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NCT01459653 · OUTCOME

Patient-level Predictors for All-cause Mortality

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 10: To model patient- and center-level variables between patients who died vs. survived during the course of primary or secondary prophylaxis with EP2006, in all patients and those with break-through FN episodes. Table presents patient-level predictors for all-cause mortality: history of anemia at enrollment, liver/renal/cardiac comorbidity, poor performance (ECOG \>=2) during study

Analysis population: Evaluable sample with data

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
EP20061272

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP20061272Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    1.1931
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.0803
    group Description
    Patient level predictor: History of anemia at enrollment
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0116
    param Type
    Odds Ratio (OR)
    param Value
    2.2064
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  2. ci Lower Limit
    1.2754
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.1656
    group Description
    Liver/renal/cardiac comorbidity as patient level predictor
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0057
    param Type
    Odds Ratio (OR)
    param Value
    2.3049
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  3. ci Lower Limit
    8.2159
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    37.4243
    group Description
    Poor performance (ECOG \>=2) during study as patient level predictor
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Odds Ratio (OR)
    param Value
    17.5350
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    1.1931
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.0803
    group Description
    Patient level predictor: History of anemia at enrollment
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0116
    param Type
    Odds Ratio (OR)
    param Value
    2.2064
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  2. ci Lower Limit
    1.2754
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.1656
    group Description
    Liver/renal/cardiac comorbidity as patient level predictor
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0057
    param Type
    Odds Ratio (OR)
    param Value
    2.3049
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
  3. ci Lower Limit
    8.2159
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    37.4243
    group Description
    Poor performance (ECOG \>=2) during study as patient level predictor
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    param Type
    Odds Ratio (OR)
    param Value
    17.5350
    statistical Method
    Regression, Logistic
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1272
denoms
  1. counts
    1. group Id
      OG000
      value
      1272
    units
    Participants
description
Objective 10: To model patient- and center-level variables between patients who died vs. survived during the course of primary or secondary prophylaxis with EP2006, in all patients and those with break-through FN episodes. Table presents patient-level predictors for all-cause mortality: history of anemia at enrollment, liver/renal/cardiac comorbidity, poor performance (ECOG \>=2) during study
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 with data
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
Patient-level Predictors for All-cause Mortality
type
SECONDARY
unit Of Measure
participants

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Preserved source evidence · Not medical advice