NCT02413008 · BASELINE

Baseline characteristics

A Clinical Trial to Assess the Safety of 0.005 % Estriol Vaginal Gel in Hormone Receptor-Positive Postmenopausal Women With Early Stage Breast Cancer in Treatment With Aromatase Inhibitor in the Adjuvant Setting · Source last updated 2019-08-05

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms

counts
group Id
BG000
value
50
group Id
BG001
value
11
group Id
BG002
value
61
units
Participants

groups

description
Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration estriol
id
BG000
title
0.005% Estriol Vaginal Gel
description
Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration Placebo
id
BG001
title
Placebo Vaginal Gel
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
<=18 years
measurements
group Id
BG000
value
46
group Id
BG001
value
9
group Id
BG002
value
55
title
Between 18 and 65 years
measurements
group Id
BG000
value
4
group Id
BG001
value
2
group Id
BG002
value
6
title
>=65 years
denoms
counts
group Id
BG000
value
50
group Id
BG001
value
11
group Id
BG002
value
61
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
7.6
value
58.9
group Id
BG001
spread
4.7
value
61.4
group Id
BG002
spread
7.1
value
59.3
denoms
counts
group Id
BG000
value
50
group Id
BG001
value
11
group Id
BG002
value
61
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
50
group Id
BG001
value
11
group Id
BG002
value
61
denoms
counts
group Id
BG000
value
50
group Id
BG001
value
11
group Id
BG002
value
61
units
Participants
title
Female
param Type
COUNT_OF_PARTICIPANTS
title
Sex/Gender, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG002
value
0
denoms
counts
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
units
Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
Race and Ethnicity were not collected from any participant.
title
Race and Ethnicity Not Collected
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
17
group Id
BG001
value
4
group Id
BG002
value
21
denoms
counts
group Id
BG000
value
50
group Id
BG001
value
11
group Id
BG002
value
61
units
Participants
title
Sweden
categories
measurements
group Id
BG000
value
33
group Id
BG001
value
7
group Id
BG002
value
40
denoms
counts
group Id
BG000
value
50
group Id
BG001
value
11
group Id
BG002
value
61
units
Participants
title
Spain
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants

Complete source fields

denoms

counts
group Id
BG000
value
50
group Id
BG001
value
11
group Id
BG002
value
61
units
Participants

groups

description
Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration estriol
id
BG000
title
0.005% Estriol Vaginal Gel
description
Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration Placebo
id
BG001
title
Placebo Vaginal Gel
description
Total of all reporting groups
id
BG002
title
Total

measures

classes
categories
measurements
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
title
<=18 years
measurements
group Id
BG000
value
46
group Id
BG001
value
9
group Id
BG002
value
55
title
Between 18 and 65 years
measurements
group Id
BG000
value
4
group Id
BG001
value
2
group Id
BG002
value
6
title
>=65 years
denoms
counts
group Id
BG000
value
50
group Id
BG001
value
11
group Id
BG002
value
61
units
Participants
param Type
COUNT_OF_PARTICIPANTS
title
Age, Categorical
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
spread
7.6
value
58.9
group Id
BG001
spread
4.7
value
61.4
group Id
BG002
spread
7.1
value
59.3
denoms
counts
group Id
BG000
value
50
group Id
BG001
value
11
group Id
BG002
value
61
units
Participants
dispersion Type
STANDARD_DEVIATION
param Type
MEAN
title
Age, Continuous
unit Of Measure
years
classes
categories
measurements
group Id
BG000
value
50
group Id
BG001
value
11
group Id
BG002
value
61
denoms
counts
group Id
BG000
value
50
group Id
BG001
value
11
group Id
BG002
value
61
units
Participants
title
Female
param Type
COUNT_OF_PARTICIPANTS
title
Sex/Gender, Customized
unit Of Measure
Participants
classes
categories
measurements
group Id
BG002
value
0
denoms
counts
group Id
BG000
value
0
group Id
BG001
value
0
group Id
BG002
value
0
units
Participants
param Type
COUNT_OF_PARTICIPANTS
population Description
Race and Ethnicity were not collected from any participant.
title
Race and Ethnicity Not Collected
unit Of Measure
Participants
classes
categories
measurements
group Id
BG000
value
17
group Id
BG001
value
4
group Id
BG002
value
21
denoms
counts
group Id
BG000
value
50
group Id
BG001
value
11
group Id
BG002
value
61
units
Participants
title
Sweden
categories
measurements
group Id
BG000
value
33
group Id
BG001
value
7
group Id
BG002
value
40
denoms
counts
group Id
BG000
value
50
group Id
BG001
value
11
group Id
BG002
value
61
units
Participants
title
Spain
param Type
NUMBER
title
Region of Enrollment
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice