Skip to content
← Full study record

NCT01459653 · OUTCOME

Characteristics of Clusters: ECOG Performance Status

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 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status. ECOG score is a severity scale from 0 to 5 (highest) to grade toxicity and is defined as follows: 0=none, 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=lethal. ECOG is described in more detail by Oken et al, Am J Clin Oncol (CCT) 5:649-655, 1982. FN=Febrile Neutropenia; ECOG: European Cooperative Oncology Group

Analysis population: A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the "high risk group" comprised of only 3.0% of the evaluable sample. Only patients with data in each group are analyzed for ECOG performance status.

Groups in this outcome

EP2006 - Group 1

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

EP2006 - Group 2

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
EP2006 - Group 11145
EP2006 - Group 239

Reported measurements

Source class 1
Values in Scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
EP2006 - Group 10.750.72Not reportedNot reportedNot reported
EP2006 - Group 20.870.61Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.72
        value
        0.75
      2. group Id
        OG001
        spread
        0.61
        value
        0.87
denoms
  1. counts
    1. group Id
      OG000
      value
      1145
    2. group Id
      OG001
      value
      39
    units
    Participants
description
Objective 7: To identify different latent clusters of end-stage cancer patients receiving chemotherapy and being treated with EP2006 for the treatment or primary or secondary prophylaxis of FN using statistical data-mining techniques to profile patients based on medical history, concomitant comorbid conditions, and current clinical status. ECOG score is a severity scale from 0 to 5 (highest) to grade toxicity and is defined as follows: 0=none, 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=lethal. ECOG is described in more detail by Oken et al, Am J Clin Oncol (CCT) 5:649-655, 1982. FN=Febrile Neutropenia; ECOG: European Cooperative Oncology Group
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.
    id
    OG000
    title
    EP2006 - Group 1
  2. description
    Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
    id
    OG001
    title
    EP2006 - Group 2
param Type
MEAN
population Description
A two-group solution converged and the groups differentiated on key baseline variables. However, the group sizes were too unevenly distributed for further analysis with the "high risk group" comprised of only 3.0% of the evaluable sample. Only patients with data in each group are analyzed for ECOG performance status.
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
Characteristics of Clusters: ECOG Performance Status
type
SECONDARY
unit Of Measure
Scores on a scale

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

Preserved source evidence · Not medical advice