Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02872103 · OUTCOME

Number of Participants With Infections for Each Chemotherapy Cycle and 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
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 infections for each arm of the study will be recorded for each and all 4 chemotherapy cycles.

Analysis population: Some subjects terminated earlier

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

Cycle 1

Analysis denominator · Participants

GroupSource count
F-62783
Placebo39

Subjects with infection

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
F-6272Not reportedNot reportedNot reportedNot reported
Placebo3Not reportedNot reportedNot reportedNot reported

Subjects without infection

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
F-62781Not reportedNot reportedNot reportedNot reported
Placebo36Not reportedNot reportedNot reportedNot reported
Cycle 2

Analysis denominator · Participants

GroupSource count
F-62783
Placebo38

Subjects with infection

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
F-6271Not reportedNot reportedNot reportedNot reported
Placebo2Not reportedNot reportedNot reportedNot reported

Subjects without infection

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
F-62782Not reportedNot reportedNot reportedNot reported
Placebo36Not reportedNot reportedNot reportedNot reported
Cycle 3

Analysis denominator · Participants

GroupSource count
F-62782
Placebo37

Subjects with infection

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
F-6275Not reportedNot reportedNot reportedNot reported
Placebo3Not reportedNot reportedNot reportedNot reported

Subjects without infection

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
F-62777Not reportedNot reportedNot reportedNot reported
Placebo34Not reportedNot reportedNot reportedNot reported
Cycle 4

Analysis denominator · Participants

GroupSource count
F-62782
Placebo37

Subjects with infection

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
F-6271Not reportedNot reportedNot reportedNot reported
Placebo0Not reportedNot reportedNot reportedNot reported

Subjects without infection

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
F-62781Not reportedNot reportedNot reportedNot reported
Placebo37Not reportedNot reportedNot reportedNot reported
All cycles

Analysis denominator · Participants

GroupSource count
F-62783
Placebo39

Subjects with infection

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
F-6279Not reportedNot reportedNot reportedNot reported
Placebo8Not reportedNot reportedNot reportedNot reported

Subjects without infection

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
F-62774Not reportedNot reportedNot reportedNot reported
Placebo31Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      title
      Subjects with infection
    2. measurements
      1. group Id
        OG000
        value
        81
      2. group Id
        OG001
        value
        36
      title
      Subjects without infection
    denoms
    1. counts
      1. group Id
        OG000
        value
        83
      2. group Id
        OG001
        value
        39
      units
      Participants
    title
    Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      title
      Subjects with infection
    2. measurements
      1. group Id
        OG000
        value
        82
      2. group Id
        OG001
        value
        36
      title
      Subjects without infection
    denoms
    1. counts
      1. group Id
        OG000
        value
        83
      2. group Id
        OG001
        value
        38
      units
      Participants
    title
    Cycle 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        3
      title
      Subjects with infection
    2. measurements
      1. group Id
        OG000
        value
        77
      2. group Id
        OG001
        value
        34
      title
      Subjects without infection
    denoms
    1. counts
      1. group Id
        OG000
        value
        82
      2. group Id
        OG001
        value
        37
      units
      Participants
    title
    Cycle 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      title
      Subjects with infection
    2. measurements
      1. group Id
        OG000
        value
        81
      2. group Id
        OG001
        value
        37
      title
      Subjects without infection
    denoms
    1. counts
      1. group Id
        OG000
        value
        82
      2. group Id
        OG001
        value
        37
      units
      Participants
    title
    Cycle 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        8
      title
      Subjects with infection
    2. measurements
      1. group Id
        OG000
        value
        74
      2. group Id
        OG001
        value
        31
      title
      Subjects without infection
    denoms
    1. counts
      1. group Id
        OG000
        value
        83
      2. group Id
        OG001
        value
        39
      units
      Participants
    title
    All cycles
denoms
  1. counts
    1. group Id
      OG000
      value
      83
    2. group Id
      OG001
      value
      39
    units
    Participants
description
The number of subjects with infections for each arm of the study will be recorded for each and 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
population Description
Some subjects terminated earlier
reporting Status
POSTED
time Frame
4 chemotherapy cycles, about 12 weeks
title
Number of Participants With Infections for Each Chemotherapy Cycle and Over All Cycles.
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice