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NCT00123474 · OUTCOME

Percent of Imatinib-Resistant Participants With Progression Free Survival (PFS) 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

PFS= time from randomization until: CHR achieved and participant subsequently no longer met criteria for CHR over 2 weeks; no CHR after receiving maximum dose and an increase in WBC (ie, doubling of the count from the lowest value to \> 20,000/mm\^3 or an increase by \> 50,000/mm\^3 on 2 assessments performed 2 weeks apart); participant met criteria of accelerated phase or blast phase CML; participant had MCyR and subsequently no longer met criteria for MCyR after starting maximum dose; participant had a ≥ 30% absolute increase in number of Ph+ metaphases. Deaths without a reported prior progression were considered to have progressed on the date of death; those who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. When first progression reported during follow-up, it was censored at last on-study assessment. If the first progression reported during follow-up was death, participant considered to have progressed at date of death.

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 QD75.2Not reported66.382.1Not reported
Dasatinib 140 mg QD61.3Not reported52.769.6Not reported
Dasatinib 50 mg BID70.3Not reported60.877.9Not reported
Dasatinib 70 mg BID70.8Not reported61.678.2Not reported
36 Months (n=124,123,124, 127)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib 100 mg QD64.8Not reported55.272.9Not reported
Dasatinib 140 mg QD47.4Not reported37.756.5Not reported
Dasatinib 50 mg BID67.1Not reported57.375.1Not reported
Dasatinib 70 mg BID58.2Not reported48.466.8Not reported
48 Months (n=124,123,124, 127)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib 100 mg QD57.8Not reported48.066.5Not reported
Dasatinib 140 mg QD40.0Not reported30.649.3Not reported
Dasatinib 50 mg BID63.8Not reported53.772.2Not reported
Dasatinib 70 mg BID55.1Not reported45.264.8Not reported
60 Months (n=124,123,124, 127)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib 100 mg QD50.2Not reported40.259.3Not reported
Dasatinib 140 mg QD36.4Not reported27.145.8Not reported
Dasatinib 50 mg BID57.4Not reported46.966.5Not reported
Dasatinib 70 mg BID50.2Not reported40.259.4Not reported
72 Months (n=124,123,124, 127)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib 100 mg QD44.0Not reported34.053.6Not reported
Dasatinib 140 mg QD31.4Not reported22.440.8Not reported
Dasatinib 50 mg BID50.7Not reported40.060.4Not reported
Dasatinib 70 mg BID45.3Not reported35.254.8Not reported
84 Months (n=124,123,124, 127)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib 100 mg QD39.0Not reported29.248.7Not reported
Dasatinib 140 mg QD30.2Not reported21.239.6Not reported
Dasatinib 50 mg BID42.1Not reported31.552.4Not reported
Dasatinib 70 mg BID41.3Not reported31.351.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        66.3
        upper Limit
        82.1
        value
        75.2
      2. group Id
        OG001
        lower Limit
        52.7
        upper Limit
        69.6
        value
        61.3
      3. group Id
        OG002
        lower Limit
        60.8
        upper Limit
        77.9
        value
        70.3
      4. group Id
        OG003
        lower Limit
        61.6
        upper Limit
        78.2
        value
        70.8
    title
    24 Months (n=124,123,124, 127)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        55.2
        upper Limit
        72.9
        value
        64.8
      2. group Id
        OG001
        lower Limit
        37.7
        upper Limit
        56.5
        value
        47.4
      3. group Id
        OG002
        lower Limit
        57.3
        upper Limit
        75.1
        value
        67.1
      4. group Id
        OG003
        lower Limit
        48.4
        upper Limit
        66.8
        value
        58.2
    title
    36 Months (n=124,123,124, 127)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        48.0
        upper Limit
        66.5
        value
        57.8
      2. group Id
        OG001
        lower Limit
        30.6
        upper Limit
        49.3
        value
        40.0
      3. group Id
        OG002
        lower Limit
        53.7
        upper Limit
        72.2
        value
        63.8
      4. group Id
        OG003
        lower Limit
        45.2
        upper Limit
        64.8
        value
        55.1
    title
    48 Months (n=124,123,124, 127)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        40.2
        upper Limit
        59.3
        value
        50.2
      2. group Id
        OG001
        lower Limit
        27.1
        upper Limit
        45.8
        value
        36.4
      3. group Id
        OG002
        lower Limit
        46.9
        upper Limit
        66.5
        value
        57.4
      4. group Id
        OG003
        lower Limit
        40.2
        upper Limit
        59.4
        value
        50.2
    title
    60 Months (n=124,123,124, 127)
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        34.0
        upper Limit
        53.6
        value
        44.0
      2. group Id
        OG001
        lower Limit
        22.4
        upper Limit
        40.8
        value
        31.4
      3. group Id
        OG002
        lower Limit
        40.0
        upper Limit
        60.4
        value
        50.7
      4. group Id
        OG003
        lower Limit
        35.2
        upper Limit
        54.8
        value
        45.3
    title
    72 Months (n=124,123,124, 127)
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        29.2
        upper Limit
        48.7
        value
        39.0
      2. group Id
        OG001
        lower Limit
        21.2
        upper Limit
        39.6
        value
        30.2
      3. group Id
        OG002
        lower Limit
        31.5
        upper Limit
        52.4
        value
        42.1
      4. group Id
        OG003
        lower Limit
        31.3
        upper Limit
        51.0
        value
        41.3
    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
PFS= time from randomization until: CHR achieved and participant subsequently no longer met criteria for CHR over 2 weeks; no CHR after receiving maximum dose and an increase in WBC (ie, doubling of the count from the lowest value to \> 20,000/mm\^3 or an increase by \> 50,000/mm\^3 on 2 assessments performed 2 weeks apart); participant met criteria of accelerated phase or blast phase CML; participant had MCyR and subsequently no longer met criteria for MCyR after starting maximum dose; participant had a ≥ 30% absolute increase in number of Ph+ metaphases. Deaths without a reported prior progression were considered to have progressed on the date of death; those who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. When first progression reported during follow-up, it was censored at last on-study assessment. If the first progression reported during follow-up was death, participant considered to have progressed at date of death.
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 Progression Free Survival (PFS) at 24, 36, 48, 60, 72, and 84 Months Follow-Up
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice