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NCT03252431 · OUTCOME

The Number of Participants With Grade 4 Neutropenia for Chemotherapy Cycle 1

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
The first of 4, 21-day chemotherapy cycles (average 3 weeks)

What was measured

The number of participants with grade 4 neutropenia for chemotherapy cycle 1. Grade 4 (severe) neutropenia was defined as ANC \<0.5 × 109/L within the first 12 days of chemotherapy.

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 Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
F-62723Not reportedNot reportedNot reportedNot reported
Neulasta23Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        23
denoms
  1. counts
    1. group Id
      OG000
      value
      197
    2. group Id
      OG001
      value
      196
    units
    Participants
description
The number of participants with grade 4 neutropenia for chemotherapy cycle 1. Grade 4 (severe) neutropenia was defined as ANC \<0.5 × 109/L within the first 12 days of chemotherapy.
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
COUNT_OF_PARTICIPANTS
population Description
ITT (Intent-to-Treat) population
reporting Status
POSTED
time Frame
The first of 4, 21-day chemotherapy cycles (average 3 weeks)
title
The Number of Participants With Grade 4 Neutropenia for Chemotherapy Cycle 1
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice