NCT01459653 · OUTCOME

Incidence of Outcomes by Day of Study Drug Initiation: Cycle 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 outcomes on a cycle level by day of study drug initiation. \^Composite outcome includes 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). \*Day of EP2006 initiation- Day 0 (during chemotherapy); \*\*Day of EP2006 initiation- Days 1-3 (per guidelines)

Analysis population: Evaluable sample by day of study drug initiation. As these are cycle-level analyses and since patients can be in more than one category over the course of the study, the sum of patients of all three categories may exceed the sample size.

Groups in this outcome

EP2006: Day 0 (During Chemotherapy)

Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN that initiated study drug on day 0 (during chemotherapy)

EP2006: Days 1-3 (Per Guidelines)

EP2006: Day 4 or Later

Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN that initiated study drug on day 4 or later

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
EP2006: Day 0 (During Chemotherapy)	234
EP2006: Days 1-3 (Per Guidelines)	851
EP2006: Day 4 or Later	473

Reported measurements

CIN grade 4

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
EP2006: Day 0 (During Chemotherapy)	3.1	Not reported	Not reported	Not reported	Not reported
EP2006: Days 1-3 (Per Guidelines)	2.8	Not reported	Not reported	Not reported	Not reported
EP2006: Day 4 or Later	7.3	Not reported	Not reported	Not reported	Not reported

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
EP2006: Day 0 (During Chemotherapy)	1.0	Not reported	Not reported	Not reported	Not reported
EP2006: Days 1-3 (Per Guidelines)	1.2	Not reported	Not reported	Not reported	Not reported
EP2006: Day 4 or Later	2.1	Not reported	Not reported	Not reported	Not reported

Composite^

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
EP2006: Day 0 (During Chemotherapy)	5.8	Not reported	Not reported	Not reported	Not reported
EP2006: Days 1-3 (Per Guidelines)	5.4	Not reported	Not reported	Not reported	Not reported
EP2006: Day 4 or Later	9.1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
3.1
group Id
OG001
value
2.8
group Id
OG002
value
7.3
title
CIN grade 4
categories
measurements
group Id
OG000
value
1.0
group Id
OG001
value
1.2
group Id
OG002
value
2.1
title
FN
categories
measurements
group Id
OG000
value
5.8
group Id
OG001
value
5.4
group Id
OG002
value
9.1
title
Composite^

denoms

counts
group Id
OG000
value
234
group Id
OG001
value
851
group Id
OG002
value
473
units
Participants

description

groups

description
Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN that initiated study drug on day 0 (during chemotherapy)
id
OG000
title
EP2006: Day 0 (During Chemotherapy)
description
Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN that initiated study drug on days 1-3 (per guidelines)
id
OG001
title
EP2006: Days 1-3 (Per Guidelines)
description
Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN that initiated study drug on day 4 or later
id
OG002
title
EP2006: Day 4 or Later

param Type

NUMBER

population Description

Evaluable sample by day of study drug initiation. As these are cycle-level analyses and since patients can be in more than one category over the course of the study, the sum of patients of all three categories may 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

Incidence of Outcomes by Day of Study Drug Initiation: Cycle Level

type

PRIMARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice