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NCT01915303 · OUTCOME

Mean Urinary Free Cortisol (mUFC) at Scheduled Visits

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: MEAN
Unit: nmol/24h
Interval / dispersion: Standard Deviation
Time frame: Baseline, weeks 2, 4, every 4 or 5 weeks during core, every 8 weeks during extension

What was measured

Mean value of mUFC at each scheduled visit was determined from two 24-hour urine collections collected on two consecutive days that occurred before the visit when UFC was measured.

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

Baseline

Analysis denominator · Participants

Group	Source count
All Patients	68

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	501.6	488.66	Not reported	Not reported	Not reported

Core Week 2 n-8

Analysis denominator · Participants

Group	Source count
All Patients	8

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	217.0	100.69	Not reported	Not reported	Not reported

Core Week 4 n=59

Analysis denominator · Participants

Group	Source count
All Patients	59

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	242.1	203.47	Not reported	Not reported	Not reported

Core Week 8 n=58

Analysis denominator · Participants

Group	Source count
All Patients	58

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	230.0	195.21	Not reported	Not reported	Not reported

Core Week 13 n=51

Analysis denominator · Participants

Group	Source count
All Patients	51

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	231.0	240.98	Not reported	Not reported	Not reported

Core Week 17 n=57

Analysis denominator · Participants

Group	Source count
All Patients	57

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	310.3	429.64	Not reported	Not reported	Not reported

Core Week 22 n=50

Analysis denominator · Participants

Group	Source count
All Patients	50

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	214.0	202.80	Not reported	Not reported	Not reported

Core Week 26 n=54

Analysis denominator · Participants

Group	Source count
All Patients	54

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	211.6	173.58	Not reported	Not reported	Not reported

Core Week 31 n=46

Analysis denominator · Participants

Group	Source count
All Patients	46

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	154.3	104.16	Not reported	Not reported	Not reported

Core Week 35 n=45

Analysis denominator · Participants

Group	Source count
All Patients	45

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	184.8	140.13	Not reported	Not reported	Not reported

Ext Week 43 n=22

Analysis denominator · Participants

Group	Source count
All Patients	22

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	136.1	91.13	Not reported	Not reported	Not reported

Ext Week 51 n=20

Analysis denominator · Participants

Group	Source count
All Patients	20

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	156.8	108.91	Not reported	Not reported	Not reported

Ext Week 59 n=24

Analysis denominator · Participants

Group	Source count
All Patients	24

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	157.7	111.63	Not reported	Not reported	Not reported

Ext Week 67 n=17

Analysis denominator · Participants

Group	Source count
All Patients	17

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	213.8	194.99	Not reported	Not reported	Not reported

Ext Week 75 n=18

Analysis denominator · Participants

Group	Source count
All Patients	18

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	157.6	166.28	Not reported	Not reported	Not reported

Ext Week 83 n=20

Analysis denominator · Participants

Group	Source count
All Patients	20

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	157.9	134.98	Not reported	Not reported	Not reported

Ext Week 91 n=18

Analysis denominator · Participants

Group	Source count
All Patients	18

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	180.0	302.36	Not reported	Not reported	Not reported

Ext Week 99 n=13

Analysis denominator · Participants

Group	Source count
All Patients	13

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	222.5	375.67	Not reported	Not reported	Not reported

Ext Week 107 n=12

Analysis denominator · Participants

Group	Source count
All Patients	12

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	118.5	122.01	Not reported	Not reported	Not reported

Ext Week 115 n=13

Analysis denominator · Participants

Group	Source count
All Patients	13

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	126.0	80.09	Not reported	Not reported	Not reported

Ext Week 123 n=13

Analysis denominator · Participants

Group	Source count
All Patients	13

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	147.5	157.77	Not reported	Not reported	Not reported

Ext Week 131 n=11

Analysis denominator · Participants

Group	Source count
All Patients	11

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	76.4	49.92	Not reported	Not reported	Not reported

Ext Week 139 n=9

Analysis denominator · Participants

Group	Source count
All Patients	9

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	92.9	73.18	Not reported	Not reported	Not reported

Ext Week 147 n=9

Analysis denominator · Participants

Group	Source count
All Patients	9

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	90.1	55.31	Not reported	Not reported	Not reported

Ext Week 155 n=4

Analysis denominator · Participants

Group	Source count
All Patients	4

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	76.3	39.05	Not reported	Not reported	Not reported

Ext Week 163 n=6

Analysis denominator · Participants

Group	Source count
All Patients	6

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	141.1	142.42	Not reported	Not reported	Not reported

Ext Week 171 n=6

Analysis denominator · Participants

Group	Source count
All Patients	6

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	89.5	61.87	Not reported	Not reported	Not reported

Ext Week 179 n=4

Analysis denominator · Participants

Group	Source count
All Patients	4

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	61.3	43.06	Not reported	Not reported	Not reported

Ext Week 187 n=4

Analysis denominator · Participants

Group	Source count
All Patients	4

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	89.9	52.44	Not reported	Not reported	Not reported

Ext Week 195 n=3

Analysis denominator · Participants

Group	Source count
All Patients	3

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	46.1	40.21	Not reported	Not reported	Not reported

Ext Week 203 n=4

Analysis denominator · Participants

Group	Source count
All Patients	4

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	194.0	259.15	Not reported	Not reported	Not reported

Ext Week 211 n=3

Analysis denominator · Participants

Group	Source count
All Patients	3

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	107.3	37.68	Not reported	Not reported	Not reported

Ext Week 219 n=2

Analysis denominator · Participants

Group	Source count
All Patients	2

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	70.6	46.74	Not reported	Not reported	Not reported

Ext Week 227 n=2

Analysis denominator · Participants

Group	Source count
All Patients	2

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	47.1	7.99	Not reported	Not reported	Not reported

Ext Week 235 n=3

Analysis denominator · Participants

Group	Source count
All Patients	3

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	62.0	23.83	Not reported	Not reported	Not reported

Ext Week 243 n=1

Analysis denominator · Participants

Group	Source count
All Patients	1

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	117.7	Not reported	Not reported	Not reported	Not reported

Ext Week 251 n=1

Analysis denominator · Participants

Group	Source count
All Patients	1

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	202.9	Not reported	Not reported	Not reported	Not reported

Ext Week 267 n=1

Analysis denominator · Participants

Group	Source count
All Patients	1

Values in nmol/24h · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	249.0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
488.66
value
501.6
denoms
counts
group Id
OG000
value
68
units
Participants
title
Baseline
categories
measurements
group Id
OG000
spread
100.69
value
217.0
denoms
counts
group Id
OG000
value
8
units
Participants
title
Core Week 2 n-8
categories
measurements
group Id
OG000
spread
203.47
value
242.1
denoms
counts
group Id
OG000
value
59
units
Participants
title
Core Week 4 n=59
categories
measurements
group Id
OG000
spread
195.21
value
230.0
denoms
counts
group Id
OG000
value
58
units
Participants
title
Core Week 8 n=58
categories
measurements
group Id
OG000
spread
240.98
value
231.0
denoms
counts
group Id
OG000
value
51
units
Participants
title
Core Week 13 n=51
categories
measurements
group Id
OG000
spread
429.64
value
310.3
denoms
counts
group Id
OG000
value
57
units
Participants
title
Core Week 17 n=57
categories
measurements
group Id
OG000
spread
202.80
value
214.0
denoms
counts
group Id
OG000
value
50
units
Participants
title
Core Week 22 n=50
categories
measurements
group Id
OG000
spread
173.58
value
211.6
denoms
counts
group Id
OG000
value
54
units
Participants
title
Core Week 26 n=54
categories
measurements
group Id
OG000
spread
104.16
value
154.3
denoms
counts
group Id
OG000
value
46
units
Participants
title
Core Week 31 n=46
categories
measurements
group Id
OG000
spread
140.13
value
184.8
denoms
counts
group Id
OG000
value
45
units
Participants
title
Core Week 35 n=45
categories
measurements
group Id
OG000
spread
91.13
value
136.1
denoms
counts
group Id
OG000
value
22
units
Participants
title
Ext Week 43 n=22
categories
measurements
group Id
OG000
spread
108.91
value
156.8
denoms
counts
group Id
OG000
value
20
units
Participants
title
Ext Week 51 n=20

denoms

counts
group Id
OG000
value
68
units
Participants

description

Mean value of mUFC at each scheduled visit was determined from two 24-hour urine collections collected on two consecutive days that occurred before the visit when UFC was measured.

dispersion Type

Standard Deviation

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

MEAN

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 8 weeks during extension

title

Mean Urinary Free Cortisol (mUFC) at Scheduled Visits

type

SECONDARY

unit Of Measure

nmol/24h

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

Preserved source evidence · Not medical advice