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NCT01459653 · OUTCOME

EP2006 Duration by Tumor Type: 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
MEAN
Unit
days
Interval / dispersion
Standard Deviation
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 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.

Analysis population: Evaluable sample by tumor type with data

Groups in this outcome

EP2006: Solid Tumor

Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.

EP2006: Hematological Tumor

Cancer patients with hematological tumor 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
EP2006: Solid Tumor1103
EP2006: Hematological Tumor323

Analysis denominator · cycles

GroupSource count
EP2006: Solid Tumor4619
EP2006: Hematological Tumor1323

Reported measurements

Source class 1
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
EP2006: Solid Tumor5.142.24Not reportedNot reportedNot reported
EP2006: Hematological Tumor5.032.56Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    -0.0075
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.2136
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0677
    param Type
    Slope
    param Value
    0.1031
    statistical Comment
    degrees of freedom: 4516
    statistical Method
    ANOVA
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    -0.0075
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.2136
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0677
    param Type
    Slope
    param Value
    0.1031
    statistical Comment
    degrees of freedom: 4516
    statistical Method
    ANOVA
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.24
        value
        5.14
      2. group Id
        OG001
        spread
        2.56
        value
        5.03
denom Units Selected
Participants
denoms
  1. counts
    1. group Id
      OG000
      value
      1103
    2. group Id
      OG001
      value
      323
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      4619
    2. group Id
      OG001
      value
      1323
    units
    cycles
description
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery.
dispersion Type
Standard Deviation
groups
  1. description
    Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
    id
    OG000
    title
    EP2006: Solid Tumor
  2. description
    Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
    id
    OG001
    title
    EP2006: Hematological Tumor
param Type
MEAN
population Description
Evaluable sample by tumor type 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
EP2006 Duration by Tumor Type: Cycle Level
type
PRIMARY
type Units Analyzed
cycles
unit Of Measure
days

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Preserved source evidence · Not medical advice