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NCT01459653 · OUTCOME

Incidence of Outcomes by Study Drug Duration: 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
percentage of 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 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table presents incidences of outcomes on a cycle level by study drug duration. \^Composite outcome includes CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia;

Analysis population: Evaluable sample by study drug duration. As these are cycle-level analyses and since patients can be in more than one category over the course of the study, the sum of patients of all three categories may exceed the sample size.

Groups in this outcome

EP2006: 1-3 Days Duration

Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with 1-3 days of study drug duration.

EP2006: 4-5 Days Duration

Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with 4-5 days of study drug duration.

EP2006: >=6 Days Duration

Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with \>=6 days of study drug duration.

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: 1-3 Days Duration380
EP2006: 4-5 Days Duration784
EP2006: >=6 Days Duration419

Reported measurements

CIN grade 4
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006: 1-3 Days Duration3.6Not reportedNot reportedNot reportedNot reported
EP2006: 4-5 Days Duration3.9Not reportedNot reportedNot reportedNot reported
EP2006: >=6 Days Duration5.5Not reportedNot reportedNot reportedNot reported
FN
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006: 1-3 Days Duration1.2Not reportedNot reportedNot reportedNot reported
EP2006: 4-5 Days Duration1.2Not reportedNot reportedNot reportedNot reported
EP2006: >=6 Days Duration2.2Not reportedNot reportedNot reportedNot reported
CIN/FN-related chemotherapy disturbance
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006: 1-3 Days Duration2.0Not reportedNot reportedNot reportedNot reported
EP2006: 4-5 Days Duration2.1Not reportedNot reportedNot reportedNot reported
EP2006: >=6 Days Duration4.7Not reportedNot reportedNot reportedNot reported
Composite^
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006: 1-3 Days Duration6.0Not reportedNot reportedNot reportedNot reported
EP2006: 4-5 Days Duration5.8Not reportedNot reportedNot reportedNot reported
EP2006: >=6 Days Duration9.3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3.6
      2. group Id
        OG001
        value
        3.9
      3. group Id
        OG002
        value
        5.5
    title
    CIN grade 4
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1.2
      2. group Id
        OG001
        value
        1.2
      3. group Id
        OG002
        value
        2.2
    title
    FN
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2.0
      2. group Id
        OG001
        value
        2.1
      3. group Id
        OG002
        value
        4.7
    title
    CIN/FN-related chemotherapy disturbance
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        6.0
      2. group Id
        OG001
        value
        5.8
      3. group Id
        OG002
        value
        9.3
    title
    Composite^
denoms
  1. counts
    1. group Id
      OG000
      value
      380
    2. group Id
      OG001
      value
      784
    3. group Id
      OG002
      value
      419
    units
    Participants
description
Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table presents incidences of outcomes on a cycle level by study drug duration. \^Composite outcome includes CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia;
groups
  1. description
    Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with 1-3 days of study drug duration.
    id
    OG000
    title
    EP2006: 1-3 Days Duration
  2. description
    Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with 4-5 days of study drug duration.
    id
    OG001
    title
    EP2006: 4-5 Days Duration
  3. description
    Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with \>=6 days of study drug duration.
    id
    OG002
    title
    EP2006: >=6 Days Duration
param Type
NUMBER
population Description
Evaluable sample by study drug duration. As these are cycle-level analyses and since patients can be in more than one category over the course of the study, the sum of patients of all three categories may exceed the sample size.
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
Incidence of Outcomes by Study Drug Duration: Cycle Level
type
PRIMARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice