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NCT01459653 · OUTCOME

EP2006 Duration 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
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: <10% Risk

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

EP2006: 10-20% Risk

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

EP2006: >20% Risk

Cancer patients treated with chemotherapy with high toxicity (\>20% risk) 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: <10% Risk150
EP2006: 10-20% Risk638
EP2006: >20% Risk635

Analysis denominator · cycles

GroupSource count
EP2006: <10% Risk541
EP2006: 10-20% Risk2513
EP2006: >20% Risk2875

Reported measurements

Source class 1
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
EP2006: <10% Risk4.62.4Not reportedNot reportedNot reported
EP2006: 10-20% Risk5.02.2Not reportedNot reportedNot reported
EP2006: >20% Risk5.32.4Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    -0.0452
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.1029
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Slope
    param Value
    0.0741
    statistical Comment
    degrees of freedom: 4505
    statistical Method
    ANOVA
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    -0.0452
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.1029
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Slope
    param Value
    0.0741
    statistical Comment
    degrees of freedom: 4505
    statistical Method
    ANOVA
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.4
        value
        4.6
      2. group Id
        OG001
        spread
        2.2
        value
        5.0
      3. group Id
        OG002
        spread
        2.4
        value
        5.3
denom Units Selected
Participants
denoms
  1. counts
    1. group Id
      OG000
      value
      150
    2. group Id
      OG001
      value
      638
    3. group Id
      OG002
      value
      635
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      541
    2. group Id
      OG001
      value
      2513
    3. group Id
      OG002
      value
      2875
    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 with low toxicity (\<10% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
    id
    OG000
    title
    EP2006: <10% Risk
  2. description
    Cancer patients treated with chemotherapy with medium toxicity (10-20% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
    id
    OG001
    title
    EP2006: 10-20% Risk
  3. description
    Cancer patients treated with chemotherapy with high toxicity (\>20% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
    id
    OG002
    title
    EP2006: >20% Risk
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 Duration by Chemotherapy Toxicity: Cycle Level
type
PRIMARY
type Units Analyzed
cycles
unit Of Measure
days

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Preserved source evidence · Not medical advice