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NCT01459653 · OUTCOME

Type of EP 2006 Prophylaxis by Age Group

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
NUMBER
Unit
participants
Interval / dispersion
Not reported
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.

Analysis population: Evaluable sample by age

Groups in this outcome

EP2006: <65 Years

Cancer patients \<65 years treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.

EP2006: >=65 Years

Cancer patients \>=65 years treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or 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: <65 Years849
EP2006: >=65 Years598

Reported measurements

Primary (initiated in cycle1)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006: <65 Years626Not reportedNot reportedNot reportedNot reported
EP2006: >=65 Years420Not reportedNot reportedNot reportedNot reported
Secondary, initiated in cycle2 or later
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006: <65 Years223Not reportedNot reportedNot reportedNot reported
EP2006: >=65 Years178Not 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
    0.9428
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.5012
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.1432
    param Type
    Odds Ratio (OR)
    param Value
    1.1897
    statistical Method
    Chi-squared
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.9428
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.5012
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.1432
    param Type
    Odds Ratio (OR)
    param Value
    1.1897
    statistical Method
    Chi-squared
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        626
      2. group Id
        OG001
        value
        420
    title
    Primary (initiated in cycle1)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        223
      2. group Id
        OG001
        value
        178
    title
    Secondary, initiated in cycle2 or later
denoms
  1. counts
    1. group Id
      OG000
      value
      849
    2. group Id
      OG001
      value
      598
    units
    Participants
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.
groups
  1. description
    Cancer patients \<65 years treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
    id
    OG000
    title
    EP2006: <65 Years
  2. description
    Cancer patients \>=65 years treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
    id
    OG001
    title
    EP2006: >=65 Years
param Type
NUMBER
population Description
Evaluable sample by age
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
Type of EP 2006 Prophylaxis by Age Group
type
PRIMARY
unit Of Measure
participants

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Preserved source evidence · Not medical advice