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NCT02872103 · OUTCOME

The Duration in Days of Grade 2 (Mild), Grade 3 (Moderate) and 4 (Severe) Neutropenia Over All Cycles.

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
4 chemotherapy cycles, about 12 weeks

What was measured

The duration in days of mild, moderate and severe neutropenia will be recorded for 4 chemotherapy cycles. Grade 2 neutropenia is when a patient's ANC\<1.5x10\^9/L, Grade 3 neutropenia is when a patient's ANC\<1.0x10\^9/L, and Grade 4 neutropenia is when a patient's ANC \<0.5x10\^9/L.

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

Grade 4
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
F-6270.50.62Not reportedNot reportedNot reported
Placebo1.41.32Not reportedNot reportedNot reported
Grade 3
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
F-6271.21.08Not reportedNot reportedNot reported
Placebo1.91.46Not reportedNot reportedNot reported
Grade 2
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
F-6271.81.24Not reportedNot reportedNot reported
Placebo2.71.71Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.62
        value
        0.5
      2. group Id
        OG001
        spread
        1.32
        value
        1.4
    title
    Grade 4
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.08
        value
        1.2
      2. group Id
        OG001
        spread
        1.46
        value
        1.9
    title
    Grade 3
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.24
        value
        1.8
      2. group Id
        OG001
        spread
        1.71
        value
        2.7
    title
    Grade 2
denoms
  1. counts
    1. group Id
      OG000
      value
      83
    2. group Id
      OG001
      value
      39
    units
    Participants
description
The duration in days of mild, moderate and severe neutropenia will be recorded for 4 chemotherapy cycles. Grade 2 neutropenia is when a patient's ANC\<1.5x10\^9/L, Grade 3 neutropenia is when a patient's ANC\<1.0x10\^9/L, and Grade 4 neutropenia is when a patient's ANC \<0.5x10\^9/L.
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
4 chemotherapy cycles, about 12 weeks
title
The Duration in Days of Grade 2 (Mild), Grade 3 (Moderate) and 4 (Severe) Neutropenia Over All Cycles.
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice