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NCT01459653 · OUTCOME

CIN/FN Episodes: Cycle 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
cycles
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. Chemotherapy-Induced Neutropenia (CIN); Febrile Neutropenia (FN); Chemotherapy disturbance=dose reduction, delay, and/or cancellation; Composite (any of CIN grade 4, FN, CIN/FN-related hospitalization \[RH\] or CIN/FN-related chemotherapy disturbance \[RCD\])

Analysis population: Number of cycles in evaluable sample

Groups in this outcome

EP2006 Cycle Level

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
EP2006 Cycle Level1447

Analysis denominator · cycles

GroupSource count
EP2006 Cycle Level7570

Reported measurements

CIN any grade (n=7557)
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006 Cycle Level1083Not reportedNot reportedNot reportedNot reported
CIN grade 3/4 (n=7541)
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006 Cycle Level602Not reportedNot reportedNot reportedNot reported
CIN grade 4 (n=7541)
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006 Cycle Level294Not reportedNot reportedNot reportedNot reported
FN (n=7532)
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006 Cycle Level105Not reportedNot reportedNot reportedNot reported
CIN/FN-RH (n=7531)
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006 Cycle Level111Not reportedNot reportedNot reportedNot reported
CIN/FN-RCD (n=6213)
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006 Cycle Level174Not reportedNot reportedNot reportedNot reported
Composite (n=7570)
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006 Cycle Level507Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1083
    title
    CIN any grade (n=7557)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        602
    title
    CIN grade 3/4 (n=7541)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        294
    title
    CIN grade 4 (n=7541)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        105
    title
    FN (n=7532)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        111
    title
    CIN/FN-RH (n=7531)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        174
    title
    CIN/FN-RCD (n=6213)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        507
    title
    Composite (n=7570)
denom Units Selected
Participants
denoms
  1. counts
    1. group Id
      OG000
      value
      1447
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      7570
    units
    cycles
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. Chemotherapy-Induced Neutropenia (CIN); Febrile Neutropenia (FN); Chemotherapy disturbance=dose reduction, delay, and/or cancellation; Composite (any of CIN grade 4, FN, CIN/FN-related hospitalization \[RH\] or CIN/FN-related chemotherapy disturbance \[RCD\])
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 Cycle Level
param Type
NUMBER
population Description
Number of cycles in evaluable sample
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
CIN/FN Episodes: Cycle Level
type
PRIMARY
type Units Analyzed
cycles
unit Of Measure
cycles

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

Preserved source evidence · Not medical advice