Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02872103 · OUTCOME

The Duration in Days of Grade 4 (Severe) Neutropenia Observed in Chemotherapy Cycle 1 in Comparison to Placebo

Placebo-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy · Source last updated 2021-05-05

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
The first of 4, 21 Day Chemotherapy Cycles, an average of 3 weeks

What was measured

Subjects will be randomized to F-627 or Placebo at 2:1 ratio. About 24 hours after chemotherapy, subjects will either receive 20mg fixed dose F-627 or Placebo. The subject's absolute neutrophil count (ANC) will be monitored each day post chemotherapy administration until the ANC level exceeds 2.0x10\^9/L, then the value will be monitored every three days until the next chemotherapy cycle is entered. The duration of grade 4 neutropenia (ANC \<0.5x10\^9/L) in this cycle is the primary efficacy endpoint.

Groups in this outcome

F-627

F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.

Placebo

Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle; and F-627, 20 mg fixed dose pre-filled syringe administered Day 2 of each of the following 3 chemotherapy cycles.

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-62783
Placebo39

Reported measurements

Source class 1
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
F-6271.31.17Not reportedNot reportedNot reported
Placebo3.91.35Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.17
        value
        1.3
      2. group Id
        OG001
        spread
        1.35
        value
        3.9
denoms
  1. counts
    1. group Id
      OG000
      value
      83
    2. group Id
      OG001
      value
      39
    units
    Participants
description
Subjects will be randomized to F-627 or Placebo at 2:1 ratio. About 24 hours after chemotherapy, subjects will either receive 20mg fixed dose F-627 or Placebo. The subject's absolute neutrophil count (ANC) will be monitored each day post chemotherapy administration until the ANC level exceeds 2.0x10\^9/L, then the value will be monitored every three days until the next chemotherapy cycle is entered. The duration of grade 4 neutropenia (ANC \<0.5x10\^9/L) in this cycle is the primary efficacy endpoint.
dispersion Type
Standard Deviation
groups
  1. description
    F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.
    id
    OG000
    title
    F-627
  2. description
    Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle; and F-627, 20 mg fixed dose pre-filled syringe administered Day 2 of each of the following 3 chemotherapy cycles.
    id
    OG001
    title
    Placebo
param Type
MEAN
reporting Status
POSTED
time Frame
The first of 4, 21 Day Chemotherapy Cycles, an average of 3 weeks
title
The Duration in Days of Grade 4 (Severe) Neutropenia Observed in Chemotherapy Cycle 1 in Comparison to Placebo
type
PRIMARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice