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NCT01459653 · OUTCOME

Number of Patients With CIN/FN Episodes: Patient Level

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 4: To describe hematological outcomes observed in association with primary and secondary prophylactic use of EP2006 in patients at risk for FN; including break-through episodes of FN. CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; Chemotherapy disturbance=dose reduction, delay, and/or cancellation; Composite (any of CIN grade 4, FN, CIN/FN-related hospitalization or CIN/FN-related chemotherapy disturbance) A patient may fall into more than one or none of the categories displayed.

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 any grade
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006504Not reportedNot reportedNot reportedNot reported
CIN grade 3/4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006332Not reportedNot reportedNot reportedNot reported
CIN grade 4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006191Not reportedNot reportedNot reportedNot reported
FN
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP200686Not reportedNot reportedNot reportedNot reported
CIN/FN-related hospitalization
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP200688Not reportedNot reportedNot reportedNot reported
CIN/FN-related chemotherapy disturbance
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006138Not reportedNot reportedNot reportedNot reported
Composite
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006323Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        504
    title
    CIN any grade
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        332
    title
    CIN grade 3/4
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        191
    title
    CIN grade 4
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        86
    title
    FN
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        88
    title
    CIN/FN-related hospitalization
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        138
    title
    CIN/FN-related chemotherapy disturbance
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        323
    title
    Composite
denoms
  1. counts
    1. group Id
      OG000
      value
      1447
    units
    Participants
description
Objective 4: To describe hematological outcomes observed in association with primary and secondary prophylactic use of EP2006 in patients at risk for FN; including break-through episodes of FN. CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; Chemotherapy disturbance=dose reduction, delay, and/or cancellation; Composite (any of CIN grade 4, FN, CIN/FN-related hospitalization or CIN/FN-related chemotherapy disturbance) A patient may fall into more than one or none of the categories displayed.
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
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 With CIN/FN Episodes: Patient Level
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice