Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02872103 · OUTCOME

The Depth of the ANC Nadir 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
MEAN
Unit
cells/10^9/L
Interval / dispersion
Standard Deviation
Time frame
4 chemotherapy cycles, about 12 weeks

What was measured

The depth of ANC nadir for each cycle is the minimal ANC value (× 10\^9/L ) for a patient in each chemotherapy cycle

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
Values in cells/10^9/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
F-6270.71.16Not reportedNot reportedNot reported
Placebo0.20.57Not reportedNot reportedNot reported
Cycle 2

Analysis denominator · Participants

GroupSource count
F-62783
Placebo38
Values in cells/10^9/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
F-6272.01.71Not reportedNot reportedNot reported
Placebo1.61.71Not reportedNot reportedNot reported
Cycle 3

Analysis denominator · Participants

GroupSource count
F-62782
Placebo37
Values in cells/10^9/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
F-6271.71.58Not reportedNot reportedNot reported
Placebo1.81.63Not reportedNot reportedNot reported
Cycle 4

Analysis denominator · Participants

GroupSource count
F-62782
Placebo37
Values in cells/10^9/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
F-6271.71.45Not reportedNot reportedNot reported
Placebo2.32.01Not reportedNot reportedNot reported
All cycles

Analysis denominator · Participants

GroupSource count
F-62783
Placebo39
Values in cells/10^9/L · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
F-6271.51.20Not reportedNot reportedNot reported
Placebo1.41.23Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.16
        value
        0.7
      2. group Id
        OG001
        spread
        0.57
        value
        0.2
    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
        spread
        1.71
        value
        2.0
      2. group Id
        OG001
        spread
        1.71
        value
        1.6
    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
        1.58
        value
        1.7
      2. group Id
        OG001
        spread
        1.63
        value
        1.8
    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
        1.45
        value
        1.7
      2. group Id
        OG001
        spread
        2.01
        value
        2.3
    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
        spread
        1.20
        value
        1.5
      2. group Id
        OG001
        spread
        1.23
        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 depth of ANC nadir for each cycle is the minimal ANC value (× 10\^9/L ) for a patient in each chemotherapy cycle
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.
reporting Status
POSTED
time Frame
4 chemotherapy cycles, about 12 weeks
title
The Depth of the ANC Nadir for Each Chemotherapy Cycle and Over All Cycles.
type
SECONDARY
unit Of Measure
cells/10^9/L

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

Preserved source evidence · Not medical advice