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NCT01459653 · OUTCOME

EP2006 Dose by Patient Weight: 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
NUMBER
Unit
cycles
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: All cycles treated

Groups in this outcome

EP2006: <=65kg

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

EP2006: >65kg

Cancer patients weighing \>65kg 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: <=65kg568
EP2006: >65kg857

Analysis denominator · cycles

GroupSource count
EP2006: <=65kg2272
EP2006: >65kg3666

Reported measurements

30 MIU/day
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006: <=65kg1501Not reportedNot reportedNot reportedNot reported
EP2006: >65kg1681Not reportedNot reportedNot reportedNot reported
48 MIU/day
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006: <=65kg771Not reportedNot reportedNot reportedNot reported
EP2006: >65kg1985Not 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
    1.8113
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.9177
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Odds Ratio (OR)
    param Value
    2.2989
    statistical Method
    Chi-squared
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    1.8113
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.9177
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Odds Ratio (OR)
    param Value
    2.2989
    statistical Method
    Chi-squared
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1501
      2. group Id
        OG001
        value
        1681
    title
    30 MIU/day
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        771
      2. group Id
        OG001
        value
        1985
    title
    48 MIU/day
denom Units Selected
Participants
denoms
  1. counts
    1. group Id
      OG000
      value
      568
    2. group Id
      OG001
      value
      857
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      2272
    2. group Id
      OG001
      value
      3666
    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.
groups
  1. description
    Cancer patients weighing \<=65kg treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
    id
    OG000
    title
    EP2006: <=65kg
  2. description
    Cancer patients weighing \>65kg treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
    id
    OG001
    title
    EP2006: >65kg
param Type
NUMBER
population Description
All cycles treated
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 Dose by Patient Weight: Cycle Level
type
PRIMARY
type Units Analyzed
cycles
unit Of Measure
cycles

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

Preserved source evidence · Not medical advice