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NCT01987596 · OUTCOME

Days to First G-CSF 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
days
Interval / dispersion
95% Confidence Interval
Time frame
time to ANC 1000

What was measured

Time (in days) to first G-CSF dose

Analysis population: All participants with period 2 data

Groups in this outcome

Arm I (Fixed Filgrastim)

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

Arm II (Flexible Filgrastim)

Patients receive filgrastim SC QD started on the first day after chemotherapy when 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
Arm I (Fixed Filgrastim)19
Arm II (Flexible Filgrastim)19

Reported measurements

Source class 1
Values in days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Fixed Filgrastim)5.1Not reported4.55.7Not reported
Arm II (Flexible Filgrastim)9.5Not reported8.410.5Not reported

Source statistical analyses

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

  1. group Description
    2 treatment, 2 periiod cross-over 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
    2 treatment, 2 periiod cross-over 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
        4.5
        upper Limit
        5.7
        value
        5.1
      2. group Id
        OG001
        lower Limit
        8.4
        upper Limit
        10.5
        value
        9.5
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    2. group Id
      OG001
      value
      19
    units
    Participants
description
Time (in days) to first G-CSF dose
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive filgrastim SC QD started at 24 hours after completion of chemotherapy and continued daily until ANC reaches at least 1,000/uL post nadir.
    id
    OG000
    title
    Arm I (Fixed Filgrastim)
  2. description
    Patients receive filgrastim SC QD started on the first day after chemotherapy when ANC falls below 1,000/uL and stopped when ANC reaches at least 1,000/uL post nadir.
    id
    OG001
    title
    Arm II (Flexible Filgrastim)
param Type
MEAN
population Description
All participants with period 2 data
reporting Status
POSTED
time Frame
time to ANC 1000
title
Days to First G-CSF Dose
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice