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NCT02872103 · OUTCOME

The Duration in Days of Grade 4 (Severe) Neutropenia (ANC < 0.5 × 10^9/L) for Chemotherapy Cycles 2, 3, and 4, 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
MEAN
Unit
days
Interval / dispersion
Standard Deviation
Time frame
Over all 4 cycles, about 12 weeks

What was measured

The duration of severe neutropenia will be measured for each patient during chemotherapy cycle 2-4 and over all cycles. Each chemotherapy is expected to last 21 days.

Analysis population: Missing ANC data. No multiple imputation

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 2

Analysis denominator · Participants

GroupSource count
F-62775
Placebo36
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
F-6270.30.76Not reportedNot reportedNot reported
Placebo0.81.20Not reportedNot reportedNot reported
Cycle 3

Analysis denominator · Participants

GroupSource count
F-62772
Placebo32
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
F-6270.30.84Not reportedNot reportedNot reported
Placebo0.51.19Not reportedNot reportedNot reported
Cycle 4

Analysis denominator · Participants

GroupSource count
F-62773
Placebo29
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
F-6270.20.62Not reportedNot reportedNot reported
Placebo0.71.39Not reportedNot reportedNot reported
All cycles

Analysis denominator · Participants

GroupSource count
F-62783
Placebo39
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
F-6270.50.62Not reportedNot reportedNot reported
Placebo1.41.32Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.76
        value
        0.3
      2. group Id
        OG001
        spread
        1.20
        value
        0.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        75
      2. group Id
        OG001
        value
        36
      units
      Participants
    title
    Cycle 2
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.84
        value
        0.3
      2. group Id
        OG001
        spread
        1.19
        value
        0.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        72
      2. group Id
        OG001
        value
        32
      units
      Participants
    title
    Cycle 3
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.62
        value
        0.2
      2. group Id
        OG001
        spread
        1.39
        value
        0.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        73
      2. group Id
        OG001
        value
        29
      units
      Participants
    title
    Cycle 4
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.62
        value
        0.5
      2. group Id
        OG001
        spread
        1.32
        value
        1.4
    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 duration of severe neutropenia will be measured for each patient during chemotherapy cycle 2-4 and over all cycles. Each chemotherapy is expected to last 21 days.
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
population Description
Missing ANC data. No multiple imputation
reporting Status
POSTED
time Frame
Over all 4 cycles, about 12 weeks
title
The Duration in Days of Grade 4 (Severe) Neutropenia (ANC < 0.5 × 10^9/L) for Chemotherapy Cycles 2, 3, and 4, and Over All Cycles.
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice