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NCT01460160 · OUTCOME

Number of Participants Experiencing Adverse Events

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From first dose to 100 days following last dose (up to approximately 23 months)

What was measured

Number of participants experiencing different types of all causality all grade adverse events

Analysis population: All treated participants

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

Adverse Events (AEs)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib Cohort106Not reportedNot reportedNot reportedNot reported
Drug-related AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib Cohort88Not reportedNot reportedNot reportedNot reported
AEs leading to discontinuation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib Cohort7Not reportedNot reportedNot reportedNot reported
Serious Adverse Events (SAEs)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib Cohort101Not reportedNot reportedNot reportedNot reported
Deaths
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib Cohort15Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        106
    title
    Adverse Events (AEs)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        88
    title
    Drug-related AEs
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    AEs leading to discontinuation
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        101
    title
    Serious Adverse Events (SAEs)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        15
    title
    Deaths
denoms
  1. counts
    1. group Id
      OG000
      value
      106
    units
    Participants
description
Number of participants experiencing different types of all causality all grade adverse events
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
COUNT_OF_PARTICIPANTS
population Description
All treated participants
reporting Status
POSTED
time Frame
From first dose to 100 days following last dose (up to approximately 23 months)
title
Number of Participants Experiencing Adverse Events
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice