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NCT00549848 · OUTCOME

Probability of Overall Survival

Total Therapy Study XVI for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia · Source last updated 2022-08-23

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
For Total XVI: 3.5 years after the last enrollment, up to approximately 13.5 years For Total XV: patients are followed continuously, up to 20.5 years

What was measured

To estimate the overall survival of children with ALL who are treated with risk-directed therapy and to compare the EFS results of TOTXVI with that of TOTXV.

Analysis population: All eligible patients entered on TOTXVI will be included in these analyses, as appropriate. Infants will be excluded from the Total XVI for comparisons with TOTXV as only children at least one year of age at diagnosis were treated on Total XV.

Groups in this outcome

TOTXVI PEG 3500

Patients randomized on the first day of continuation phase to receive 3500 units/m\^2 dose of PEG-asparaginase

TOTXVI PEG 2500

Patients randomized on the first day of continuation phase to receive 2,500 units/m\^2 dose of PEG-asparaginase

TOTVI Not Randomized

Patients who came off study prior to randomization

All Eligible Patients in TOTXV

All eligible children with ALL who are treated with risk-directed therapy.

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

Analysis denominator · Participants

GroupSource count
TOTXVI PEG 3500201
TOTXVI PEG 2500205
TOTVI Not Randomized180
All Eligible Patients in TOTXV498

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
TOTXVI PEG 350097.5Not reported95.399.7Not reported
TOTXVI PEG 250095.6Not reported92.798.5Not reported
TOTVI Not Randomized90.8Not reported84.796.9Not reported
All Eligible Patients in TOTXV93.5Not reported91.395.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        95.3
        upper Limit
        99.7
        value
        97.5
      2. group Id
        OG001
        lower Limit
        92.7
        upper Limit
        98.5
        value
        95.6
      3. group Id
        OG002
        lower Limit
        84.7
        upper Limit
        96.9
        value
        90.8
      4. group Id
        OG003
        lower Limit
        91.3
        upper Limit
        95.7
        value
        93.5
denoms
  1. counts
    1. group Id
      OG000
      value
      201
    2. group Id
      OG001
      value
      205
    3. group Id
      OG002
      value
      180
    4. group Id
      OG003
      value
      498
    units
    Participants
description
To estimate the overall survival of children with ALL who are treated with risk-directed therapy and to compare the EFS results of TOTXVI with that of TOTXV.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients randomized on the first day of continuation phase to receive 3500 units/m\^2 dose of PEG-asparaginase
    id
    OG000
    title
    TOTXVI PEG 3500
  2. description
    Patients randomized on the first day of continuation phase to receive 2,500 units/m\^2 dose of PEG-asparaginase
    id
    OG001
    title
    TOTXVI PEG 2500
  3. description
    Patients who came off study prior to randomization
    id
    OG002
    title
    TOTVI Not Randomized
  4. description
    All eligible children with ALL who are treated with risk-directed therapy.
    id
    OG003
    title
    All Eligible Patients in TOTXV
param Type
NUMBER
population Description
All eligible patients entered on TOTXVI will be included in these analyses, as appropriate. Infants will be excluded from the Total XVI for comparisons with TOTXV as only children at least one year of age at diagnosis were treated on Total XV.
reporting Status
POSTED
time Frame
For Total XVI: 3.5 years after the last enrollment, up to approximately 13.5 years For Total XV: patients are followed continuously, up to 20.5 years
title
Probability of Overall Survival
type
SECONDARY
unit Of Measure
Percentage of participants

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Preserved source evidence · Not medical advice