Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01459653 · OUTCOME

EP2006 Dose 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
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 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 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 Tumor1104
EP2006: Hematological Tumor328

Analysis denominator · cycles

GroupSource count
EP2006: Solid Tumor4609
EP2006: Hematological Tumor1329

Reported measurements

30 MIU/day
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006: Solid Tumor2296Not reportedNot reportedNot reportedNot reported
EP2006: Hematological Tumor886Not reportedNot reportedNot reportedNot reported
48 MIU/day
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006: Solid Tumor2313Not reportedNot reportedNot reportedNot reported
EP2006: Hematological Tumor443Not 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
    0.3730
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.6605
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Odds Ratio (OR)
    param Value
    0.4963
    statistical Method
    Chi-squared
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.3730
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.6605
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Odds Ratio (OR)
    param Value
    0.4963
    statistical Method
    Chi-squared
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2296
      2. group Id
        OG001
        value
        886
    title
    30 MIU/day
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2313
      2. group Id
        OG001
        value
        443
    title
    48 MIU/day
denom Units Selected
Participants
denoms
  1. counts
    1. group Id
      OG000
      value
      1104
    2. group Id
      OG001
      value
      328
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      4609
    2. group Id
      OG001
      value
      1329
    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.
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
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 Dose by Tumor Type: Cycle Level
type
PRIMARY
type Units Analyzed
cycles
unit Of Measure
cycles

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice