NCT03252431 · OUTCOME

Duration in Days of Use of Intravenous Antibiotic

Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy · Source last updated 2023-07-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

What was measured

The duration of use of IV antibiotics was defined as the number of days in which IV antibiotics were administered

Analysis population: ITT (Intent-to-Treat) population

F-627, 20 mg fixed dose pre-filled syringe, administered on Day 2 of each of 4 chemotherapy cycles. F-627: single dose pre-filled syringe

6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles Neulasta: single dose pre-filled syringe

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
F-627	197
Neulasta	196

Source class 1

Values in days · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
F-627	0.3	1.36	Not reported	Not reported	Not reported
Neulasta	0.1	0.70	Not reported	Not reported	Not reported

Complete source fields

classes

denoms

description

The duration of use of IV antibiotics was defined as the number of days in which IV antibiotics were administered

dispersion Type

Standard Deviation

groups

param Type

MEAN

population Description

ITT (Intent-to-Treat) population

reporting Status

POSTED

time Frame

across all 4 chemotherapy cycles (average 84 days)

title

Duration in Days of Use of Intravenous Antibiotic

type

SECONDARY

unit Of Measure

days

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice