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NCT01459653 · OUTCOME

Patient/Center-level Covariance Parameter Estimates 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. Mean and standard error estimated from ANCOVA

Analysis population: Evaluable sample

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 Num Sides
    TWO_SIDED
    estimate Comment
    The intra-class correlation coefficient (ICC) was computed to quantify the variability in patient outcome attributable to within-center variability before any patient-level determinants are considered.
    group Description
    ANCOVA model was used taking into account center, patient within center-level and within-patient level (over time). This appendix describes the center-level.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0003
    param Type
    Intra-class correlation coefficient
    param Value
    0.09
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
  2. ci Num Sides
    TWO_SIDED
    group Description
    ANCOVA model was used taking into account center, patient within center-level and within-patient level (over time). This appendix describes the patient within center-level.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Intra-class correlation coefficient
    param Value
    0.41
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
  3. ci Num Sides
    TWO_SIDED
    group Description
    ANCOVA model was used taking into account center, patient within center-level and within-patient level (over time). This appendix describes the within-patient level.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Intra-class correlation coefficient
    param Value
    0.50
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    estimate Comment
    The intra-class correlation coefficient (ICC) was computed to quantify the variability in patient outcome attributable to within-center variability before any patient-level determinants are considered.
    group Description
    ANCOVA model was used taking into account center, patient within center-level and within-patient level (over time). This appendix describes the center-level.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0003
    param Type
    Intra-class correlation coefficient
    param Value
    0.09
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
  2. ci Num Sides
    TWO_SIDED
    group Description
    ANCOVA model was used taking into account center, patient within center-level and within-patient level (over time). This appendix describes the patient within center-level.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Intra-class correlation coefficient
    param Value
    0.41
    statistical Method
    ANCOVA
    tested Non Inferiority
    false
  3. ci Num Sides
    TWO_SIDED
    group Description
    ANCOVA model was used taking into account center, patient within center-level and within-patient level (over time). This appendix describes the within-patient level.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Intra-class correlation coefficient
    param Value
    0.50
    statistical Method
    ANCOVA
    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. Mean and standard error estimated from ANCOVA
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
Evaluable sample
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
Patient/Center-level Covariance Parameter Estimates of Absolute Neutrophil Count
type
PRIMARY
type Units Analyzed
cycles
unit Of Measure
participants

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Preserved source evidence · Not medical advice