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NCT01915303 · OUTCOME

Serum Cortisol Levels

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/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 an 8 am fasting serum cortisol measurement were 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 nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	738.6	332.53	Not reported	Not reported	Not reported

Core Week 2 n-62

Analysis denominator · Participants

Group	Source count
All Patients	62

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	626.1	281.57	Not reported	Not reported	Not reported

Core Week 4 n=64

Analysis denominator · Participants

Group	Source count
All Patients	64

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	663.6	292.38	Not reported	Not reported	Not reported

Core Week 8 n=61

Analysis denominator · Participants

Group	Source count
All Patients	61

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	649.0	297.11	Not reported	Not reported	Not reported

Core Week 13 n=53

Analysis denominator · Participants

Group	Source count
All Patients	53

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	628.8	269.43	Not reported	Not reported	Not reported

Core Week 17 n=58

Analysis denominator · Participants

Group	Source count
All Patients	58

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	683.0	282.28	Not reported	Not reported	Not reported

Core Week 22 n=49

Analysis denominator · Participants

Group	Source count
All Patients	49

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	625.4	216.29	Not reported	Not reported	Not reported

Core Week 26 n=55

Analysis denominator · Participants

Group	Source count
All Patients	55

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	632.7	278.75	Not reported	Not reported	Not reported

Core Week 31 n=49

Analysis denominator · Participants

Group	Source count
All Patients	49

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	597.5	247.60	Not reported	Not reported	Not reported

Core Week 35 n=40

Analysis denominator · Participants

Group	Source count
All Patients	40

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	538.2	205.40	Not reported	Not reported	Not reported

Ext Week 43 n=23

Analysis denominator · Participants

Group	Source count
All Patients	23

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	525.5	178.63	Not reported	Not reported	Not reported

Ext Week 51 n=21

Analysis denominator · Participants

Group	Source count
All Patients	21

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	512.2	243.59	Not reported	Not reported	Not reported

Ext Week 59 n=21

Analysis denominator · Participants

Group	Source count
All Patients	21

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	547.5	193.67	Not reported	Not reported	Not reported

Ext Week 67 n=22

Analysis denominator · Participants

Group	Source count
All Patients	22

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	495.4	213.03	Not reported	Not reported	Not reported

Ext Week 75 n=21

Analysis denominator · Participants

Group	Source count
All Patients	21

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	458.5	170.88	Not reported	Not reported	Not reported

Ext Week 83 n=19

Analysis denominator · Participants

Group	Source count
All Patients	19

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	419.5	141.26	Not reported	Not reported	Not reported

Ext Week 91 n=19

Analysis denominator · Participants

Group	Source count
All Patients	19

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	501.2	235.89	Not reported	Not reported	Not reported

Ext Week 99 n=16

Analysis denominator · Participants

Group	Source count
All Patients	16

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	470.9	248.0	Not reported	Not reported	Not reported

Ext Week 107 n=13

Analysis denominator · Participants

Group	Source count
All Patients	13

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	463.4	189.27	Not reported	Not reported	Not reported

Ext Week 115 n=15

Analysis denominator · Participants

Group	Source count
All Patients	15

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	501.7	212.27	Not reported	Not reported	Not reported

Ext Week 123 n=14

Analysis denominator · Participants

Group	Source count
All Patients	14

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	441.6	150.98	Not reported	Not reported	Not reported

Ext Week 131 n=12

Analysis denominator · Participants

Group	Source count
All Patients	12

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	413.8	325.5	Not reported	Not reported	Not reported

Ext Week 139 n=10

Analysis denominator · Participants

Group	Source count
All Patients	10

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	404.0	90.87	Not reported	Not reported	Not reported

Ext Week 147 n=10

Analysis denominator · Participants

Group	Source count
All Patients	10

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	585.4	216.92	Not reported	Not reported	Not reported

Ext Week 155 n=8

Analysis denominator · Participants

Group	Source count
All Patients	8

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	472.5	122.96	Not reported	Not reported	Not reported

Ext Week 163 n=6

Analysis denominator · Participants

Group	Source count
All Patients	6

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	617.0	212.11	Not reported	Not reported	Not reported

Ext Week 171 n=5

Analysis denominator · Participants

Group	Source count
All Patients	5

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	648.6	243.79	Not reported	Not reported	Not reported

Ext Week 179 n=5

Analysis denominator · Participants

Group	Source count
All Patients	5

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	599.0	388.78	Not reported	Not reported	Not reported

Ext Week 187 n=5

Analysis denominator · Participants

Group	Source count
All Patients	5

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	609.8	292.85	Not reported	Not reported	Not reported

Ext Week 195 n=4

Analysis denominator · Participants

Group	Source count
All Patients	4

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	418.8	138.69	Not reported	Not reported	Not reported

Ext Week 203 n=4

Analysis denominator · Participants

Group	Source count
All Patients	4

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	514.0	212.27	Not reported	Not reported	Not reported

Ext Week 211 n=3

Analysis denominator · Participants

Group	Source count
All Patients	3

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	551.3	339.87	Not reported	Not reported	Not reported

Ext Week 219 n=2

Analysis denominator · Participants

Group	Source count
All Patients	2

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	482.0	25.46	Not reported	Not reported	Not reported

Ext Week 227 n=2

Analysis denominator · Participants

Group	Source count
All Patients	2

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	324.5	177.48	Not reported	Not reported	Not reported

Ext Week 235 n=3

Analysis denominator · Participants

Group	Source count
All Patients	3

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	384.7	165.17	Not reported	Not reported	Not reported

Ext Week 243 n=1

Analysis denominator · Participants

Group	Source count
All Patients	1

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	679.0	Not reported	Not reported	Not reported	Not reported

Ext Week 251 n=1

Analysis denominator · Participants

Group	Source count
All Patients	1

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	574.0	Not reported	Not reported	Not reported	Not reported

Ext Week 267 n=1

Analysis denominator · Participants

Group	Source count
All Patients	1

Values in nmol/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
All Patients	638.0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
332.53
value
738.6
denoms
counts
group Id
OG000
value
68
units
Participants
title
Baseline
categories
measurements
group Id
OG000
spread
281.57
value
626.1
denoms
counts
group Id
OG000
value
62
units
Participants
title
Core Week 2 n-62
categories
measurements
group Id
OG000
spread
292.38
value
663.6
denoms
counts
group Id
OG000
value
64
units
Participants
title
Core Week 4 n=64
categories
measurements
group Id
OG000
spread
297.11
value
649.0
denoms
counts
group Id
OG000
value
61
units
Participants
title
Core Week 8 n=61
categories
measurements
group Id
OG000
spread
269.43
value
628.8
denoms
counts
group Id
OG000
value
53
units
Participants
title
Core Week 13 n=53
categories
measurements
group Id
OG000
spread
282.28
value
683.0
denoms
counts
group Id
OG000
value
58
units
Participants
title
Core Week 17 n=58
categories
measurements
group Id
OG000
spread
216.29
value
625.4
denoms
counts
group Id
OG000
value
49
units
Participants
title
Core Week 22 n=49
categories
measurements
group Id
OG000
spread
278.75
value
632.7
denoms
counts
group Id
OG000
value
55
units
Participants
title
Core Week 26 n=55
categories
measurements
group Id
OG000
spread
247.60
value
597.5
denoms
counts
group Id
OG000
value
49
units
Participants
title
Core Week 31 n=49
categories
measurements
group Id
OG000
spread
205.40
value
538.2
denoms
counts
group Id
OG000
value
40
units
Participants
title
Core Week 35 n=40
categories
measurements
group Id
OG000
spread
178.63
value
525.5
denoms
counts
group Id
OG000
value
23
units
Participants
title
Ext Week 43 n=23
categories
measurements
group Id
OG000
spread
243.59
value
512.2
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 an 8 am fasting serum cortisol measurement were 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

Serum Cortisol Levels

type

SECONDARY

unit Of Measure

nmol/L

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

Preserved source evidence · Not medical advice