Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Striae
Study of the Efficacy and Safety of Pasireotide s.c. +/- Cabergoline in Patients With Cushing's Disease · Source last updated 2020-09-18
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Baseline, weeks 2, 4, every 4 or 5 weeks during core, every 16 weeks during extension
What was measured
Clinical symptoms include: facial rubor, hirsutism, striae, and supraclavicular and dorsal fat pad. Two photographs, one frontal and one lateral from the shoulders up were taken to assess facial plethora, supraclavicular and dorsal fat pads. Two photographs, frontal and dorsal of the trunk with patient in standing position were taken to assess striae, and hirsutism. The photographs were assessed by a qualified physician at the site. Improvement=decrease in severity of symptom since baseline
Analysis population: Full analysis set. The data beyond Week 139 should be interpreted with caution given that small number of subjects were monitored
Groups in this outcome
All Patients
Pasireotide montherapy (0.6 mg bid to 0.9 mg bid) was administered until the biochemical control was achieved and if not achieved, a combination was administered: pasireotide (0.9 mg bid) + cabergoline (0.5 QD to 1 mg QD). Patients were able to add cabergoline at anytime during core and extension
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
All Patients
68
Reported measurements
Core Week 1 n=40
Analysis denominator · Participants
Group
Source count
All Patients
40
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
5
Not reported
Not reported
Not reported
Not reported
Core Week 2 n-37
Analysis denominator · Participants
Group
Source count
All Patients
37
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
2
Not reported
Not reported
Not reported
Not reported
Core Week 4 n=38
Analysis denominator · Participants
Group
Source count
All Patients
38
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
5
Not reported
Not reported
Not reported
Not reported
Core Week 8 n=37
Analysis denominator · Participants
Group
Source count
All Patients
37
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
8
Not reported
Not reported
Not reported
Not reported
Core Week 13 n=32
Analysis denominator · Participants
Group
Source count
All Patients
32
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
7
Not reported
Not reported
Not reported
Not reported
Core Week 17 n=32
Analysis denominator · Participants
Group
Source count
All Patients
32
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
7
Not reported
Not reported
Not reported
Not reported
Core Week 22 n=28
Analysis denominator · Participants
Group
Source count
All Patients
28
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
7
Not reported
Not reported
Not reported
Not reported
Core Week 26 n=31
Analysis denominator · Participants
Group
Source count
All Patients
31
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
9
Not reported
Not reported
Not reported
Not reported
Core Week 31 n=32
Analysis denominator · Participants
Group
Source count
All Patients
32
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
12
Not reported
Not reported
Not reported
Not reported
Core Week 35 n=26
Analysis denominator · Participants
Group
Source count
All Patients
26
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
8
Not reported
Not reported
Not reported
Not reported
Ext Week 43 n11=
Analysis denominator · Participants
Group
Source count
All Patients
11
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Ext Week 59 n=11
Analysis denominator · Participants
Group
Source count
All Patients
11
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Ext Week 75 n=12
Analysis denominator · Participants
Group
Source count
All Patients
12
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Ext Week 91 n=10
Analysis denominator · Participants
Group
Source count
All Patients
10
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Ext Week 107 n=9
Analysis denominator · Participants
Group
Source count
All Patients
9
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
0
Not reported
Not reported
Not reported
Not reported
Ext Week 123 n=10
Analysis denominator · Participants
Group
Source count
All Patients
10
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
0
Not reported
Not reported
Not reported
Not reported
Ext Week 139 n=7
Analysis denominator · Participants
Group
Source count
All Patients
7
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
0
Not reported
Not reported
Not reported
Not reported
Ext Week 155 n=4
Analysis denominator · Participants
Group
Source count
All Patients
4
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Ext Week 171 n=3
Analysis denominator · Participants
Group
Source count
All Patients
3
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
0
Not reported
Not reported
Not reported
Not reported
Ext Week 187 n=3
Analysis denominator · Participants
Group
Source count
All Patients
3
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
0
Not reported
Not reported
Not reported
Not reported
Ext Week 203 n=4
Analysis denominator · Participants
Group
Source count
All Patients
4
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Ext Week 219 n=2
Analysis denominator · Participants
Group
Source count
All Patients
2
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
0
Not reported
Not reported
Not reported
Not reported
Ext Week 235 n=3
Analysis denominator · Participants
Group
Source count
All Patients
3
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Ext Week 251 n=1
Analysis denominator · Participants
Group
Source count
All Patients
1
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
0
Not reported
Not reported
Not reported
Not reported
Ext Week 267 n=1
Analysis denominator · Participants
Group
Source count
All Patients
1
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
All Patients
1
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
5
denoms
counts
group Id
OG000
value
40
units
Participants
title
Core Week 1 n=40
categories
measurements
group Id
OG000
value
2
denoms
counts
group Id
OG000
value
37
units
Participants
title
Core Week 2 n-37
categories
measurements
group Id
OG000
value
5
denoms
counts
group Id
OG000
value
38
units
Participants
title
Core Week 4 n=38
categories
measurements
group Id
OG000
value
8
denoms
counts
group Id
OG000
value
37
units
Participants
title
Core Week 8 n=37
categories
measurements
group Id
OG000
value
7
denoms
counts
group Id
OG000
value
32
units
Participants
title
Core Week 13 n=32
categories
measurements
group Id
OG000
value
7
denoms
counts
group Id
OG000
value
32
units
Participants
title
Core Week 17 n=32
categories
measurements
group Id
OG000
value
7
denoms
counts
group Id
OG000
value
28
units
Participants
title
Core Week 22 n=28
categories
measurements
group Id
OG000
value
9
denoms
counts
group Id
OG000
value
31
units
Participants
title
Core Week 26 n=31
categories
measurements
group Id
OG000
value
12
denoms
counts
group Id
OG000
value
32
units
Participants
title
Core Week 31 n=32
categories
measurements
group Id
OG000
value
8
denoms
counts
group Id
OG000
value
26
units
Participants
title
Core Week 35 n=26
categories
measurements
group Id
OG000
value
1
denoms
counts
group Id
OG000
value
11
units
Participants
title
Ext Week 43 n11=
categories
measurements
group Id
OG000
value
1
denoms
counts
group Id
OG000
value
11
units
Participants
title
Ext Week 59 n=11
denoms
counts
group Id
OG000
value
68
units
Participants
description
Clinical symptoms include: facial rubor, hirsutism, striae, and supraclavicular and dorsal fat pad. Two photographs, one frontal and one lateral from the shoulders up were taken to assess facial plethora, supraclavicular and dorsal fat pads. Two photographs, frontal and dorsal of the trunk with patient in standing position were taken to assess striae, and hirsutism. The photographs were assessed by a qualified physician at the site. Improvement=decrease in severity of symptom since baseline
groups
description
Pasireotide montherapy (0.6 mg bid to 0.9 mg bid) was administered until the biochemical control was achieved and if not achieved, a combination was administered: pasireotide (0.9 mg bid) + cabergoline (0.5 QD to 1 mg QD). Patients were able to add cabergoline at anytime during core and extension
id
OG000
title
All Patients
param Type
NUMBER
population Description
Full analysis set. The data beyond Week 139 should be interpreted with caution given that small number of subjects were monitored
reporting Status
POSTED
time Frame
Baseline, weeks 2, 4, every 4 or 5 weeks during core, every 16 weeks during extension
title
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Striae
Triangle