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NCT01459653 · OUTCOME

Incidence of Outcomes by Chemotherapy Risk: Patient 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
percentage of 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 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table presents incidences of different outcomes and composite outcome by chemotherapy risk group. \^Composite endpoint includes any of CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance. CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010).

Analysis population: Evaluable sample by chemotherapy risk

Groups in this outcome

EP2006: Low (<10%) Risk

Cancer patients treated with chemotherapy with low risk(\<10%) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.

EP2006: Medium (10-20%) Risk

Cancer patients treated with chemotherapy with medium risk(10-20%) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.

EP2006: High (>20%) Risk

Cancer patients treated with chemotherapy with high risk(\>20%) 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: Low (<10%) Risk154
EP2006: Medium (10-20%) Risk650
EP2006: High (>20%) Risk640

Reported measurements

CIN grade 4
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006: Low (<10%) Risk7.8Not reportedNot reportedNot reportedNot reported
EP2006: Medium (10-20%) Risk11.8Not reportedNot reportedNot reportedNot reported
EP2006: High (>20%) Risk15.9Not reportedNot reportedNot reportedNot reported
FN
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006: Low (<10%) Risk3.9Not reportedNot reportedNot reportedNot reported
EP2006: Medium (10-20%) Risk3.5Not reportedNot reportedNot reportedNot reported
EP2006: High (>20%) Risk8.9Not reportedNot reportedNot reportedNot reported
Composite^
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006: Low (<10%) Risk16.9Not reportedNot reportedNot reportedNot reported
EP2006: Medium (10-20%) Risk20.9Not reportedNot reportedNot reportedNot reported
EP2006: High (>20%) Risk25.2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        7.8
      2. group Id
        OG001
        value
        11.8
      3. group Id
        OG002
        value
        15.9
    title
    CIN grade 4
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3.9
      2. group Id
        OG001
        value
        3.5
      3. group Id
        OG002
        value
        8.9
    title
    FN
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        16.9
      2. group Id
        OG001
        value
        20.9
      3. group Id
        OG002
        value
        25.2
    title
    Composite^
denoms
  1. counts
    1. group Id
      OG000
      value
      154
    2. group Id
      OG001
      value
      650
    3. group Id
      OG002
      value
      640
    units
    Participants
description
Objective 5: To describe the distribution of chemotherapy dose delays and reductions, surgery delays and cancellations, radiotherapy delays, dose reductions, and cancellations, and mortality (GCSF-related; FN-related; cancer-related; not related to GCSF, FN, or cancer; all-cause); and estimate the time-to-event for such events over the course of EP2006 treatment. Table presents incidences of different outcomes and composite outcome by chemotherapy risk group. \^Composite endpoint includes any of CIN grade 4, FN, CIN/FN-related hospitalization and CIN/FN-related chemotherapy disturbance. CIN: Chemotherapy-Induced Neutropenia; FN: Febrile Neutropenia; ANC: Absolute Neutrophil count; GIS: GCSF Initiation Score; Prophylaxis decision mentioned below are relative to EORTC guidelines (2010).
groups
  1. description
    Cancer patients treated with chemotherapy with low risk(\<10%) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
    id
    OG000
    title
    EP2006: Low (<10%) Risk
  2. description
    Cancer patients treated with chemotherapy with medium risk(10-20%) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
    id
    OG001
    title
    EP2006: Medium (10-20%) Risk
  3. description
    Cancer patients treated with chemotherapy with high risk(\>20%) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
    id
    OG002
    title
    EP2006: High (>20%) Risk
param Type
NUMBER
population Description
Evaluable sample by chemotherapy risk
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
Incidence of Outcomes by Chemotherapy Risk: Patient Level
type
PRIMARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice