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NCT01459653 · OUTCOME

Type of EP2006 Prophylaxis by Gender

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 gender

Groups in this outcome

EP2006: Male

Male cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.

EP2006: Female

Female cancer patients 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: Male561
EP2006: Female886

Reported measurements

Primary (initiated in cycle1)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006: Male397Not reportedNot reportedNot reportedNot reported
EP2006: Female649Not reportedNot reportedNot reportedNot reported
Secondary (initiated in cycle2 or later)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006: Male164Not reportedNot reportedNot reportedNot reported
EP2006: Female237Not 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
    0.6989
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.1182
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.3038
    param Type
    Odds Ratio (OR)
    param Value
    0.8840
    statistical Method
    Chi-squared
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.6989
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.1182
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.3038
    param Type
    Odds Ratio (OR)
    param Value
    0.8840
    statistical Method
    Chi-squared
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        397
      2. group Id
        OG001
        value
        649
    title
    Primary (initiated in cycle1)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        164
      2. group Id
        OG001
        value
        237
    title
    Secondary (initiated in cycle2 or later)
denoms
  1. counts
    1. group Id
      OG000
      value
      561
    2. group Id
      OG001
      value
      886
    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
    Male cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
    id
    OG000
    title
    EP2006: Male
  2. description
    Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
    id
    OG001
    title
    EP2006: Female
param Type
NUMBER
population Description
Evaluable sample by gender
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 EP2006 Prophylaxis by Gender
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice