Skip to content
← Full study record

NCT01459653 · OUTCOME

Patient Risk Score (PRS) for Patients Receiving Chemotherapy With 10-20% FN Risk by Tumor Type

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
MEAN
Unit
Scores on a scale
Interval / dispersion
Standard Deviation
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. Patient risk score (PRS) shows the individual patient risk for FN.The PRS is a sum of eight weighted individual patient risk factors for FN and results in a possible score of 0 to 11 (highest risk for FN). The risk factors were assigned weights based on the level of risk specified by guidelines and SC consensus (age \> 65 years: 3.0; advanced disease: 1.5; history of FN: 3.0; No antibiotic prophylaxis: 0.5; poor performance/nutritional status: 1.5; female gender: 0.5; Hb\<12g/dL: 0.5; Renal, CV or liver disease: 0.5). Advanced disease: Stage IV or Stage III + prior chemotherapy in metastatic setting; CV: cardiovascular; EORTC: European Organization for Research and Treatment in Cancer; FN: febrile neutropenia

Analysis population: Patients with chemotherapy with 10-20% risk of FN in the evaluable sample by tumor type

Groups in this outcome

EP2006 - All Patients

Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (all patients).

EP2006 - Solid Tumor

Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (Solid tumor).

EP2006 - Hematological Tumor

Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (Hematological tumor).

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 - All Patients650
EP2006 - Solid Tumor568
EP2006 - Hematological Tumor82

Reported measurements

Source class 1
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
EP2006 - All Patients3.32.0Not reportedNot reportedNot reported
EP2006 - Solid Tumor3.21.9Not reportedNot reportedNot reported
EP2006 - Hematological Tumor3.42.4Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.0
        value
        3.3
      2. group Id
        OG001
        spread
        1.9
        value
        3.2
      3. group Id
        OG002
        spread
        2.4
        value
        3.4
denoms
  1. counts
    1. group Id
      OG000
      value
      650
    2. group Id
      OG001
      value
      568
    3. group Id
      OG002
      value
      82
    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. Patient risk score (PRS) shows the individual patient risk for FN.The PRS is a sum of eight weighted individual patient risk factors for FN and results in a possible score of 0 to 11 (highest risk for FN). The risk factors were assigned weights based on the level of risk specified by guidelines and SC consensus (age \> 65 years: 3.0; advanced disease: 1.5; history of FN: 3.0; No antibiotic prophylaxis: 0.5; poor performance/nutritional status: 1.5; female gender: 0.5; Hb\<12g/dL: 0.5; Renal, CV or liver disease: 0.5). Advanced disease: Stage IV or Stage III + prior chemotherapy in metastatic setting; CV: cardiovascular; EORTC: European Organization for Research and Treatment in Cancer; FN: febrile neutropenia
dispersion Type
Standard Deviation
groups
  1. description
    Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (all patients).
    id
    OG000
    title
    EP2006 - All Patients
  2. description
    Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (Solid tumor).
    id
    OG001
    title
    EP2006 - Solid Tumor
  3. description
    Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (Hematological tumor).
    id
    OG002
    title
    EP2006 - Hematological Tumor
param Type
MEAN
population Description
Patients with chemotherapy with 10-20% risk of FN in the evaluable sample by tumor type
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
Patient Risk Score (PRS) for Patients Receiving Chemotherapy With 10-20% FN Risk by Tumor Type
type
PRIMARY
unit Of Measure
Scores on a scale

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

Preserved source evidence · Not medical advice