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NCT01459653 · OUTCOME

Incidence of Outcomes

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 different outcomes and composite outcome by chemotherapy risk group. \^Composite endpoint includes any of 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

Groups in this outcome

EP2006

Cancer patients 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
EP20061447

Reported measurements

CIN grade 4
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP200613.2Not reportedNot reportedNot reportedNot reported
FN
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP20065.9Not reportedNot reportedNot reportedNot reported
CIN/FN related Hospitalization
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP20066.1Not reportedNot reportedNot reportedNot reported
CIN/FN-related chemotherapy disturbance
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP20069.5Not reportedNot reportedNot reportedNot reported
Composite^
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP200622.3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        13.2
    title
    CIN grade 4
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5.9
    title
    FN
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        6.1
    title
    CIN/FN related Hospitalization
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        9.5
    title
    CIN/FN-related chemotherapy disturbance
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        22.3
    title
    Composite^
denoms
  1. counts
    1. group Id
      OG000
      value
      1447
    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 different outcomes and composite outcome by chemotherapy risk group. \^Composite endpoint includes any of 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.
    id
    OG000
    title
    EP2006
param Type
NUMBER
population Description
Evaluable sample
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
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice