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NCT01459653 · OUTCOME

EP2006 Dose by Chemotherapy Toxicity: 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.

Groups in this outcome

EP2006: Risk <10%

Cancer patients with chemotherapy toxicity \<10% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.

EP2006: Risk 10-20%

Cancer patients with chemotherapy toxicity 10-20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.

EP2006: Risk >20%

Cancer patients with chemotherapy toxicity \>20% 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: Risk <10%151
EP2006: Risk 10-20%647
EP2006: Risk >20%631

Analysis denominator · cycles

GroupSource count
EP2006: Risk <10%546
EP2006: Risk 10-20%2534
EP2006: Risk >20%2843

Reported measurements

30 MIU/day
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006: Risk <10%357Not reportedNot reportedNot reportedNot reported
EP2006: Risk 10-20%1375Not reportedNot reportedNot reportedNot reported
EP2006: Risk >20%1441Not reportedNot reportedNot reportedNot reported
48 MIU/day
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006: Risk <10%189Not reportedNot reportedNot reportedNot reported
EP2006: Risk 10-20%1159Not reportedNot reportedNot reportedNot reported
EP2006: Risk >20%1402Not 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
    1.0680
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.5061
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0067
    param Type
    Odds Ratio (OR)
    param Value
    1.2683
    statistical Method
    Chi-squared
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    1.0680
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.5061
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0067
    param Type
    Odds Ratio (OR)
    param Value
    1.2683
    statistical Method
    Chi-squared
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        357
      2. group Id
        OG001
        value
        1375
      3. group Id
        OG002
        value
        1441
    title
    30 MIU/day
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        189
      2. group Id
        OG001
        value
        1159
      3. group Id
        OG002
        value
        1402
    title
    48 MIU/day
denom Units Selected
Participants
denoms
  1. counts
    1. group Id
      OG000
      value
      151
    2. group Id
      OG001
      value
      647
    3. group Id
      OG002
      value
      631
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      546
    2. group Id
      OG001
      value
      2534
    3. group Id
      OG002
      value
      2843
    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 with chemotherapy toxicity \<10% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
    id
    OG000
    title
    EP2006: Risk <10%
  2. description
    Cancer patients with chemotherapy toxicity 10-20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
    id
    OG001
    title
    EP2006: Risk 10-20%
  3. description
    Cancer patients with chemotherapy toxicity \>20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
    id
    OG002
    title
    EP2006: Risk >20%
param Type
NUMBER
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 Chemotherapy Toxicity: Cycle Level
type
PRIMARY
type Units Analyzed
cycles
unit Of Measure
cycles

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Preserved source evidence · Not medical advice