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NCT01987596 · OUTCOME

Cumulative GCSF Dose

Study of Fixed vs. Flexible Filgrastim to Accelerate Bone Marrow Recovery After Chemotherapy in Children With Cancer · Source last updated 2020-10-29

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

Measure
MEAN
Unit
Doses
Interval / dispersion
95% Confidence Interval
Time frame
up until engraftment

What was measured

Cumulative GCSF dose - number of GCSF injections until ANC recovery greater than or equal to 1,000/uL from the start of chemotherapy

Analysis population: Patients who had data for period 2

Groups in this outcome

Fixed Filgrastim

Patients receive filgrastim daily SC QD started at 24 hours after completion of chemotherapy and stopped when ANC reaches at least 1,000/uL post nadir.

Flexible Filgrastim

Patients receive filgrastim SC QD started on the first day after chemotherapy and on any day ANC falls below 1,000/uL and stopped when ANC reaches at least 1,000/uL post nadir.

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

Analysis denominator · Participants

GroupSource count
Fixed Filgrastim19
Flexible Filgrastim19

Reported measurements

Source class 1
Values in Doses · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Fixed Filgrastim10.5Not reported9.611.2Not reported
Flexible Filgrastim6.7Not reported5.57.9Not reported

Source statistical analyses

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

  1. group Description
    two-period crossover design analysis
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    statistical Method
    ANOVA
Complete source fields
analyses
  1. group Description
    two-period crossover design analysis
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    statistical Method
    ANOVA
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.6
        upper Limit
        11.2
        value
        10.5
      2. group Id
        OG001
        lower Limit
        5.5
        upper Limit
        7.9
        value
        6.7
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    2. group Id
      OG001
      value
      19
    units
    Participants
description
Cumulative GCSF dose - number of GCSF injections until ANC recovery greater than or equal to 1,000/uL from the start of chemotherapy
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive filgrastim daily SC QD started at 24 hours after completion of chemotherapy and stopped when ANC reaches at least 1,000/uL post nadir.
    id
    OG000
    title
    Fixed Filgrastim
  2. description
    Patients receive filgrastim SC QD started on the first day after chemotherapy and on any day ANC falls below 1,000/uL and stopped when ANC reaches at least 1,000/uL post nadir.
    id
    OG001
    title
    Flexible Filgrastim
param Type
MEAN
population Description
Patients who had data for period 2
reporting Status
POSTED
time Frame
up until engraftment
title
Cumulative GCSF Dose
type
SECONDARY
unit Of Measure
Doses

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice