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NCT00137111 · OUTCOME

Minimal Residual Disease (MRD)

Therapy for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia · Source last updated 2020-09-11

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
End of Induction (Day 46 MRD measurement)

What was measured

Detection of MRD at end of induction where positive MRD was defined as one or more leukemic cell per 10,000 mononuclear bone-marrow cells (\>=0.01%).

Analysis population: Patients who completed induction and had successful MRD studies on day 46.

Groups in this outcome

Total Therapy

Total therapy applies to all eligible patients.

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

Analysis denominator · Participants

GroupSource count
Total Therapy492

Reported measurements

Negative <0.01%
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Total Therapy390Not reportedNot reportedNot reportedNot reported
Positive >= 0.01%
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Total Therapy102Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    75.69
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    82.85
    group Description
    Of the 498 eligible patients, 492 were successfully evaluated with day 46 MRD measurement.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Binomial proportion
    param Value
    79.27
    statistical Method
    Binomial proportion
Complete source fields
analyses
  1. ci Lower Limit
    75.69
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    82.85
    group Description
    Of the 498 eligible patients, 492 were successfully evaluated with day 46 MRD measurement.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    Binomial proportion
    param Value
    79.27
    statistical Method
    Binomial proportion
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        390
    title
    Negative <0.01%
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        102
    title
    Positive >= 0.01%
denoms
  1. counts
    1. group Id
      OG000
      value
      492
    units
    Participants
description
Detection of MRD at end of induction where positive MRD was defined as one or more leukemic cell per 10,000 mononuclear bone-marrow cells (\>=0.01%).
groups
  1. description
    Total therapy applies to all eligible patients.
    id
    OG000
    title
    Total Therapy
param Type
NUMBER
population Description
Patients who completed induction and had successful MRD studies on day 46.
reporting Status
POSTED
time Frame
End of Induction (Day 46 MRD measurement)
title
Minimal Residual Disease (MRD)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice