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NCT01460160 · OUTCOME

Percentage of Participants With BCR-ABL Mutations at Baseline and at Time of Disease Progression or Relapse

Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia · Source last updated 2021-12-08

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
Not reported
Time frame
At baseline (prior to start of study treatment) and at disease progression or relapse (up to approximately 3 years)

What was measured

A BCR-ABL mutation is defined as the presence of a detectable amino acid substitution in the ABL kinase domain, assessed by Real-time quantitative PCR.

Analysis population: All treated participants with available measurements

Groups in this outcome

Dasatinib Cohort

Children and adolescents newly diagnosed with Philadelphia chromosome positive acute lymphocytic leukemia (Ph+ ALL) treated with standard multiagent chemotherapy and Dasatinib (either in tablets or Powder For Oral Suspension (PFOS)) at a dose of 60 mg/m2 daily.

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 Cohort106

Reported measurements

At Baseline

Analysis denominator · Participants

GroupSource count
Dasatinib Cohort80
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib Cohort1.3Not reportedNot reportedNot reportedNot reported
At Disease Progression or Relapse

Analysis denominator · Participants

GroupSource count
Dasatinib Cohort31
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib Cohort6.5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        80
      units
      Participants
    title
    At Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        31
      units
      Participants
    title
    At Disease Progression or Relapse
denoms
  1. counts
    1. group Id
      OG000
      value
      106
    units
    Participants
description
A BCR-ABL mutation is defined as the presence of a detectable amino acid substitution in the ABL kinase domain, assessed by Real-time quantitative PCR.
groups
  1. description
    Children and adolescents newly diagnosed with Philadelphia chromosome positive acute lymphocytic leukemia (Ph+ ALL) treated with standard multiagent chemotherapy and Dasatinib (either in tablets or Powder For Oral Suspension (PFOS)) at a dose of 60 mg/m2 daily.
    id
    OG000
    title
    Dasatinib Cohort
param Type
NUMBER
population Description
All treated participants with available measurements
reporting Status
POSTED
time Frame
At baseline (prior to start of study treatment) and at disease progression or relapse (up to approximately 3 years)
title
Percentage of Participants With BCR-ABL Mutations at Baseline and at Time of Disease Progression or Relapse
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice