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NCT01459653 · OUTCOME

Cancer Treatment Type - Ever Received During Study

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 1: To describe the cancer patients requiring chemotherapy who, in their treating physician's best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications. ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; FN=Febrile Neutropenia;

Analysis population: The evaluable sample includes all patients in the safety sample (all patients who received at least one dose of the study medication) who had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data).

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

Surgery
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006100Not reportedNot reportedNot reportedNot reported
Radiotherapy
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006102Not reportedNot reportedNot reportedNot reported
Hormonal therapy
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP200685Not reportedNot reportedNot reportedNot reported
Targeted treatment
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP200689Not reportedNot reportedNot reportedNot reported
Bone marrow transplant
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP200631Not reportedNot reportedNot reportedNot reported
Other (e.g., CAM)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP200698Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        100
    title
    Surgery
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        102
    title
    Radiotherapy
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        85
    title
    Hormonal therapy
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        89
    title
    Targeted treatment
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        31
    title
    Bone marrow transplant
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        98
    title
    Other (e.g., CAM)
denoms
  1. counts
    1. group Id
      OG000
      value
      1447
    units
    Participants
description
Objective 1: To describe the cancer patients requiring chemotherapy who, in their treating physician's best clinical judgment, are receiving EP2006 for the primary or secondary prophylaxis of FN in terms of demographics, clinical status, medical history, concomitant comorbid conditions and current status of disease, and prior and concomitant medications. ANC=Absolute Neutrophil Count; 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.
    id
    OG000
    title
    EP2006
param Type
NUMBER
population Description
The evaluable sample includes all patients in the safety sample (all patients who received at least one dose of the study medication) who had no major protocol violation and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN 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
Cancer Treatment Type - Ever Received During Study
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice