Skip to content
← Full study record

NCT03252431 · OUTCOME

Duration in Days of Hospitalization

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.

Measure
MEAN
Unit
days
Interval / dispersion
Standard Deviation
Time frame
across all 4 chemotherapy cycles (average 84 days)

What was measured

The duration in days of patients been hospitalized for febrile neutropenia (FN) or any infection. Febrile neutropenia is defined as a single oral temperature of ≥38.3°C (101°F) or a temperature of \>38.0°C (100.4°F) sustained for \>1 hour and ANC \<0.5 x 10\^9/L on the same day.

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

Groups in this outcome

F-627

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

Neulasta

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

GroupSource count
F-627197
Neulasta196

Reported measurements

Source class 1
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
F-6270.10.78Not reportedNot reportedNot reported
Neulasta00.57Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.78
        value
        0.1
      2. group Id
        OG001
        spread
        0.57
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      197
    2. group Id
      OG001
      value
      196
    units
    Participants
description
The duration in days of patients been hospitalized for febrile neutropenia (FN) or any infection. Febrile neutropenia is defined as a single oral temperature of ≥38.3°C (101°F) or a temperature of \>38.0°C (100.4°F) sustained for \>1 hour and ANC \<0.5 x 10\^9/L on the same day.
dispersion Type
Standard Deviation
groups
  1. description
    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
    id
    OG000
    title
    F-627
  2. description
    6 mg fixed dose Neulasta®, administered on Day 2 of each of 4 chemotherapy cycles Neulasta: single dose pre-filled syringe
    id
    OG001
    title
    Neulasta
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 Hospitalization
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice