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NCT01459653 · OUTCOME

Predictors of Absolute Neutrophil Count

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
participants
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 6: To examine the multilevel determinants (patient, center) of hematological outcomes of primary and secondary prophylaxis with EP2006 to better understand the variability in outcomes achieved. Hierarchical modeling was used to test the relationship of patient- and physician/center-level variables and treatment response in terms of ANC. This analysis was conducted at the cycle level using a 1-cycle lag between treatment patterns and outcomes, that is study drug treatment patterns in one cycle predicted the ANC value at the beginning of the next cycle. Log-transformed ANC values were used. Table presents predictors for ANC: GCSF decision, study drug dose, tumor type, patient gender, ECOG, Hb Since log-transformed Absolute Neutrophil Count (ANC) values were used, Exp(beta) can be interpreted in terms of % change in ANC for each unit change in predictor or for each category relative to the referent (for categorical variables); Hb=Hemoglobin

Analysis population: Cycles for patients in evaluable sample 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
EP20061185

Analysis denominator · cycles

GroupSource count
EP20064333

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP20061185Not 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
    0.84
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.01
    group Description
    GCSF treatment decision (under vs correct) as predictor for ANC
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0683
    param Type
    Slope
    param Value
    0.92
    statistical Comment
    degrees of freedom: 3181
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  2. ci Lower Limit
    0.82
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.96
    group Description
    GCSF decision (Over vs correct) as predictor for ANC
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0019
    param Type
    Slope
    param Value
    0.89
    statistical Comment
    degrees of freedom: 3181
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  3. ci Lower Limit
    0.94
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.15
    group Description
    GCSF decision (Under vs over) as predictor for ANC
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.4469
    param Type
    Slope
    param Value
    1.04
    statistical Comment
    degrees of freedom: 3181
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  4. ci Lower Limit
    1.03
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.19
    group Description
    Study drug dose (higher vs lower) as predictor for ANC
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0079
    param Type
    Slope
    param Value
    1.11
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  5. ci Lower Limit
    0.72
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.91
    group Description
    Tumor type (hematological vs solid) as predictor for ANC
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0004
    param Type
    Slope
    param Value
    0.81
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  6. ci Lower Limit
    0.80
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.92
    group Description
    Patient gender (female vs male) as predictor for ANC
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Slope
    param Value
    0.86
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  7. ci Lower Limit
    1.01
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.08
    group Description
    ECOG (per 1 point) as predictor for ANC
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0235
    param Type
    Slope
    param Value
    1.04
    statistical Method
    Regression, Linear
    tested Non Inferiority
    false
  8. ci Lower Limit
    1.02
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.05
    group Description
    Hb (per g/dL) as predictor for ANC
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Slope
    param Value
    1.03
    statistical Method
    Regression, Linear
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.84
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.01
    group Description
    GCSF treatment decision (under vs correct) as predictor for ANC
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0683
    param Type
    Slope
    param Value
    0.92
    statistical Comment
    degrees of freedom: 3181
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  2. ci Lower Limit
    0.82
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.96
    group Description
    GCSF decision (Over vs correct) as predictor for ANC
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0019
    param Type
    Slope
    param Value
    0.89
    statistical Comment
    degrees of freedom: 3181
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  3. ci Lower Limit
    0.94
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.15
    group Description
    GCSF decision (Under vs over) as predictor for ANC
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.4469
    param Type
    Slope
    param Value
    1.04
    statistical Comment
    degrees of freedom: 3181
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  4. ci Lower Limit
    1.03
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.19
    group Description
    Study drug dose (higher vs lower) as predictor for ANC
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0079
    param Type
    Slope
    param Value
    1.11
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  5. ci Lower Limit
    0.72
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.91
    group Description
    Tumor type (hematological vs solid) as predictor for ANC
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0004
    param Type
    Slope
    param Value
    0.81
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  6. ci Lower Limit
    0.80
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.92
    group Description
    Patient gender (female vs male) as predictor for ANC
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Slope
    param Value
    0.86
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  7. ci Lower Limit
    1.01
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.08
    group Description
    ECOG (per 1 point) as predictor for ANC
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0235
    param Type
    Slope
    param Value
    1.04
    statistical Method
    Regression, Linear
    tested Non Inferiority
    false
  8. ci Lower Limit
    1.02
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.05
    group Description
    Hb (per g/dL) as predictor for ANC
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Slope
    param Value
    1.03
    statistical Method
    Regression, Linear
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1185
denom Units Selected
Participants
denoms
  1. counts
    1. group Id
      OG000
      value
      1185
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      4333
    units
    cycles
description
Objective 6: To examine the multilevel determinants (patient, center) of hematological outcomes of primary and secondary prophylaxis with EP2006 to better understand the variability in outcomes achieved. Hierarchical modeling was used to test the relationship of patient- and physician/center-level variables and treatment response in terms of ANC. This analysis was conducted at the cycle level using a 1-cycle lag between treatment patterns and outcomes, that is study drug treatment patterns in one cycle predicted the ANC value at the beginning of the next cycle. Log-transformed ANC values were used. Table presents predictors for ANC: GCSF decision, study drug dose, tumor type, patient gender, ECOG, Hb Since log-transformed Absolute Neutrophil Count (ANC) values were used, Exp(beta) can be interpreted in terms of % change in ANC for each unit change in predictor or for each category relative to the referent (for categorical variables); Hb=Hemoglobin
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 for patients in evaluable sample 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
Predictors of Absolute Neutrophil Count
type
PRIMARY
type Units Analyzed
cycles
unit Of Measure
participants

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Preserved source evidence · Not medical advice