NCT02872103 · BASELINE

Baseline characteristics

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.

denoms

counts
group Id
BG000
value
83
group Id
BG001
value
39
group Id
BG002
value
122
units
Participants

groups

description
F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.
id
BG000
title
F-627
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
BG001
title
Placebo
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
9.25
value
50.8
group Id
BG001
spread
9.00
value
51.5
group Id
BG002
spread
9.14
value
51.0
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
83
group Id
BG001
value
39
group Id
BG002
value
122
title
Female
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
Hispanic or Latino
measurements
group Id
BG000
value
82
group Id
BG001
value
38
group Id
BG002
value
120
title
Not Hispanic or Latino
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
American Indian or Alaska Native
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Black or African American
measurements
group Id
BG000
value
82
group Id
BG001
value
39
group Id
BG002
value
121
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
More than one race
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
United States
categories
measurements
group Id
BG000
value
46
group Id
BG001
value
22
group Id
BG002
value
68
title
Ukraine
categories
measurements
group Id
BG000
value
32
group Id
BG001
value
16
group Id
BG002
value
48
title
Russia
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
1
group Id
BG002
value
5
title
Hungary
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
37
group Id
BG001
value
15
group Id
BG002
value
52
title
Childbearing potential
measurements
group Id
BG000
value
42
group Id
BG001
value
23
group Id
BG002
value
65
title
Non-childbearing potential - Post-menopausal
measurements
group Id
BG000
value
4
group Id
BG001
value
1
group Id
BG002
value
5
title
Non-childbearing potential - Surgically sterile
param Type
COUNT_OF_PARTICIPANTS
title
Reproductive Status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
5.36
value
26.2
group Id
BG001
spread
6.22
value
27.4
group Id
BG002
spread
5.65
value
26.6
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
BMI (kg/m^2)
unit Of Measure
kg/m^2
classes
categories
measurements
group Id
BG000
value
46
group Id
BG001
value
27
group Id
BG002
value
73
title
Grade 0
measurements
group Id
BG000
value
37
group Id
BG001
value
12
group Id
BG002
value
49
title
Grade 1
description
The Eastern Cooperative Oncology Group (ECOG) performance status is a scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. Grade 0: fully active, able to carry on all pre-disease performance without restriction Grade 1: restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work
param Type
COUNT_OF_PARTICIPANTS
title
Baseline ECOG
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
43
group Id
BG001
value
21
group Id
BG002
value
64
title
Stage II
measurements
group Id
BG000
value
22
group Id
BG001
value
12
group Id
BG002
value
34
title
Stage III
measurements
group Id
BG000
value
18
group Id
BG001
value
6
group Id
BG002
value
24
title
Stage IV
description
Doctors combine the tumor, node, metastasis results and other factors specific to cancer to determine the stage of cancer for each person. Most types of cancer have four stages: stages I to IV. Stage IV is considered a worse outcome than Stage I.
param Type
COUNT_OF_PARTICIPANTS
title
Cancer Stage at Screening
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
572.21
value
224.5
group Id
BG001
spread
1337.99
value
445.9
group Id
BG002
spread
888.93
value
294.6
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Days from Diagnosis
unit Of Measure
days

Complete source fields

denoms

counts
group Id
BG000
value
83
group Id
BG001
value
39
group Id
BG002
value
122
units
Participants

groups

description
F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles.
id
BG000
title
F-627
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
BG001
title
Placebo
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
spread
9.25
value
50.8
group Id
BG001
spread
9.00
value
51.5
group Id
BG002
spread
9.14
value
51.0
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
83
group Id
BG001
value
39
group Id
BG002
value
122
title
Female
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Male
param Type
COUNT_OF_PARTICIPANTS
title
Sex: Female, Male
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
1
group Id
BG002
value
2
title
Hispanic or Latino
measurements
group Id
BG000
value
82
group Id
BG001
value
38
group Id
BG002
value
120
title
Not Hispanic or Latino
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Ethnicity (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
American Indian or Alaska Native
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Asian
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Native Hawaiian or Other Pacific Islander
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
Black or African American
measurements
group Id
BG000
value
82
group Id
BG001
value
39
group Id
BG002
value
121
title
White
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
More than one race
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
Unknown or Not Reported
param Type
COUNT_OF_PARTICIPANTS
title
Race (NIH/OMB)
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
1
group Id
BG001
value
0
group Id
BG002
value
1
title
United States
categories
measurements
group Id
BG000
value
46
group Id
BG001
value
22
group Id
BG002
value
68
title
Ukraine
categories
measurements
group Id
BG000
value
32
group Id
BG001
value
16
group Id
BG002
value
48
title
Russia
categories
measurements
group Id
BG000
value
4
group Id
BG001
value
1
group Id
BG002
value
5
title
Hungary
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants
classes
categories
measurements
group Id
BG000
value
37
group Id
BG001
value
15
group Id
BG002
value
52
title
Childbearing potential
measurements
group Id
BG000
value
42
group Id
BG001
value
23
group Id
BG002
value
65
title
Non-childbearing potential - Post-menopausal
measurements
group Id
BG000
value
4
group Id
BG001
value
1
group Id
BG002
value
5
title
Non-childbearing potential - Surgically sterile
param Type
COUNT_OF_PARTICIPANTS
title
Reproductive Status
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
5.36
value
26.2
group Id
BG001
spread
6.22
value
27.4
group Id
BG002
spread
5.65
value
26.6
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
BMI (kg/m^2)
unit Of Measure
kg/m^2
classes
categories
measurements
group Id
BG000
value
46
group Id
BG001
value
27
group Id
BG002
value
73
title
Grade 0
measurements
group Id
BG000
value
37
group Id
BG001
value
12
group Id
BG002
value
49
title
Grade 1
description
The Eastern Cooperative Oncology Group (ECOG) performance status is a scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. Grade 0: fully active, able to carry on all pre-disease performance without restriction Grade 1: restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work
param Type
COUNT_OF_PARTICIPANTS
title
Baseline ECOG
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
43
group Id
BG001
value
21
group Id
BG002
value
64
title
Stage II
measurements
group Id
BG000
value
22
group Id
BG001
value
12
group Id
BG002
value
34
title
Stage III
measurements
group Id
BG000
value
18
group Id
BG001
value
6
group Id
BG002
value
24
title
Stage IV
description
Doctors combine the tumor, node, metastasis results and other factors specific to cancer to determine the stage of cancer for each person. Most types of cancer have four stages: stages I to IV. Stage IV is considered a worse outcome than Stage I.
param Type
COUNT_OF_PARTICIPANTS
title
Cancer Stage at Screening
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
572.21
value
224.5
group Id
BG001
spread
1337.99
value
445.9
group Id
BG002
spread
888.93
value
294.6
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Days from Diagnosis
unit Of Measure
days

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

Preserved source evidence · Not medical advice