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NCT01459653 · OUTCOME

Number of Patients by Cause of Death

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.

Analysis population: Safety population, i.e. all patients who received at least one dose of study drug

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
EP20061496

Reported measurements

All cause
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP200661Not reportedNot reportedNot reportedNot reported
Cancer-related
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP200641Not reportedNot reportedNot reportedNot reported
Non-cancer related
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP200614Not reportedNot reportedNot reportedNot reported
Cause of death specified as "unknown"
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP20064Not reportedNot reportedNot reportedNot reported
Cause of death not documented
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP20062Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        61
    title
    All cause
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        41
    title
    Cancer-related
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        14
    title
    Non-cancer related
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Cause of death specified as "unknown"
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Cause of death not documented
denoms
  1. counts
    1. group Id
      OG000
      value
      1496
    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.
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
Safety population, i.e. all patients who received at least one dose of study drug
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 Patients by Cause of Death
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice