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NCT00557193 · OUTCOME

Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2)

Combination Chemotherapy With or Without Lestaurtinib in Treating Younger Patients With Newly Diagnosed Acute Lymphoblastic Leukemia · Source last updated 2024-07-15

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage probability
Interval / dispersion
90% Confidence Interval
Time frame
From start of post-induction therapy for up to 10 years

What was measured

EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto.

Analysis population: All 67 patients on Arm C (Safety and Efficacy at Dose Level 2) were included in the analysis.

Groups in this outcome

Arm C (Safety/Efficacy Dose Level 2)

Arm C (Safety and Efficacy), IR/HR MLL-R chemotherapy and lestaurtinib at DL2 (HR: 4.25 mg/kg/day; SR: 5 mg/kg/day)

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm C (Safety/Efficacy Dose Level 2)67

Reported measurements

Source class 1
Values in percentage probability · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm C (Safety/Efficacy Dose Level 2)35.82Not reported25.9845.66Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        25.98
        upper Limit
        45.66
        value
        35.82
denoms
  1. counts
    1. group Id
      OG000
      value
      67
    units
    Participants
description
EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto.
dispersion Type
90% Confidence Interval
groups
  1. description
    Arm C (Safety and Efficacy), IR/HR MLL-R chemotherapy and lestaurtinib at DL2 (HR: 4.25 mg/kg/day; SR: 5 mg/kg/day)
    id
    OG000
    title
    Arm C (Safety/Efficacy Dose Level 2)
param Type
NUMBER
population Description
All 67 patients on Arm C (Safety and Efficacy at Dose Level 2) were included in the analysis.
reporting Status
POSTED
time Frame
From start of post-induction therapy for up to 10 years
title
Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2)
type
PRIMARY
unit Of Measure
percentage probability

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

Preserved source evidence · Not medical advice