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NCT01459653 · OUTCOME

Incidence of Outcomes by Mean GIS: Patient 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 by day (mean GIS over all visits). \^Composite outcome includes CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010).

Analysis population: Evaluable sample by mean GIS

Groups in this outcome

EP2006: Mean GIS 0-0.5

Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with mean GIS 0-0.5

EP2006: Mean GIS 0.51-0.99

Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with mean GIS 0.51-0.99

EP2006: Mean GIS 1

Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with mean GIS 1

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: Mean GIS 0-0.5390
EP2006: Mean GIS 0.51-0.99308
EP2006: Mean GIS 1725

Reported measurements

CIN grade 4
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006: Mean GIS 0-0.517.7Not reportedNot reportedNot reportedNot reported
EP2006: Mean GIS 0.51-0.9917.5Not reportedNot reportedNot reportedNot reported
EP2006: Mean GIS 19.2Not reportedNot reportedNot reportedNot reported
Composite^
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006: Mean GIS 0-0.526.9Not reportedNot reportedNot reportedNot reported
EP2006: Mean GIS 0.51-0.9924.7Not reportedNot reportedNot reportedNot reported
EP2006: Mean GIS 118.9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        17.7
      2. group Id
        OG001
        value
        17.5
      3. group Id
        OG002
        value
        9.2
    title
    CIN grade 4
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        26.9
      2. group Id
        OG001
        value
        24.7
      3. group Id
        OG002
        value
        18.9
    title
    Composite^
denoms
  1. counts
    1. group Id
      OG000
      value
      390
    2. group Id
      OG001
      value
      308
    3. group Id
      OG002
      value
      725
    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 by day (mean GIS over all visits). \^Composite outcome includes CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010).
groups
  1. description
    Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with mean GIS 0-0.5
    id
    OG000
    title
    EP2006: Mean GIS 0-0.5
  2. description
    Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with mean GIS 0.51-0.99
    id
    OG001
    title
    EP2006: Mean GIS 0.51-0.99
  3. description
    Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with mean GIS 1
    id
    OG002
    title
    EP2006: Mean GIS 1
param Type
NUMBER
population Description
Evaluable sample by mean GIS
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 Mean GIS: Patient Level
type
PRIMARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice