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NCT02872103 · OUTCOME

Number of Participants With Grade 2, Grade 3, and Grade 4 Neutropenia for All Chemotherapy 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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
4 chemotherapy cycles, about 12 weeks

What was measured

The number of subjects with grade 2, 3 and 4 neutropenia will be recorded for all 4 chemotherapy cycles.

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 Neutropenia

yes

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
F-62758Not reportedNot reportedNot reportedNot reported
Placebo37Not reportedNot reportedNot reportedNot reported

no

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
F-62725Not reportedNot reportedNot reportedNot reported
Placebo2Not reportedNot reportedNot reportedNot reported
Grade 3 Neutropenia

yes

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
F-62771Not reportedNot reportedNot reportedNot reported
Placebo37Not reportedNot reportedNot reportedNot reported

no

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
F-62712Not reportedNot reportedNot reportedNot reported
Placebo2Not reportedNot reportedNot reportedNot reported
Grade 2 Neutropenia

yes

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
F-62777Not reportedNot reportedNot reportedNot reported
Placebo37Not reportedNot reportedNot reportedNot reported

no

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
F-6276Not reportedNot reportedNot reportedNot reported
Placebo2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        58
      2. group Id
        OG001
        value
        37
      title
      yes
    2. measurements
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        2
      title
      no
    title
    Grade 4 Neutropenia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        71
      2. group Id
        OG001
        value
        37
      title
      yes
    2. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        2
      title
      no
    title
    Grade 3 Neutropenia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        77
      2. group Id
        OG001
        value
        37
      title
      yes
    2. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        2
      title
      no
    title
    Grade 2 Neutropenia
denoms
  1. counts
    1. group Id
      OG000
      value
      83
    2. group Id
      OG001
      value
      39
    units
    Participants
description
The number of subjects with grade 2, 3 and 4 neutropenia will be recorded for all 4 chemotherapy cycles.
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
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
4 chemotherapy cycles, about 12 weeks
title
Number of Participants With Grade 2, Grade 3, and Grade 4 Neutropenia for All Chemotherapy Cycles.
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice