NCT01459653 · OUTCOME

Number of Participants With All-cause Mortality by Any/no Grade 4 CIN and/or FN

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 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 shows number of patients that died in each group. CIN: chemotherapy-induced neutropenia; FN: febrile neutropenia

Analysis population: Evaluable sample by any/no grade 4 CIN/FN

Groups in this outcome

EP2006: Any Grade 4 CIN/FN

Cancer patients with any grade 4 CIN/FIN treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.

EP2006: No Grade 4 CIN/FN

Cancer patients with no grade 4 CIN/FIN 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

Group	Source count
EP2006: Any Grade 4 CIN/FN	221
EP2006: No Grade 4 CIN/FN	1226

Reported measurements

Source class 1

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
EP2006: Any Grade 4 CIN/FN	10	Not reported	Not reported	Not reported	Not reported
EP2006: No Grade 4 CIN/FN	46	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

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

ci Num Sides
TWO_SIDED
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.5977
statistical Method
Log Rank
tested Non Inferiority
false

Complete source fields

analyses

ci Num Sides
TWO_SIDED
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.5977
statistical Method
Log Rank
tested Non Inferiority
false

classes

categories
measurements
group Id
OG000
value
10
group Id
OG001
value
46

denoms

counts
group Id
OG000
value
221
group Id
OG001
value
1226
units
Participants

description

groups

description
Cancer patients with any grade 4 CIN/FIN treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
id
OG000
title
EP2006: Any Grade 4 CIN/FN
description
Cancer patients with no grade 4 CIN/FIN treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
id
OG001
title
EP2006: No Grade 4 CIN/FN

param Type

NUMBER

population Description

Evaluable sample by any/no grade 4 CIN/FN

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

Number of Participants With All-cause Mortality by Any/no Grade 4 CIN and/or FN

type

PRIMARY

unit Of Measure

participants

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

Preserved source evidence · Not medical advice