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NCT00123487 · OUTCOME

Progression Free Survival (PFS) and Overall Survival (OS) at 24, 36, 48, and 60 Months - Randomized Population

Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML · Source last updated 2014-11-03

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 months, 36 months, 48 months, 60 months

What was measured

PFS was defined as time from randomization until any of the following: Progression of disease (per investigator), or death. For those with blast phase CML or Ph+ ALL, disease progression was: loss of OHR; no decrease from on-study baseline percent blasts in PB or BM on all assessments over a 4-week period after starting maximum dose; absolute increase of at least 50% in PB blast count over a 2-week period after starting maximum dose. For those with accelerated phase CML: the list above also included: Development of blast phase CML at any time after initiation of therapy and development of extra-medullary sites other than spleen or liver. Participants who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. OS was defined as time from randomization until date of death. Participants who had not died or were lost to follow-up were censored on the last date they were known to be alive. Median duration was measured in months.

Analysis population: Participants were analyzed based on the treatment they were randomized to receive. Kaplan-Meir estimates of PFS or OS (95% Confidence Interval) are provided below.

Groups in this outcome

Dasatinib 140 mg QD

Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.

Dasatinib 70 mg BID

Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..

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 140 mg QD306
Dasatinib 70 mg BID305

Reported measurements

PFS at 24 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD29.5Not reported24.234.8Not reported
Dasatinib 70 mg BID33.1Not reported27.438.8Not reported
PFS at 36 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD24.1Not reported19.029.1Not reported
Dasatinib 70 mg BID26.6Not reported21.032.1Not reported
PFS at 48 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD19.8Not reported15.024.6Not reported
Dasatinib 70 mg BID20.5Not reported15.125.9Not reported
PFS at 60 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD16.9Not reported12.321.5Not reported
Dasatinib 70 mg BID15.9Not reported10.521.2Not reported
OS at 24 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD43.3Not reported37.549.0Not reported
Dasatinib 70 mg BID48.7Not reported42.954.5Not reported
OS at 36 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD37.1Not reported31.442.8Not reported
Dasatinib 70 mg BID42.5Not reported36.648.3Not reported
OS at 48 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD32.7Not reported27.138.3Not reported
Dasatinib 70 mg BID38.2Not reported32.444.0Not reported
OS at 60 Months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD28.8Not reported23.434.3Not reported
Dasatinib 70 mg BID36.1Not reported30.341.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        24.2
        upper Limit
        34.8
        value
        29.5
      2. group Id
        OG001
        lower Limit
        27.4
        upper Limit
        38.8
        value
        33.1
    title
    PFS at 24 Months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        19.0
        upper Limit
        29.1
        value
        24.1
      2. group Id
        OG001
        lower Limit
        21.0
        upper Limit
        32.1
        value
        26.6
    title
    PFS at 36 Months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.0
        upper Limit
        24.6
        value
        19.8
      2. group Id
        OG001
        lower Limit
        15.1
        upper Limit
        25.9
        value
        20.5
    title
    PFS at 48 Months
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.3
        upper Limit
        21.5
        value
        16.9
      2. group Id
        OG001
        lower Limit
        10.5
        upper Limit
        21.2
        value
        15.9
    title
    PFS at 60 Months
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        37.5
        upper Limit
        49.0
        value
        43.3
      2. group Id
        OG001
        lower Limit
        42.9
        upper Limit
        54.5
        value
        48.7
    title
    OS at 24 Months
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        31.4
        upper Limit
        42.8
        value
        37.1
      2. group Id
        OG001
        lower Limit
        36.6
        upper Limit
        48.3
        value
        42.5
    title
    OS at 36 Months
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        27.1
        upper Limit
        38.3
        value
        32.7
      2. group Id
        OG001
        lower Limit
        32.4
        upper Limit
        44.0
        value
        38.2
    title
    OS at 48 Months
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        23.4
        upper Limit
        34.3
        value
        28.8
      2. group Id
        OG001
        lower Limit
        30.3
        upper Limit
        41.8
        value
        36.1
    title
    OS at 60 Months
denoms
  1. counts
    1. group Id
      OG000
      value
      306
    2. group Id
      OG001
      value
      305
    units
    Participants
description
PFS was defined as time from randomization until any of the following: Progression of disease (per investigator), or death. For those with blast phase CML or Ph+ ALL, disease progression was: loss of OHR; no decrease from on-study baseline percent blasts in PB or BM on all assessments over a 4-week period after starting maximum dose; absolute increase of at least 50% in PB blast count over a 2-week period after starting maximum dose. For those with accelerated phase CML: the list above also included: Development of blast phase CML at any time after initiation of therapy and development of extra-medullary sites other than spleen or liver. Participants who neither progressed nor died were censored on the date of their last cytogenetic or hematologic assessment. OS was defined as time from randomization until date of death. Participants who had not died or were lost to follow-up were censored on the last date they were known to be alive. Median duration was measured in months.
dispersion Type
95% Confidence Interval
groups
  1. description
    Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
    id
    OG000
    title
    Dasatinib 140 mg QD
  2. description
    Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
    id
    OG001
    title
    Dasatinib 70 mg BID
param Type
NUMBER
population Description
Participants were analyzed based on the treatment they were randomized to receive. Kaplan-Meir estimates of PFS or OS (95% Confidence Interval) are provided below.
reporting Status
POSTED
time Frame
24 months, 36 months, 48 months, 60 months
title
Progression Free Survival (PFS) and Overall Survival (OS) at 24, 36, 48, and 60 Months - Randomized Population
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice