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NCT00123487 · OUTCOME

Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation and Drug-related Fluid Retention AEs, up to Year 7 in Treated Participants

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 to Year 7

What was measured

With protocol Amendment 6, the duration of the study was extended for 2 additional years (7 years total) for participants who continued to have clinical benefit and no feasible alternate access to dasatinib. However, after Year 5 the requirement to follow participants for survival and to collect other efficacy data was removed from the protocol for the remainder of the study. Only AEs and SAEs were collected up to Year 7. On-study AEs and SAEs were graded by severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. The investigator AE terms were coded and grouped by preferred term and system organ class using the Medical Dictionary for Regulatory Activities (MedDRA), version 16.0.

Analysis population: All participants who received at least one dose of study drug 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 QD304
Dasatinib 70 mg BID305

Reported measurements

Deaths
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD203Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID186Not reportedNot reportedNot reportedNot reported
Death within 30 Days
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD66Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID63Not reportedNot reportedNot reportedNot reported
SAEs
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD228Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID236Not reportedNot reportedNot reportedNot reported
AEs Leading to Discontinuation
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD118Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID114Not reportedNot reportedNot reportedNot reported
Drug-related Fluid Retention
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 140 mg QD109Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg BID137Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        203
      2. group Id
        OG001
        value
        186
    title
    Deaths
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        66
      2. group Id
        OG001
        value
        63
    title
    Death within 30 Days
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        228
      2. group Id
        OG001
        value
        236
    title
    SAEs
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        118
      2. group Id
        OG001
        value
        114
    title
    AEs Leading to Discontinuation
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        109
      2. group Id
        OG001
        value
        137
    title
    Drug-related Fluid Retention
denoms
  1. counts
    1. group Id
      OG000
      value
      304
    2. group Id
      OG001
      value
      305
    units
    Participants
description
With protocol Amendment 6, the duration of the study was extended for 2 additional years (7 years total) for participants who continued to have clinical benefit and no feasible alternate access to dasatinib. However, after Year 5 the requirement to follow participants for survival and to collect other efficacy data was removed from the protocol for the remainder of the study. Only AEs and SAEs were collected up to Year 7. On-study AEs and SAEs were graded by severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. The investigator AE terms were coded and grouped by preferred term and system organ class using the Medical Dictionary for Regulatory Activities (MedDRA), version 16.0.
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 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 to Year 7
title
Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation and Drug-related Fluid Retention AEs, up to Year 7 in Treated Participants
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice