Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01459653 · OUTCOME

EP2006 Day of Initiation Relative to Guidelines by Cancer 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
NUMBER
Unit
cycles
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 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. \^ 168 cycles in which ZARZIO® was initiated on day 4 or later involved regimens deemed by the Study Steering Committee to be suitable for GCSF initiation any day after chemotherapy (day 1 or later), e.g., etoposide; hence, these patients were re-classified as being within guidelines DLBCL- Diffuse Large B-Cell Lymphoma. Guidelines refers to EORTC 2010 guidelines

Analysis population: Number of cycles with initiation on different days during chemotherapy for evaluable sample. A patient may have initiated EP2006 during chemotherapy on different days for different cycles. The categories therefore are not mutually exclusive on a patient level and the sum of patients may therefore exceed the sample size.

Groups in this outcome

EP2006: EP2006 Initiation During Chemotherapy (Day 0)

Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (EP2006 initiation during chemotherapy, day 0).

EP2006: EP 2006 Initiation Per Guidelines (Days 1-3)

Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (EP 2006 initiation per guidelines (days 1-3).

EP2006: EP2006 Initiation Later (Day 4 or More)^

Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (EP2006 initiation later (day 4 or more).

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: EP2006 Initiation During Chemotherapy (Day 0)234
EP2006: EP 2006 Initiation Per Guidelines (Days 1-3)851
EP2006: EP2006 Initiation Later (Day 4 or More)^473

Analysis denominator · cycles

GroupSource count
EP2006: EP2006 Initiation During Chemotherapy (Day 0)795
EP2006: EP 2006 Initiation Per Guidelines (Days 1-3)3320
EP2006: EP2006 Initiation Later (Day 4 or More)^1815

Reported measurements

Breast
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006: EP2006 Initiation During Chemotherapy (Day 0)178Not reportedNot reportedNot reportedNot reported
EP2006: EP 2006 Initiation Per Guidelines (Days 1-3)1410Not reportedNot reportedNot reportedNot reported
EP2006: EP2006 Initiation Later (Day 4 or More)^624Not reportedNot reportedNot reportedNot reported
Lung
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006: EP2006 Initiation During Chemotherapy (Day 0)305Not reportedNot reportedNot reportedNot reported
EP2006: EP 2006 Initiation Per Guidelines (Days 1-3)691Not reportedNot reportedNot reportedNot reported
EP2006: EP2006 Initiation Later (Day 4 or More)^225Not reportedNot reportedNot reportedNot reported
Lymphoma (DLBCL)
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006: EP2006 Initiation During Chemotherapy (Day 0)23Not reportedNot reportedNot reportedNot reported
EP2006: EP 2006 Initiation Per Guidelines (Days 1-3)386Not reportedNot reportedNot reportedNot reported
EP2006: EP2006 Initiation Later (Day 4 or More)^671Not reportedNot reportedNot reportedNot reported
Ovarian
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006: EP2006 Initiation During Chemotherapy (Day 0)109Not reportedNot reportedNot reportedNot reported
EP2006: EP 2006 Initiation Per Guidelines (Days 1-3)332Not reportedNot reportedNot reportedNot reported
EP2006: EP2006 Initiation Later (Day 4 or More)^119Not reportedNot reportedNot reportedNot reported
Prostate
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006: EP2006 Initiation During Chemotherapy (Day 0)26Not reportedNot reportedNot reportedNot reported
EP2006: EP 2006 Initiation Per Guidelines (Days 1-3)278Not reportedNot reportedNot reportedNot reported
EP2006: EP2006 Initiation Later (Day 4 or More)^95Not reportedNot reportedNot reportedNot reported
Multiple myeloma
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006: EP2006 Initiation During Chemotherapy (Day 0)32Not reportedNot reportedNot reportedNot reported
EP2006: EP 2006 Initiation Per Guidelines (Days 1-3)167Not reportedNot reportedNot reportedNot reported
EP2006: EP2006 Initiation Later (Day 4 or More)^37Not reportedNot reportedNot reportedNot reported
Bladder
Values in cycles · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
EP2006: EP2006 Initiation During Chemotherapy (Day 0)122Not reportedNot reportedNot reportedNot reported
EP2006: EP 2006 Initiation Per Guidelines (Days 1-3)56Not reportedNot reportedNot reportedNot reported
EP2006: EP2006 Initiation Later (Day 4 or More)^44Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    statistical Method
    Chi-squared
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    statistical Method
    Chi-squared
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        178
      2. group Id
        OG001
        value
        1410
      3. group Id
        OG002
        value
        624
    title
    Breast
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        305
      2. group Id
        OG001
        value
        691
      3. group Id
        OG002
        value
        225
    title
    Lung
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        386
      3. group Id
        OG002
        value
        671
    title
    Lymphoma (DLBCL)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        109
      2. group Id
        OG001
        value
        332
      3. group Id
        OG002
        value
        119
    title
    Ovarian
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        278
      3. group Id
        OG002
        value
        95
    title
    Prostate
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        32
      2. group Id
        OG001
        value
        167
      3. group Id
        OG002
        value
        37
    title
    Multiple myeloma
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        122
      2. group Id
        OG001
        value
        56
      3. group Id
        OG002
        value
        44
    title
    Bladder
denom Units Selected
Participants
denoms
  1. counts
    1. group Id
      OG000
      value
      234
    2. group Id
      OG001
      value
      851
    3. group Id
      OG002
      value
      473
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      795
    2. group Id
      OG001
      value
      3320
    3. group Id
      OG002
      value
      1815
    units
    cycles
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. \^ 168 cycles in which ZARZIO® was initiated on day 4 or later involved regimens deemed by the Study Steering Committee to be suitable for GCSF initiation any day after chemotherapy (day 1 or later), e.g., etoposide; hence, these patients were re-classified as being within guidelines DLBCL- Diffuse Large B-Cell Lymphoma. Guidelines refers to EORTC 2010 guidelines
groups
  1. description
    Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (EP2006 initiation during chemotherapy, day 0).
    id
    OG000
    title
    EP2006: EP2006 Initiation During Chemotherapy (Day 0)
  2. description
    Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (EP 2006 initiation per guidelines (days 1-3).
    id
    OG001
    title
    EP2006: EP 2006 Initiation Per Guidelines (Days 1-3)
  3. description
    Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (EP2006 initiation later (day 4 or more).
    id
    OG002
    title
    EP2006: EP2006 Initiation Later (Day 4 or More)^
param Type
NUMBER
population Description
Number of cycles with initiation on different days during chemotherapy for evaluable sample. A patient may have initiated EP2006 during chemotherapy on different days for different cycles. The categories therefore are not mutually exclusive on a patient level and the sum of patients may therefore exceed the sample size.
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
EP2006 Day of Initiation Relative to Guidelines by Cancer Type
type
PRIMARY
type Units Analyzed
cycles
unit Of Measure
cycles

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

Preserved source evidence · Not medical advice