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NCT00137111 · OUTCOME

Circulating Leukemia Cells in Peripheral Blood Change From Prior to the Methotrexate Infusion to Three Days After Between Two Arms (4 Hours vs. 24 Hours)

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
MEAN
Unit
Percent change
Interval / dispersion
Standard Deviation
Time frame
Immediately before the methotrexate infusion and three days after subsequent infusion

What was measured

White blood cell (leukocytes) counts in peripheral blood by Complete Blood Count Measurement: Percentage change of leukemia cells from baseline

Analysis population: Three hundred twenty (320) patients were evaluable to assess the influence of infusion duration on methotrexate's antileukemic effects.

Groups in this outcome

4 hr

4 hour High-Dose Methotrexate Infusion in upfront window treatment

24 hr

24 hour High-Dose Methotrexate Infusion in upfront window treatment

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

Analysis denominator · Participants

GroupSource count
4 hr156
24 hr164

Reported measurements

Source class 1
Values in Percent change · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
4 hr-4442.2Not reportedNot reportedNot reported
24 hr-5035.5Not reportedNot reportedNot reported

Source statistical analyses

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

  1. group Description
    t-test adjusting for lineage and ploidy
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    .15
    p Value Comment
    p-value from t-test after adjusted for lineage and ploidy
    statistical Method
    t-test, 2 sided
Complete source fields
analyses
  1. group Description
    t-test adjusting for lineage and ploidy
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    .15
    p Value Comment
    p-value from t-test after adjusted for lineage and ploidy
    statistical Method
    t-test, 2 sided
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        42.2
        value
        -44
      2. group Id
        OG001
        spread
        35.5
        value
        -50
denoms
  1. counts
    1. group Id
      OG000
      value
      156
    2. group Id
      OG001
      value
      164
    units
    Participants
description
White blood cell (leukocytes) counts in peripheral blood by Complete Blood Count Measurement: Percentage change of leukemia cells from baseline
dispersion Type
Standard Deviation
groups
  1. description
    4 hour High-Dose Methotrexate Infusion in upfront window treatment
    id
    OG000
    title
    4 hr
  2. description
    24 hour High-Dose Methotrexate Infusion in upfront window treatment
    id
    OG001
    title
    24 hr
param Type
MEAN
population Description
Three hundred twenty (320) patients were evaluable to assess the influence of infusion duration on methotrexate's antileukemic effects.
reporting Status
POSTED
time Frame
Immediately before the methotrexate infusion and three days after subsequent infusion
title
Circulating Leukemia Cells in Peripheral Blood Change From Prior to the Methotrexate Infusion to Three Days After Between Two Arms (4 Hours vs. 24 Hours)
type
SECONDARY
unit Of Measure
Percent change

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

Preserved source evidence · Not medical advice