Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01459653 · OUTCOME

Clinical Events Ever During Study (Frequency Threshold: 5%)

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

Bone pain
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006357Not reportedNot reportedNot reportedNot reported
Thrombocytopenia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006230Not reportedNot reportedNot reportedNot reported
Serum LDH increase
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006222Not reportedNot reportedNot reportedNot reported
Muscle pain
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006210Not reportedNot reportedNot reportedNot reported
Joint pain
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006200Not reportedNot reportedNot reportedNot reported
Serum GGT increase
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006178Not reportedNot reportedNot reportedNot reported
Serum ALP increase
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006168Not reportedNot reportedNot reportedNot reported
Other neurological symptoms
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006102Not reportedNot reportedNot reportedNot reported
Headache
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006100Not reportedNot reportedNot reportedNot reported
Blood uric acid increase
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP200688Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        357
    title
    Bone pain
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        230
    title
    Thrombocytopenia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        222
    title
    Serum LDH increase
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        210
    title
    Muscle pain
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        200
    title
    Joint pain
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        178
    title
    Serum GGT increase
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        168
    title
    Serum ALP increase
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        102
    title
    Other neurological symptoms
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        100
    title
    Headache
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        88
    title
    Blood uric acid increase
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
Clinical Events Ever During Study (Frequency Threshold: 5%)
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice