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NCT02872103 · OUTCOME

The Time in Days to ANC Recovery Post Nadir for Each Chemotherapy Cycle and Over All Cycles; Recovery Defined as an ANC ≥ 2.0 × 10^9/L After the Expected ANC Nadir.

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 time to ANC recovery post nadir for each patient, for each of their chemotherapy cycles will be recorded. Recovery for this protocol is defined as achieving an ANC ≥ 2.0 × 10\^9/L after the expected ANC nadir (expected nadir is typically 4-6 days post chemotherapy administration).

Analysis population: 3 Subjects terminated early (1 in F-627 arm, 2 in the placebo arm). In addition, 1 subject in placebo arm reached her Nadir(1.81) at Day 7 but the rest of ANC values are missing. Because the recovery information is not available, this subject was removed from the Time to ANC recovery analysis.

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
Placebo38
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
F-6272.11.08Not reportedNot reportedNot reported
Placebo4.02.07Not reportedNot reportedNot reported
Cycle 2

Analysis denominator · Participants

GroupSource count
F-62783
Placebo38
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
F-6271.61.35Not reportedNot reportedNot reported
Placebo2.01.37Not reportedNot reportedNot reported
Cycle 3

Analysis denominator · Participants

GroupSource count
F-62782
Placebo37
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
F-6271.61.34Not reportedNot reportedNot reported
Placebo1.71.79Not reportedNot reportedNot reported
Cycle 4

Analysis denominator · Participants

GroupSource count
F-62782
Placebo36
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
F-6271.91.39Not reportedNot reportedNot reported
Placebo1.51.73Not reportedNot reportedNot reported
All cycles

Analysis denominator · Participants

GroupSource count
F-62783
Placebo39
Values in days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
F-6271.80.94Not reportedNot reportedNot reported
Placebo2.41.20Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.08
        value
        2.1
      2. group Id
        OG001
        spread
        2.07
        value
        4.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        83
      2. group Id
        OG001
        value
        38
      units
      Participants
    title
    Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.35
        value
        1.6
      2. group Id
        OG001
        spread
        1.37
        value
        2.0
    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
        spread
        1.34
        value
        1.6
      2. group Id
        OG001
        spread
        1.79
        value
        1.7
    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
        spread
        1.39
        value
        1.9
      2. group Id
        OG001
        spread
        1.73
        value
        1.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        82
      2. group Id
        OG001
        value
        36
      units
      Participants
    title
    Cycle 4
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.94
        value
        1.8
      2. group Id
        OG001
        spread
        1.20
        value
        2.4
    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 time to ANC recovery post nadir for each patient, for each of their chemotherapy cycles will be recorded. Recovery for this protocol is defined as achieving an ANC ≥ 2.0 × 10\^9/L after the expected ANC nadir (expected nadir is typically 4-6 days post chemotherapy administration).
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
3 Subjects terminated early (1 in F-627 arm, 2 in the placebo arm). In addition, 1 subject in placebo arm reached her Nadir(1.81) at Day 7 but the rest of ANC values are missing. Because the recovery information is not available, this subject was removed from the Time to ANC recovery analysis.
reporting Status
POSTED
time Frame
4 chemotherapy cycles, about 12 weeks
title
The Time in Days to ANC Recovery Post Nadir for Each Chemotherapy Cycle and Over All Cycles; Recovery Defined as an ANC ≥ 2.0 × 10^9/L After the Expected ANC Nadir.
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice