value
        81.8
      4. group Id
        OG003
        lower Limit
        67.3
        upper Limit
        81.0
        value
        74.9
    title
    48 Months (n=167, 167, 168, 168)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        69.4
        upper Limit
        82.7
        value
        76.8
      2. group Id
        OG001
        lower Limit
        73.1
        upper Limit
        86.0
        value
        80.5
      3. group Id
        OG002
        lower Limit
        68.2
        upper Limit
        82.0
        value
        75.9
      4. group Id
        OG003
        lower Limit
        64.1
        upper Limit
        78.4
        value
        72.0
    title
    60 Months (n=167, 167, 168, 168)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        62.9
        upper Limit
        77.5
        value
        70.9
      2. group Id
        OG001
        lower Limit
        68.7
        upper Limit
        82.7
        value
        76.6
      3. group Id
        OG002
        lower Limit
        65.6
        upper Limit
        80.0
        value
        73.6
      4. group Id
        OG003
        lower Limit
        62.5
        upper Limit
        77.1
        value
        70.5
    title
    72 Months (n=167, 167, 168, 168)
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        56.1
        upper Limit
        71.8
        value
        64.6
      2. group Id
        OG001
        lower Limit
        65.2
        upper Limit
        79.9
        value
        73.4
      3. group Id
        OG002
        lower Limit
        62.0
        upper Limit
        77.1
        value
        70.3
      4. group Id
        OG003
        lower Limit
        59.8
        upper Limit
        74.9
        value
        68.1
    title
    84 Months (n=167, 167, 168, 168)
denoms
  1. counts
    1. group Id
      OG000
      value
      167
    2. group Id
      OG001
      value
      167
    3. group Id
      OG002
      value
      168
    4. group Id
      OG003
      value
      168
    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. 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
    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. 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
    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 participants who were randomized to a treatment arm were summarized.
reporting Status
POSTED
time Frame
24, 36, 48, 60, 72, and 84 months
title
Percent of Participants Overall Survival at 24, 36, 48, 60, 72, and 84 Months Follow-Up - All Randomized Participants
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice