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NCT00381680 · OUTCOME

Adjusted Event Free Survival

Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia · Source last updated 2024-03-26

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

Measure
NUMBER
Unit
adjusted percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
3 years

What was measured

Adjusted percentage of patients who were event free at 3 years. For patients who received matched donor SCT, EFS was adjusted to start from the actual SCT date. For patients who did not undergo SCT, EFS was adjusted to start from median time to SCT based on patients who received matched related SCT (where patients who had events prior to SCT date were excluded from the calculation of median time to SCT).

Analysis population: The analysis is limited to eligible patients on Standard VCR dosing who received matched related SCT, excluding patients who had events prior to receiving SCT. And those patients on Regimen A who did not undergo SCT, excluding patients who went off therapy prior to the adjusted starting time.

Groups in this outcome

Regimen A: Standard Vincristine Dosing

Standard VCR dosing (1.5 mg/m\^2, max 2 mg)

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

Analysis denominator · Participants

GroupSource count
Regimen A: Standard Vincristine Dosing152

Reported measurements

Received SCT

Analysis denominator · Participants

GroupSource count
Regimen A: Standard Vincristine Dosing34
Values in adjusted percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Regimen A: Standard Vincristine Dosing82.2Not reported68.895.5Not reported
Did not receive SCT

Analysis denominator · Participants

GroupSource count
Regimen A: Standard Vincristine Dosing118
Values in adjusted percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Regimen A: Standard Vincristine Dosing64.2Not reported55.373.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        68.8
        upper Limit
        95.5
        value
        82.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        34
      units
      Participants
    title
    Received SCT
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        55.3
        upper Limit
        73.1
        value
        64.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        118
      units
      Participants
    title
    Did not receive SCT
denoms
  1. counts
    1. group Id
      OG000
      value
      152
    units
    Participants
description
Adjusted percentage of patients who were event free at 3 years. For patients who received matched donor SCT, EFS was adjusted to start from the actual SCT date. For patients who did not undergo SCT, EFS was adjusted to start from median time to SCT based on patients who received matched related SCT (where patients who had events prior to SCT date were excluded from the calculation of median time to SCT).
dispersion Type
95% Confidence Interval
groups
  1. description
    Standard VCR dosing (1.5 mg/m\^2, max 2 mg)
    id
    OG000
    title
    Regimen A: Standard Vincristine Dosing
param Type
NUMBER
population Description
The analysis is limited to eligible patients on Standard VCR dosing who received matched related SCT, excluding patients who had events prior to receiving SCT. And those patients on Regimen A who did not undergo SCT, excluding patients who went off therapy prior to the adjusted starting time.
reporting Status
POSTED
time Frame
3 years
title
Adjusted Event Free Survival
type
SECONDARY
unit Of Measure
adjusted percentage of participants

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

Preserved source evidence · Not medical advice