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NCT01459653 · OUTCOME

Percentage of Patients With Each EORTC-identified Risk Factors for FN at Baseline

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
percentage of participants
Interval / dispersion
Not reported
Time frame
Enrollment cycle. 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.

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. \* Advanced disease is defined as Stage IV (Stage III or IV if multiple myeloma) AND prior chemotherapy in metastatic setting. The PRS is a quantification of eight individual patient risk factors (EORTC guidelines-2010). CV: cardiovascular; EORTC: European Organization for Research and Treatment in Cancer; FN: febrile neutropenia; Hb: hemoglobin

Analysis population: Evaluable sample

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

Age >=65 years
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP200641.3Not reportedNot reportedNot reportedNot reported
Advanced disease*
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP200613.7Not reportedNot reportedNot reportedNot reported
History of FN
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP20061.9Not reportedNot reportedNot reportedNot reported
No antibiotic prophylaxis
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP200687.8Not reportedNot reportedNot reportedNot reported
Poor performance and/or nutritional status
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP200613.1Not reportedNot reportedNot reportedNot reported
Female gender
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP200661.2Not reportedNot reportedNot reportedNot reported
Hb < 12 g/dL
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP200639.6Not reportedNot reportedNot reportedNot reported
Renal, CV, or liver disease
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP200623.1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        41.3
    title
    Age >=65 years
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        13.7
    title
    Advanced disease*
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1.9
    title
    History of FN
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        87.8
    title
    No antibiotic prophylaxis
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        13.1
    title
    Poor performance and/or nutritional status
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        61.2
    title
    Female gender
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        39.6
    title
    Hb < 12 g/dL
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        23.1
    title
    Renal, CV, or liver disease
denoms
  1. counts
    1. group Id
      OG000
      value
      1447
    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. \* Advanced disease is defined as Stage IV (Stage III or IV if multiple myeloma) AND prior chemotherapy in metastatic setting. The PRS is a quantification of eight individual patient risk factors (EORTC guidelines-2010). CV: cardiovascular; EORTC: European Organization for Research and Treatment in Cancer; FN: febrile neutropenia; Hb: hemoglobin
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
Evaluable sample
reporting Status
POSTED
time Frame
Enrollment cycle. 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.
title
Percentage of Patients With Each EORTC-identified Risk Factors for FN at Baseline
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice