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NCT01459653 · OUTCOME

GCSF Persistence Score (GPS)

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 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes. The GPS grades persistence based on the number of cycles in the line of chemotherapy in which EP2006 was administered, D, relative to the number of cycles in which it should have been continued, C. Thus, the GPS = D/C and ranges from 0 to 1.0 ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; EORTC=European Organization for Research and Treatment in Cancer; FN=Febrile Neutropenia; GCSF=Granulocyte Colony-Stimulating Factor

Analysis population: Patients in the evaluable sample with a GCSF persistence score (GPS).

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
EP20061295

Reported measurements

GPS score 0
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006123Not reportedNot reportedNot reportedNot reported
GPS score 0.33
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP20062Not reportedNot reportedNot reportedNot reported
GPS score 0.50
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP20063Not reportedNot reportedNot reportedNot reported
GPS score 0.60
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP20062Not reportedNot reportedNot reportedNot reported
GPS score 0.67
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP20064Not reportedNot reportedNot reportedNot reported
GPS score 0.75
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP20061Not reportedNot reportedNot reportedNot reported
GPS score 0.80
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP20063Not reportedNot reportedNot reportedNot reported
GPS score 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP20061157Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        123
    title
    GPS score 0
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    GPS score 0.33
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    GPS score 0.50
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    GPS score 0.60
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    GPS score 0.67
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    GPS score 0.75
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    GPS score 0.80
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1157
    title
    GPS score 1
denoms
  1. counts
    1. group Id
      OG000
      value
      1295
    units
    Participants
description
Objective 3: To determine the extent to which the primary and secondary prophylaxis of FN in cancer patients is in congruence with the EORTC best practice guidelines and dosing recommendations, and whether this is associated with better outcomes. The GPS grades persistence based on the number of cycles in the line of chemotherapy in which EP2006 was administered, D, relative to the number of cycles in which it should have been continued, C. Thus, the GPS = D/C and ranges from 0 to 1.0 ANC=Absolute Neutrophil Count; CIN=Chemotherapy-Induced Neutropenia; EORTC=European Organization for Research and Treatment in Cancer; FN=Febrile Neutropenia; GCSF=Granulocyte Colony-Stimulating Factor
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
Patients in the evaluable sample with a GCSF persistence score (GPS).
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
GCSF Persistence Score (GPS)
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice