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NCT00123487 · OUTCOME

Number of Participants With Best Confirmed Hematologic Response, Major Hematologic Response (MaHR) and Overall Hematologic Response - 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
participants
Interval / dispersion
Not reported
Time frame
Randomization up to 6 months, 2 years

What was measured

Type of hematologic response: CHR defined as: WBC ≤ ULN; ANC ≥ 1,000/mm\^3; - platelets ≥ 100,000/mm\^3; - no blasts or promyelocytes in PB; 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 the same criteria as CHR except that platelets and ANC had to satisfy at least one 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. Minor Hematologic Response (MiHR): \<15% blasts in BM and in PB; \< 30% blasts + promyelocytes in BM and PB; \< 20% basophils in PB; No extra-medullary disease other than spleen and liver. Major hematologic response (MaHR ) was CHR or NEL. Overall hematologic response was CHR or NEL or MiHR.

Analysis population: Participants were analyzed based on the treatment they were randomized to receive.

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

Complete Response, 6 months
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD94Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID96Not reportedNot reportedNot reportedNot reported
Complete Response, 2 years
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD108Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID110Not reportedNot reportedNot reportedNot reported
No Evidence of Leukemia, 6 months
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD53Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID50Not reportedNot reportedNot reportedNot reported
No Evidence of Leukemia, 2 years
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD47Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID42Not reportedNot reportedNot reportedNot reported
Minor Response, 6 months
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD34Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID29Not reportedNot reportedNot reportedNot reported
Minor Response, 2 years
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD29Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID28Not reportedNot reportedNot reportedNot reported
No Response, 6 months
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD125Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID130Not reportedNot reportedNot reportedNot reported
No Response, 2 years
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD122Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID125Not reportedNot reportedNot reportedNot reported
MaHR, 6 months
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD147Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID146Not reportedNot reportedNot reportedNot reported
MaHR, 2 years
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD155Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID152Not reportedNot reportedNot reportedNot reported
Overall Response, 6 months
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD181Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID175Not reportedNot reportedNot reportedNot reported
Overall Response, 2 years
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD184Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID180Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        94
      2. group Id
        OG001
        value
        96
    title
    Complete Response, 6 months
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        108
      2. group Id
        OG001
        value
        110
    title
    Complete Response, 2 years
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        53
      2. group Id
        OG001
        value
        50
    title
    No Evidence of Leukemia, 6 months
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        47
      2. group Id
        OG001
        value
        42
    title
    No Evidence of Leukemia, 2 years
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        34
      2. group Id
        OG001
        value
        29
    title
    Minor Response, 6 months
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        29
      2. group Id
        OG001
        value
        28
    title
    Minor Response, 2 years
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        125
      2. group Id
        OG001
        value
        130
    title
    No Response, 6 months
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        122
      2. group Id
        OG001
        value
        125
    title
    No Response, 2 years
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        147
      2. group Id
        OG001
        value
        146
    title
    MaHR, 6 months
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        155
      2. group Id
        OG001
        value
        152
    title
    MaHR, 2 years
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        181
      2. group Id
        OG001
        value
        175
    title
    Overall Response, 6 months
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        184
      2. group Id
        OG001
        value
        180
    title
    Overall Response, 2 years
denoms
  1. counts
    1. group Id
      OG000
      value
      306
    2. group Id
      OG001
      value
      305
    units
    Participants
description
Type of hematologic response: CHR defined as: WBC ≤ ULN; ANC ≥ 1,000/mm\^3; - platelets ≥ 100,000/mm\^3; - no blasts or promyelocytes in PB; 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 the same criteria as CHR except that platelets and ANC had to satisfy at least one 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. Minor Hematologic Response (MiHR): \<15% blasts in BM and in PB; \< 30% blasts + promyelocytes in BM and PB; \< 20% basophils in PB; No extra-medullary disease other than spleen and liver. Major hematologic response (MaHR ) was CHR or NEL. Overall hematologic response was CHR or NEL or MiHR.
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.
reporting Status
POSTED
time Frame
Randomization up to 6 months, 2 years
title
Number of Participants With Best Confirmed Hematologic Response, Major Hematologic Response (MaHR) and Overall Hematologic Response - Randomized Population
type
SECONDARY
unit Of Measure
participants

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Preserved source evidence · Not medical advice