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NCT00123487 · OUTCOME

Percent of Participants With Major Hematologic Response (MaHR) by Disease Group - 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
Randomization up to 2 years

What was measured

MaHR was defined by either complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR defined as: white blood cells (WBC) ≤ upper limit of normal (ULN); absolute neutrophil count (ANC) ≥ 1,000/mm\^3; platelets ≥ 100,000/mm\^3; no blasts or promyelocytes in peripheral blood (PB); bone marrow (BM) blasts ≤ 5%; \<5% myelocytes plus metamyelocytes in PB; basophils in PB \< 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by same criteria as CHR except that platelets and ANC had to satisfy at least one parameter of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm\^3 and \< 100,000/mm\^3; ANC \> 500/mm\^3 and \<1,000/mm\^3. After Year 2, Amendment 3 allowed participants to switch from the BID to the QD dosing schedule.. Percentage: participants with MaHR/randomized participants.

Analysis population: Participants were analyzed based on the treatment they were randomized to receive. n=number of participants in disease group.

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

Accelerated Phase (n=158, 159)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD66.5Not reported58.573.8Not reported
Dasatinib 70 mg BID67.9Not reported60.175.1Not reported
Myeloid Blast Phase (n=75,74)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD28.0Not reported18.239.6Not reported
Dasatinib 70 mg BID28.4Not reported18.540.1Not reported
Lymphoid Blast Phase (n=33,28)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD42.4Not reported25.560.8Not reported
Dasatinib 70 mg BID32.1Not reported15.952.4Not reported
Ph+ Acute Lymphoblastic Leukemia (n=40,44)
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD37.5Not reported22.754.2Not reported
Dasatinib 70 mg BID31.8Not reported18.647.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        58.5
        upper Limit
        73.8
        value
        66.5
      2. group Id
        OG001
        lower Limit
        60.1
        upper Limit
        75.1
        value
        67.9
    title
    Accelerated Phase (n=158, 159)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        18.2
        upper Limit
        39.6
        value
        28.0
      2. group Id
        OG001
        lower Limit
        18.5
        upper Limit
        40.1
        value
        28.4
    title
    Myeloid Blast Phase (n=75,74)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        25.5
        upper Limit
        60.8
        value
        42.4
      2. group Id
        OG001
        lower Limit
        15.9
        upper Limit
        52.4
        value
        32.1
    title
    Lymphoid Blast Phase (n=33,28)
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22.7
        upper Limit
        54.2
        value
        37.5
      2. group Id
        OG001
        lower Limit
        18.6
        upper Limit
        47.6
        value
        31.8
    title
    Ph+ Acute Lymphoblastic Leukemia (n=40,44)
denoms
  1. counts
    1. group Id
      OG000
      value
      306
    2. group Id
      OG001
      value
      305
    units
    Participants
description
MaHR was defined by either complete hematologic response (CHR) or no evidence of leukemia (NEL). CHR defined as: white blood cells (WBC) ≤ upper limit of normal (ULN); absolute neutrophil count (ANC) ≥ 1,000/mm\^3; platelets ≥ 100,000/mm\^3; no blasts or promyelocytes in peripheral blood (PB); bone marrow (BM) blasts ≤ 5%; \<5% myelocytes plus metamyelocytes in PB; basophils in PB \< 20%; no extra-medullar involvement (including no hepatomegaly or splenomegaly). NEL defined by same criteria as CHR except that platelets and ANC had to satisfy at least one parameter of the following (note that both lower limits had to be satisfied): platelets ≥ 20,000/mm\^3 and \< 100,000/mm\^3; ANC \> 500/mm\^3 and \<1,000/mm\^3. After Year 2, Amendment 3 allowed participants to switch from the BID to the QD dosing schedule.. Percentage: participants with MaHR/randomized participants.
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. n=number of participants in disease group.
reporting Status
POSTED
time Frame
Randomization up to 2 years
title
Percent of Participants With Major Hematologic Response (MaHR) by Disease Group - Randomized Population
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice