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NCT01459653 · OUTCOME

Modeling Grade 4 CIN 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 added as statistical analyses appendices. CI: confidence interval; CIN: chemotherapy-induced neutropenia; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score

Analysis population: Number of cycles in evaluable sample with any grade 4 CIN 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
EP20061078

Analysis denominator · cycles

GroupSource count
EP20065514

Reported measurements

Source class 1
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006294Not 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
    0.365
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.812
    group Description
    GIS (1 vs. 0) as cycle-level predictor for CIN grade 4 episode
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.003
    param Type
    Odds Ratio (OR)
    param Value
    0.544
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  2. ci Lower Limit
    3.242
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    7.092
    group Description
    Concomitant antibiotic prophylaxis as cycle-level predictor for CIN grade 4 episode
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    4.795
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  3. ci Lower Limit
    3.242
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    7.092
    group Description
    CIN1/4 in previous cycle as cycle-level predictor for CIN grade 4 episode
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    4.083
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  4. ci Lower Limit
    1.542
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.925
    group Description
    History of CIN Grade 4 at enrollment as patient-level predictor for CIN grade 4 episode
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    2.460
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  5. ci Lower Limit
    0.267
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.766
    group Description
    Over- vs. correctly prophylacted as patient-level predictor for CIN grade 4 episode
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.003
    param Type
    Odds Ratio (OR)
    param Value
    0.452
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.365
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.812
    group Description
    GIS (1 vs. 0) as cycle-level predictor for CIN grade 4 episode
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.003
    param Type
    Odds Ratio (OR)
    param Value
    0.544
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  2. ci Lower Limit
    3.242
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    7.092
    group Description
    Concomitant antibiotic prophylaxis as cycle-level predictor for CIN grade 4 episode
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    4.795
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  3. ci Lower Limit
    3.242
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    7.092
    group Description
    CIN1/4 in previous cycle as cycle-level predictor for CIN grade 4 episode
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    4.083
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  4. ci Lower Limit
    1.542
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    3.925
    group Description
    History of CIN Grade 4 at enrollment as patient-level predictor for CIN grade 4 episode
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    2.460
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  5. ci Lower Limit
    0.267
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.766
    group Description
    Over- vs. correctly prophylacted as patient-level predictor for CIN grade 4 episode
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.003
    param Type
    Odds Ratio (OR)
    param Value
    0.452
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        294
denom Units Selected
Participants
denoms
  1. counts
    1. group Id
      OG000
      value
      1078
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      5514
    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 added as statistical analyses appendices. CI: confidence interval; CIN: chemotherapy-induced neutropenia; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score
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 in evaluable sample with any grade 4 CIN 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 Grade 4 CIN Episode: Cycle Level
type
SECONDARY
type Units Analyzed
cycles
unit Of Measure
cycles

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