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NCT01915303 · OUTCOME

Plasma Adrenocorticotropic Hormone (ACTH)

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: pmol/L
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

A pre-dose blood draw for plasma ACTH sampling was taken at visits. Samples were analyzed by a central laboratory.

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

Baseline

Analysis denominator · Participants

Group	Source count
All Patients	68

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	16.3	16.3	Not reported	Not reported	Not reported

Core Week 2 n-62

Analysis denominator · Participants

Group	Source count
All Patients	62

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	12.4	9.91	Not reported	Not reported	Not reported

Core Week 4 n=63

Analysis denominator · Participants

Group	Source count
All Patients	63

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	14.2	12.50	Not reported	Not reported	Not reported

Core Week 8 n=61

Analysis denominator · Participants

Group	Source count
All Patients	61

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	13.3	11.90	Not reported	Not reported	Not reported

Core Week 13 n=53

Analysis denominator · Participants

Group	Source count
All Patients	53

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	11.9	10.98	Not reported	Not reported	Not reported

Core Week 17 n=58

Analysis denominator · Participants

Group	Source count
All Patients	58

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	12.3	9.03	Not reported	Not reported	Not reported

Core Week 22 n=49

Analysis denominator · Participants

Group	Source count
All Patients	49

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	13.7	13.82	Not reported	Not reported	Not reported

Core Week 26 n=55

Analysis denominator · Participants

Group	Source count
All Patients	55

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	12.4	12.09	Not reported	Not reported	Not reported

Core Week 31 n=49

Analysis denominator · Participants

Group	Source count
All Patients	49

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	12.1	11.02	Not reported	Not reported	Not reported

Core Week 35 n=40

Analysis denominator · Participants

Group	Source count
All Patients	40

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	11.0	8.71	Not reported	Not reported	Not reported

Ext Week 43 n=23

Analysis denominator · Participants

Group	Source count
All Patients	23

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	11.5	8.12	Not reported	Not reported	Not reported

Ext Week 51 n=21

Analysis denominator · Participants

Group	Source count
All Patients	21

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	10.4	6.80	Not reported	Not reported	Not reported

Ext Week 59 n=23

Analysis denominator · Participants

Group	Source count
All Patients	23

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	10.7	6.89	Not reported	Not reported	Not reported

Ext Week 67 n=22

Analysis denominator · Participants

Group	Source count
All Patients	22

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	11.0	7.23	Not reported	Not reported	Not reported

Ext Week 75 n=22

Analysis denominator · Participants

Group	Source count
All Patients	22

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	9.1	4.16	Not reported	Not reported	Not reported

Ext Week 83 n=19

Analysis denominator · Participants

Group	Source count
All Patients	19

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	9.8	8.20	Not reported	Not reported	Not reported

Ext Week 91 n=19

Analysis denominator · Participants

Group	Source count
All Patients	19

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	10.6	8.34	Not reported	Not reported	Not reported

Ext Week 99 n=16

Analysis denominator · Participants

Group	Source count
All Patients	16

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	11.3	8.50	Not reported	Not reported	Not reported

Ext Week 107 n=13

Analysis denominator · Participants

Group	Source count
All Patients	13

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	9.3	6.61	Not reported	Not reported	Not reported

Ext Week 115 n=15

Analysis denominator · Participants

Group	Source count
All Patients	15

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	9.5	7.22	Not reported	Not reported	Not reported

Ext Week 123 n=14

Analysis denominator · Participants

Group	Source count
All Patients	14

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	10.6	8.24	Not reported	Not reported	Not reported

Ext Week 131 n=12

Analysis denominator · Participants

Group	Source count
All Patients	12

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	8.2	6.01	Not reported	Not reported	Not reported

Ext Week 139 n=10

Analysis denominator · Participants

Group	Source count
All Patients	10

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	10.0	7.01	Not reported	Not reported	Not reported

Ext Week 147 n=9

Analysis denominator · Participants

Group	Source count
All Patients	9

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	10.4	7.02	Not reported	Not reported	Not reported

Ext Week 155 n=9

Analysis denominator · Participants

Group	Source count
All Patients	9

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	10.4	7.02	Not reported	Not reported	Not reported

Ext Week 163 n=5

Analysis denominator · Participants

Group	Source count
All Patients	5

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	10.0	4.85	Not reported	Not reported	Not reported

Ext Week 171 n=5

Analysis denominator · Participants

Group	Source count
All Patients	5

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	7.4	3.36	Not reported	Not reported	Not reported

Ext Week 179 n=5

Analysis denominator · Participants

Group	Source count
All Patients	5

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	7.0	3.32	Not reported	Not reported	Not reported

Ext Week 187 n=5

Analysis denominator · Participants

Group	Source count
All Patients	5

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	8.6	5.32	Not reported	Not reported	Not reported

Ext Week 195 n=4

Analysis denominator · Participants

Group	Source count
All Patients	4

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	9.0	4.76	Not reported	Not reported	Not reported

Ext Week 203 n=4

Analysis denominator · Participants

Group	Source count
All Patients	4

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	8.0	2.94	Not reported	Not reported	Not reported

Ext Week 211 n=3

Analysis denominator · Participants

Group	Source count
All Patients	3

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	11.0	4.58	Not reported	Not reported	Not reported

Ext Week 219 n=2

Analysis denominator · Participants

Group	Source count
All Patients	2

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	6.0	0.00	Not reported	Not reported	Not reported

Ext Week 227 n=2

Analysis denominator · Participants

Group	Source count
All Patients	2

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	7.0	1.41	Not reported	Not reported	Not reported

Ext Week 235 n=3

Analysis denominator · Participants

Group	Source count
All Patients	3

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	10.3	3.21	Not reported	Not reported	Not reported

Ext Week 243 n=1

Analysis denominator · Participants

Group	Source count
All Patients	1

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	6.0	Not reported	Not reported	Not reported	Not reported

Ext Week 251 n=1

Analysis denominator · Participants

Group	Source count
All Patients	1

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	7.0	Not reported	Not reported	Not reported	Not reported

Ext Week 267 n=1

Analysis denominator · Participants

Group	Source count
All Patients	1

Values in pmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	4.0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
16.3
value
16.3
denoms
counts
group Id
OG000
value
68
units
Participants
title
Baseline
categories
measurements
group Id
OG000
spread
9.91
value
12.4
denoms
counts
group Id
OG000
value
62
units
Participants
title
Core Week 2 n-62
categories
measurements
group Id
OG000
spread
12.50
value
14.2
denoms
counts
group Id
OG000
value
63
units
Participants
title
Core Week 4 n=63
categories
measurements
group Id
OG000
spread
11.90
value
13.3
denoms
counts
group Id
OG000
value
61
units
Participants
title
Core Week 8 n=61
categories
measurements
group Id
OG000
spread
10.98
value
11.9
denoms
counts
group Id
OG000
value
53
units
Participants
title
Core Week 13 n=53
categories
measurements
group Id
OG000
spread
9.03
value
12.3
denoms
counts
group Id
OG000
value
58
units
Participants
title
Core Week 17 n=58
categories
measurements
group Id
OG000
spread
13.82
value
13.7
denoms
counts
group Id
OG000
value
49
units
Participants
title
Core Week 22 n=49
categories
measurements
group Id
OG000
spread
12.09
value
12.4
denoms
counts
group Id
OG000
value
55
units
Participants
title
Core Week 26 n=55
categories
measurements
group Id
OG000
spread
11.02
value
12.1
denoms
counts
group Id
OG000
value
49
units
Participants
title
Core Week 31 n=49
categories
measurements
group Id
OG000
spread
8.71
value
11.0
denoms
counts
group Id
OG000
value
40
units
Participants
title
Core Week 35 n=40
categories
measurements
group Id
OG000
spread
8.12
value
11.5
denoms
counts
group Id
OG000
value
23
units
Participants
title
Ext Week 43 n=23
categories
measurements
group Id
OG000
spread
6.80
value
10.4
denoms
counts
group Id
OG000
value
21
units
Participants
title
Ext Week 51 n=21

denoms

counts
group Id
OG000
value
68
units
Participants

description

A pre-dose blood draw for plasma ACTH sampling was taken at visits. Samples were analyzed by a central laboratory.

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

reporting Status

POSTED

time Frame

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

title

Plasma Adrenocorticotropic Hormone (ACTH)

type

SECONDARY

unit Of Measure

pmol/L

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

Preserved source evidence · Not medical advice