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NCT01459653 · OUTCOME

Modeling CIN/FN-related Chemotherapy Disturbance: 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; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score; Chemotherapy disturbance=dose reduction, delay, and/or cancellation

Analysis population: Cycles of patients in evaluable sample with CIN/FN-related chemotherapy disturbance with 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
EP20061045

Analysis denominator · cycles

GroupSource count
EP20063376

Reported measurements

Source class 1
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006174Not 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
    5.426
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    14.699
    group Description
    CIN1/4 in previous cycle as cycle-level predictor for CIN/FN-related chemotherapy disturbance
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    8.931
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  2. ci Lower Limit
    0.152
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.740
    group Description
    Hematological cancer (vs. oncologic) as patient-level predictor for CIN/FN-related chemotherapy disturbance
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.007
    param Type
    Odds Ratio (OR)
    param Value
    0.336
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  3. ci Lower Limit
    0.999
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.000
    group Description
    Cancer patients seen in 2009 (per 1 patient) as center-level predictor for CIN/FN-related chemotherapy disturbance
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.006
    param Type
    Odds Ratio (OR)
    param Value
    0.999
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  4. ci Lower Limit
    1.000
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.001
    group Description
    Chemotherapy-treated cancer patients in 2009 (per 1 patient) as center-level predictor for CIN/FN-related chemotherapy disturbance
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    1.001
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  5. ci Lower Limit
    1.127
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.353
    group Description
    Center type: academic vs non-academic as center-level predictor for CIN/FN-related chemotherapy disturbance
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.024
    param Type
    Odds Ratio (OR)
    param Value
    2.456
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  6. ci Lower Limit
    1.342
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    8.331
    group Description
    Center type: academic-affiliated vs non-academic as center-level predictor for CIN/FN-related chemotherapy disturbance
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.010
    param Type
    Odds Ratio (OR)
    param Value
    3.344
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    5.426
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    14.699
    group Description
    CIN1/4 in previous cycle as cycle-level predictor for CIN/FN-related chemotherapy disturbance
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    8.931
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  2. ci Lower Limit
    0.152
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.740
    group Description
    Hematological cancer (vs. oncologic) as patient-level predictor for CIN/FN-related chemotherapy disturbance
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.007
    param Type
    Odds Ratio (OR)
    param Value
    0.336
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  3. ci Lower Limit
    0.999
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.000
    group Description
    Cancer patients seen in 2009 (per 1 patient) as center-level predictor for CIN/FN-related chemotherapy disturbance
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.006
    param Type
    Odds Ratio (OR)
    param Value
    0.999
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  4. ci Lower Limit
    1.000
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.001
    group Description
    Chemotherapy-treated cancer patients in 2009 (per 1 patient) as center-level predictor for CIN/FN-related chemotherapy disturbance
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    1.001
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  5. ci Lower Limit
    1.127
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.353
    group Description
    Center type: academic vs non-academic as center-level predictor for CIN/FN-related chemotherapy disturbance
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.024
    param Type
    Odds Ratio (OR)
    param Value
    2.456
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  6. ci Lower Limit
    1.342
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    8.331
    group Description
    Center type: academic-affiliated vs non-academic as center-level predictor for CIN/FN-related chemotherapy disturbance
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.010
    param Type
    Odds Ratio (OR)
    param Value
    3.344
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        174
denom Units Selected
Participants
denoms
  1. counts
    1. group Id
      OG000
      value
      1045
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      3376
    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; GCSF: granulocyte colony-stimulating factor; GIS: GCSF Initiation Score; Chemotherapy disturbance=dose reduction, delay, and/or cancellation
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
Cycles of patients in evaluable sample with CIN/FN-related chemotherapy disturbance with 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 CIN/FN-related Chemotherapy Disturbance: Cycle Level
type
SECONDARY
type Units Analyzed
cycles
unit Of Measure
cycles

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Preserved source evidence · Not medical advice