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NCT01460160 · OUTCOME

Event-Free Survival (EFS) Rate (Kaplan-Meier Estimates)

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
95% Confidence Interval
Time frame
From first dose to 3 years or 5 years following first dose

What was measured

Overall estimation of the EFS of dasatinib plus chemotherapy was performed utilizing the Kaplan-Meier (KM) Product Limit method. The 3-year and 5-year EFS rates were computed with the corresponding 95% CI's using Greenwood's formula. Analyses of EFS included KM plots with number of patients at risk. Participants who neither relapse nor die or who are lost to follow-up were censored on the date of their last bone marrow, CSF assessment or physical exam, whichever occurred last.

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

3-year EFS Estimate
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib Cohort65.5Not reported55.573.7Not reported
5-year EFS Estimate
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib Cohort53.1Not reported42.862.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        55.5
        upper Limit
        73.7
        value
        65.5
    title
    3-year EFS Estimate
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        42.8
        upper Limit
        62.3
        value
        53.1
    title
    5-year EFS Estimate
denoms
  1. counts
    1. group Id
      OG000
      value
      106
    units
    Participants
description
Overall estimation of the EFS of dasatinib plus chemotherapy was performed utilizing the Kaplan-Meier (KM) Product Limit method. The 3-year and 5-year EFS rates were computed with the corresponding 95% CI's using Greenwood's formula. Analyses of EFS included KM plots with number of patients at risk. Participants who neither relapse nor die or who are lost to follow-up were censored on the date of their last bone marrow, CSF assessment or physical exam, whichever occurred last.
dispersion Type
95% Confidence Interval
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
reporting Status
POSTED
time Frame
From first dose to 3 years or 5 years following first dose
title
Event-Free Survival (EFS) Rate (Kaplan-Meier Estimates)
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice