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NCT00123487 · OUTCOME

Number of Participants With Grade 4 Myelosuppression Determined From Hematology Evaluations

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
Day 1 up to Year 7

What was measured

Laboratory abnormalities were graded according to the National Cancer Institute Common Terminology Criteria (NCI CTC) Version 3.0. Grade 4 hematology evaluations used to determine myelosuppression included: WBC: \<1.0\*10\^9/L. ANC: \<0.5\*10\^9/L. Platelet count \<25.0 to 10\^9/L.

Analysis population: All participants who received at least one dose of study drug and had laboratory evaluations available were analyzed. Participants were analyzed based on the treatment they actually received, not what 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 QD299
Dasatinib 70 mg BID303

Reported measurements

WBC (n=299, 303)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD64Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID72Not reportedNot reportedNot reportedNot reported
Platelets(n=299, 303)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD167Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID164Not reportedNot reportedNot reportedNot reported
ANC (n=299, 303)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD132Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID142Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        64
      2. group Id
        OG001
        value
        72
    title
    WBC (n=299, 303)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        167
      2. group Id
        OG001
        value
        164
    title
    Platelets(n=299, 303)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        132
      2. group Id
        OG001
        value
        142
    title
    ANC (n=299, 303)
denoms
  1. counts
    1. group Id
      OG000
      value
      299
    2. group Id
      OG001
      value
      303
    units
    Participants
description
Laboratory abnormalities were graded according to the National Cancer Institute Common Terminology Criteria (NCI CTC) Version 3.0. Grade 4 hematology evaluations used to determine myelosuppression included: WBC: \<1.0\*10\^9/L. ANC: \<0.5\*10\^9/L. Platelet count \<25.0 to 10\^9/L.
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
All participants who received at least one dose of study drug and had laboratory evaluations available were analyzed. Participants were analyzed based on the treatment they actually received, not what they were randomized to receive.
reporting Status
POSTED
time Frame
Day 1 up to Year 7
title
Number of Participants With Grade 4 Myelosuppression Determined From Hematology Evaluations
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice