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NCT02872103 · OUTCOME

Number of Participants With Febrile Neutropenia (FN) 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

Febrile neutropenia is defined as a single oral temperature of ≥38.3°C (101°F) or a temperature of \>38.0°C (100.4°F) sustained for \>1 hour and ANC \< 0.5 x 10\^9/L

Analysis population: 3 subjects terminated early.

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 FN

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
F-6274Not reportedNot reportedNot reportedNot reported
Placebo10Not reportedNot reportedNot reportedNot reported

Subject without FN

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
F-62779Not reportedNot reportedNot reportedNot reported
Placebo29Not reportedNot reportedNot reportedNot reported
Cycle 2

Analysis denominator · Participants

GroupSource count
F-62783
Placebo38

Subjects with FN

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
F-6270Not reportedNot reportedNot reportedNot reported
Placebo1Not reportedNot reportedNot reportedNot reported

Subject without FN

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
F-62783Not reportedNot reportedNot reportedNot reported
Placebo37Not reportedNot reportedNot reportedNot reported
Cycle 3

Analysis denominator · Participants

GroupSource count
F-62782
Placebo37

Subjects with FN

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
F-6270Not reportedNot reportedNot reportedNot reported
Placebo0Not reportedNot reportedNot reportedNot reported

Subject without FN

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
F-62782Not reportedNot reportedNot reportedNot reported
Placebo37Not reportedNot reportedNot reportedNot reported
Cycle 4

Analysis denominator · Participants

GroupSource count
F-62782
Placebo37

Subjects with FN

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
F-6270Not reportedNot reportedNot reportedNot reported
Placebo0Not reportedNot reportedNot reportedNot reported

Subject without FN

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
F-62782Not reportedNot reportedNot reportedNot reported
Placebo37Not reportedNot reportedNot reportedNot reported
All cycles

Analysis denominator · Participants

GroupSource count
F-62783
Placebo39

Subjects with FN

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
F-6274Not reportedNot reportedNot reportedNot reported
Placebo11Not reportedNot reportedNot reportedNot reported

Subject without FN

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
F-62779Not reportedNot reportedNot reportedNot reported
Placebo28Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        10
      title
      Subjects with FN
    2. measurements
      1. group Id
        OG000
        value
        79
      2. group Id
        OG001
        value
        29
      title
      Subject without FN
    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
        0
      2. group Id
        OG001
        value
        1
      title
      Subjects with FN
    2. measurements
      1. group Id
        OG000
        value
        83
      2. group Id
        OG001
        value
        37
      title
      Subject without FN
    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
        0
      2. group Id
        OG001
        value
        0
      title
      Subjects with FN
    2. measurements
      1. group Id
        OG000
        value
        82
      2. group Id
        OG001
        value
        37
      title
      Subject without FN
    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
        0
      2. group Id
        OG001
        value
        0
      title
      Subjects with FN
    2. measurements
      1. group Id
        OG000
        value
        82
      2. group Id
        OG001
        value
        37
      title
      Subject without FN
    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
        4
      2. group Id
        OG001
        value
        11
      title
      Subjects with FN
    2. measurements
      1. group Id
        OG000
        value
        79
      2. group Id
        OG001
        value
        28
      title
      Subject without FN
    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
Febrile neutropenia is defined as a single oral temperature of ≥38.3°C (101°F) or a temperature of \>38.0°C (100.4°F) sustained for \>1 hour and ANC \< 0.5 x 10\^9/L
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
3 subjects terminated early.
reporting Status
POSTED
time Frame
4 chemotherapy cycles, about 12 weeks
title
Number of Participants With Febrile Neutropenia (FN) 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