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NCT01459653 · OUTCOME

Number of Participants With Cancer-related Mortality by Any CIN/FN-related Chemotherapy Disturbance

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 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 number of patients who had a cancer-related death by any/no CIN/FN-related chemotherapy disturbance CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia

Analysis population: Evaluable sample by any/no CIN/FN-related chemotherapy disturbance with data

Groups in this outcome

EP2006: Any CIN/FN-related Chemotherapy Disturbance

Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN who had any CIN/FN-related chemotherapy disturbance

EP2006: No CIN/FN-related Chemotherapy Disturbance

Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN who had no CIN/FN-related chemotherapy disturbance

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: Any CIN/FN-related Chemotherapy Disturbance138
EP2006: No CIN/FN-related Chemotherapy Disturbance1303

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006: Any CIN/FN-related Chemotherapy Disturbance2Not reportedNot reportedNot reportedNot reported
EP2006: No CIN/FN-related Chemotherapy Disturbance33Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.3830
    statistical Method
    Log Rank
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.3830
    statistical Method
    Log Rank
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        33
denoms
  1. counts
    1. group Id
      OG000
      value
      138
    2. group Id
      OG001
      value
      1303
    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 number of patients who had a cancer-related death by any/no 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 who had any CIN/FN-related chemotherapy disturbance
    id
    OG000
    title
    EP2006: Any CIN/FN-related Chemotherapy Disturbance
  2. description
    Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN who had no CIN/FN-related chemotherapy disturbance
    id
    OG001
    title
    EP2006: No CIN/FN-related Chemotherapy Disturbance
param Type
NUMBER
population Description
Evaluable sample by any/no CIN/FN-related chemotherapy disturbance with data
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
Number of Participants With Cancer-related Mortality by Any CIN/FN-related Chemotherapy Disturbance
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice