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NCT01915303 · OUTCOME

Number of Participants With Shift From Mild to Severe in Clinical Signs of Hypercortisolism

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 1, 2, 4, every 4 or 5 weeks during core, every 8 weeks during extension

What was measured

Facial rubor, hirsutism, striae, and supraclavicular and dorsal fat pad were assessed. Two photographs, one frontal and one lateral from the shoulders up will be taken to assess facial plethora, supraclavicular and dorsal fat pads. Two photographs, frontal and dorsal of the trunk with patient in standing position will be taken to assess striae, and hirsutism. The photographs must be assessed by a qualified physician at the site. Improvement=decrease in severity of symptom since baseline

Analysis population: Full analysis set

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 4 Facial rubor baseline n=17

Analysis denominator · Participants

Group	Source count
All Patients	17

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
All Patients	1	Not reported	Not reported	Not reported	Not reported

Core Week 35 Facial rubor baseline n=17

Analysis denominator · Participants

Group	Source count
All Patients	17

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 43 Facial rubor baseline n=17

Analysis denominator · Participants

Group	Source count
All Patients	17

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 Facial rubor baseline n=17

Analysis denominator · Participants

Group	Source count
All Patients	17

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 67 Facial rubor baseline n=17

Analysis denominator · Participants

Group	Source count
All Patients	17

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 83 Facial rubor baseline n=17

Analysis denominator · Participants

Group	Source count
All Patients	17

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 Facial rubor baseline n=17

Analysis denominator · Participants

Group	Source count
All Patients	17

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 99 Facial rubor baseline n=17

Analysis denominator · Participants

Group	Source count
All Patients	17

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 Facial rubor baseline n=17

Analysis denominator · Participants

Group	Source count
All Patients	17

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 115 Facial rubor baseline n=17

Analysis denominator · Participants

Group	Source count
All Patients	17

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 123 Facial rubor baseline n=17

Analysis denominator · Participants

Group	Source count
All Patients	17

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
All Patients	1	Not reported	Not reported	Not reported	Not reported

Core Week 1 Hirsutism baseline 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

Core Week 2 Hirsutism baseline 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 59 Striae baseline 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 99 Striae baseline 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 Striae baseline 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 115 Striae baseline 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 123 Striae baseline 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 99 Supraclavicular fat pad BL n=17

Analysis denominator · Participants

Group	Source count
All Patients	17

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 Supraclavicular fat pad BL n=17

Analysis denominator · Participants

Group	Source count
All Patients	17

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
1
denoms
counts
group Id
OG000
value
17
units
Participants
title
Core Week 4 Facial rubor baseline n=17
categories
measurements
group Id
OG000
value
1
denoms
counts
group Id
OG000
value
17
units
Participants
title
Core Week 35 Facial rubor baseline n=17
categories
measurements
group Id
OG000
value
1
denoms
counts
group Id
OG000
value
17
units
Participants
title
Ext Week 43 Facial rubor baseline n=17
categories
measurements
group Id
OG000
value
1
denoms
counts
group Id
OG000
value
17
units
Participants
title
Ext Week 59 Facial rubor baseline n=17
categories
measurements
group Id
OG000
value
1
denoms
counts
group Id
OG000
value
17
units
Participants
title
Ext Week 67 Facial rubor baseline n=17
categories
measurements
group Id
OG000
value
1
denoms
counts
group Id
OG000
value
17
units
Participants
title
Ext Week 83 Facial rubor baseline n=17
categories
measurements
group Id
OG000
value
1
denoms
counts
group Id
OG000
value
17
units
Participants
title
Ext Week 91 Facial rubor baseline n=17
categories
measurements
group Id
OG000
value
1
denoms
counts
group Id
OG000
value
17
units
Participants
title
Ext Week 99 Facial rubor baseline n=17
categories
measurements
group Id
OG000
value
1
denoms
counts
group Id
OG000
value
17
units
Participants
title
Ext Week 107 Facial rubor baseline n=17
categories
measurements
group Id
OG000
value
1
denoms
counts
group Id
OG000
value
17
units
Participants
title
Ext Week 115 Facial rubor baseline n=17
categories
measurements
group Id
OG000
value
1
denoms
counts
group Id
OG000
value
17
units
Participants
title
Ext Week 123 Facial rubor baseline n=17
categories
measurements
group Id
OG000
value
1
denoms
counts
group Id
OG000
value
12
units
Participants
title
Core Week 1 Hirsutism baseline n=12

denoms

counts
group Id
OG000
value
68
units
Participants

description

Facial rubor, hirsutism, striae, and supraclavicular and dorsal fat pad were assessed. Two photographs, one frontal and one lateral from the shoulders up will be taken to assess facial plethora, supraclavicular and dorsal fat pads. Two photographs, frontal and dorsal of the trunk with patient in standing position will be taken to assess striae, and hirsutism. The photographs must be 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

reporting Status

POSTED

time Frame

Baseline, weeks 1, 2, 4, every 4 or 5 weeks during core, every 8 weeks during extension

title

Number of Participants With Shift From Mild to Severe in Clinical Signs of Hypercortisolism

type

SECONDARY

unit Of Measure

participants

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

Preserved source evidence · Not medical advice