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NCT01459653 · OUTCOME

EP2006 Day of Initiation: Cycle Distribution

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 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery. Table presents number of cycles by day after chemotherapy.

Analysis population: Cycles of patients in evaluable sample with day of study drug initiation

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

Analysis denominator · cycles

GroupSource count
EP20065930

Reported measurements

day 0
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006795Not reportedNot reportedNot reportedNot reported
day1
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP20061818Not reportedNot reportedNot reportedNot reported
day 2
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006793Not reportedNot reportedNot reportedNot reported
day 3
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006541Not reportedNot reportedNot reportedNot reported
day 4
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006270Not reportedNot reportedNot reportedNot reported
day 5
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006404Not reportedNot reportedNot reportedNot reported
day 6
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006400Not reportedNot reportedNot reportedNot reported
day 7
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006429Not reportedNot reportedNot reportedNot reported
day 8
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006231Not reportedNot reportedNot reportedNot reported
day 9
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP200659Not reportedNot reportedNot reportedNot reported
day10
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP200649Not reportedNot reportedNot reportedNot reported
day11
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP200636Not reportedNot reportedNot reportedNot reported
≥day12
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006105Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        795
    title
    day 0
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1818
    title
    day1
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        793
    title
    day 2
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        541
    title
    day 3
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        270
    title
    day 4
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        404
    title
    day 5
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        400
    title
    day 6
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        429
    title
    day 7
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        231
    title
    day 8
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        59
    title
    day 9
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        49
    title
    day10
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        36
    title
    day11
denom Units Selected
Participants
denoms
  1. counts
    1. group Id
      OG000
      value
      1447
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      5930
    units
    cycles
description
Objective 2: To describe EP2006 primary or secondary prophylaxis patterns for FN over up to 6 cycles of chemotherapy, with or without prior, concurrent, or later radiotherapy or surgery. Table presents number of cycles by day after chemotherapy.
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
Cycles of patients in evaluable sample with day of study drug initiation
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
EP2006 Day of Initiation: Cycle Distribution
type
PRIMARY
type Units Analyzed
cycles
unit Of Measure
cycles

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Preserved source evidence · Not medical advice