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NCT01459653 · OUTCOME

Type of EP 2006 Prophylaxis by Tumor Type

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 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

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 Tumor1117
EP2006: Hematological Tumor330

Reported measurements

Primary (initiated in cycle1)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006: Solid Tumor801Not reportedNot reportedNot reportedNot reported
EP2006: Hematological Tumor245Not reportedNot reportedNot reportedNot reported
Secondary (initiated in ≥cycle2)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006: Solid Tumor316Not reportedNot reportedNot reportedNot reported
EP2006: Hematological Tumor85Not 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
    0.5063
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.5276
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.6483
    param Type
    Odds Ratio (OR)
    param Value
    0.8794
    statistical Method
    Chi-squared
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.5063
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.5276
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.6483
    param Type
    Odds Ratio (OR)
    param Value
    0.8794
    statistical Method
    Chi-squared
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        801
      2. group Id
        OG001
        value
        245
    title
    Primary (initiated in cycle1)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        316
      2. group Id
        OG001
        value
        85
    title
    Secondary (initiated in ≥cycle2)
denoms
  1. counts
    1. group Id
      OG000
      value
      1117
    2. group Id
      OG001
      value
      330
    units
    Participants
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.
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
NUMBER
population Description
Evaluable sample by tumor type
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
Type of EP 2006 Prophylaxis by Tumor Type
type
PRIMARY
unit Of Measure
participants

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Preserved source evidence · Not medical advice