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NCT01459653 · OUTCOME

EP2006 Day of Initiation by Prophylaxis Type: Cycle Level

Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor · Source last updated 2016-01-11

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

Measure
MEAN
Unit
days
Interval / dispersion
Standard Deviation
Time frame
All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days

What was measured

Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.

Groups in this outcome

EP2006: Primary Prophylaxis

Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary prophylaxis for FN.

EP2006: Secondary Prophylaxis

Cancer patients treated with chemotherapy as and who are prescribed commercially available filgrastim biosimilar for secondary prophylaxis for FN.

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

Analysis denominator · Participants

GroupSource count
EP2006: Primary Prophylaxis1033
EP2006: Secondary Prophylaxis390

Analysis denominator · cycles

GroupSource count
EP2006: Primary Prophylaxis4700
EP2006: Secondary Prophylaxis1230

Reported measurements

Source class 1
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
EP2006: Primary Prophylaxis3.23.0Not reportedNot reportedNot reported
EP2006: Secondary Prophylaxis2.62.9Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    -0.4832
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -0.0646
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0103
    param Type
    Slope
    param Value
    -0.2739
    statistical Comment
    degrees of freedom: 4507
    statistical Method
    ANOVA
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    -0.4832
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -0.0646
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0103
    param Type
    Slope
    param Value
    -0.2739
    statistical Comment
    degrees of freedom: 4507
    statistical Method
    ANOVA
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.0
        value
        3.2
      2. group Id
        OG001
        spread
        2.9
        value
        2.6
denom Units Selected
Participants
denoms
  1. counts
    1. group Id
      OG000
      value
      1033
    2. group Id
      OG001
      value
      390
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      4700
    2. group Id
      OG001
      value
      1230
    units
    cycles
description
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
dispersion Type
Standard Deviation
groups
  1. description
    Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary prophylaxis for FN.
    id
    OG000
    title
    EP2006: Primary Prophylaxis
  2. description
    Cancer patients treated with chemotherapy as and who are prescribed commercially available filgrastim biosimilar for secondary prophylaxis for FN.
    id
    OG001
    title
    EP2006: Secondary Prophylaxis
param Type
MEAN
reporting Status
POSTED
time Frame
All cycles. Patients were evaluated at the enrollment cycle and then re-evaluated at each cycle for a maximum total of 6 cycles; however, the scheduling of these evaluations was left to the discretion of the physician, mean duration of study for 105 days
title
EP2006 Day of Initiation by Prophylaxis Type: Cycle Level
type
PRIMARY
type Units Analyzed
cycles
unit Of Measure
days

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Preserved source evidence · Not medical advice