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NCT01459653 · OUTCOME

Modeling FN Episode: 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 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006. Only results with a p-value of \<0.05 are shown in the statistical appendices. CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia; ECOG: Eastern Cooperative Oncology Group

Analysis population: Number of cycles of patients in evaluable sample with FN episode data

Groups in this outcome

EP2006

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
EP20061273

Analysis denominator · cycles

GroupSource count
EP20066362

Reported measurements

Source class 1
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006105Not 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
    1.284
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.179
    group Description
    ECOG score (per 1 point) as cycle-level predictor for FN episode
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    1.673
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  2. ci Lower Limit
    2.777
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    7.968
    group Description
    Concomitant antibiotic prophylaxis as cycle-level predictor for FN episode
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    4.704
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  3. ci Lower Limit
    1.342
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.574
    group Description
    CIN1/4 in previous cycle as cycle-level predictor for FN episode
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.002
    param Type
    Odds Ratio (OR)
    param Value
    2.190
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  4. ci Lower Limit
    0.067
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.687
    group Description
    History of anaemia at enrollment as patient-level predictor for FN episode
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.010
    param Type
    Odds Ratio (OR)
    param Value
    0.215
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  5. ci Lower Limit
    1.169
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    10.487
    group Description
    Under- vs. over-prophylacted as patient-level predictor for FN episode
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.025
    param Type
    Odds Ratio (OR)
    param Value
    3.501
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    1.284
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.179
    group Description
    ECOG score (per 1 point) as cycle-level predictor for FN episode
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    1.673
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  2. ci Lower Limit
    2.777
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    7.968
    group Description
    Concomitant antibiotic prophylaxis as cycle-level predictor for FN episode
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    4.704
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  3. ci Lower Limit
    1.342
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.574
    group Description
    CIN1/4 in previous cycle as cycle-level predictor for FN episode
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.002
    param Type
    Odds Ratio (OR)
    param Value
    2.190
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  4. ci Lower Limit
    0.067
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.687
    group Description
    History of anaemia at enrollment as patient-level predictor for FN episode
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.010
    param Type
    Odds Ratio (OR)
    param Value
    0.215
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  5. ci Lower Limit
    1.169
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    10.487
    group Description
    Under- vs. over-prophylacted as patient-level predictor for FN episode
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.025
    param Type
    Odds Ratio (OR)
    param Value
    3.501
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        105
denom Units Selected
Participants
denoms
  1. counts
    1. group Id
      OG000
      value
      1273
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      6362
    units
    cycles
description
Objective 8: To model patient- and center-level variables between patients who responded and those who did not respond to primary or secondary prophylaxis with EP2006. Objective 9: To model patient- and center-level variables between patients who had chemotherapy dose delays or reductions, surgery delays and cancellations, and radiotherapy delays, dose reductions, or cancellations vs. no such events during the course of primary or secondary prophylaxis with EP2006. Only results with a p-value of \<0.05 are shown in the statistical appendices. CI: confidence interval; CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia; ECOG: Eastern Cooperative Oncology Group
groups
  1. description
    Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
    id
    OG000
    title
    EP2006
param Type
NUMBER
population Description
Number of cycles of patients in evaluable sample with FN episode data
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
Modeling FN Episode: Cycle Level
type
SECONDARY
type Units Analyzed
cycles
unit Of Measure
cycles

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