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NCT01137682 · OUTCOME

Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set)

Efficacy and Safety of Pasireotide Long Acting Release (LAR) Versus Octreotide LAR or Lanreotide Autogel (ATG) in Patients With Inadequately Controlled Acromegaly · Source last updated 2018-04-05

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: mcg/L
Interval / dispersion: Standard Deviation
Time frame: CORE and extension baseline up to approximately 268 weeks

What was measured

Change from CORE baseline at each scheduled assessment was performed for patients randomized to pasireotide arms. Change from extension baseline at each scheduled assessment was performed for patients randomized to active control arm. Standardized IGF-1 = IGF-1 value / ULN, where ULN is the upper limit of the normal range

Analysis population: Available data for analysis differed from visit to visit

Groups in this outcome

Pasireotide LAR 40 mg Extension

If controlled on 40 mg in CORE, remain on blinded 40 mg in extension. If patient became uncontrolled, switch to open label 60 mg

Pasireotide LAR 60 mg Extension

If controlled on 60 mg in CORE, remain on blinded 60 mg in extension. If patient became uncontrolled, switch to open label 60 mg

Cross Over to Pasireotide Extension

Open - label 60 mg pasireotide. Control group from CORE discontinued study if controlled in CORE. If uncontrolled in CORE, switched to open label 60 mg pasireotide. Extension blinded 40 and 60 mg switched to open label if became uncontrolled.

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
Pasireotide LAR 40 mg Extension	57
Pasireotide LAR 60 mg Extension	54
Cross Over to Pasireotide Extension	62

Reported measurements

Week 16 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	49
Pasireotide LAR 60 mg Extension	47
Cross Over to Pasireotide Extension	61

Values in mcg/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	-0.8	0.99	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	-1.4	0.97	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	-0.9	0.81	Not reported	Not reported	Not reported

Week 28 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	45
Pasireotide LAR 60 mg Extension	39
Cross Over to Pasireotide Extension	58

Values in mcg/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	-0.9	1.00	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	-1.3	1.13	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	-0.9	0.88	Not reported	Not reported	Not reported

Week 40 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	42
Pasireotide LAR 60 mg Extension	37
Cross Over to Pasireotide Extension	51

Values in mcg/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	-1.1	0.95	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	-1.4	0.94	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	-1.1	0.91	Not reported	Not reported	Not reported

Week 52 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	39
Pasireotide LAR 60 mg Extension	37
Cross Over to Pasireotide Extension	46

Values in mcg/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	-1.1	0.90	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	-1.3	0.95	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	-1.1	0.95	Not reported	Not reported	Not reported

Week 64 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	37
Pasireotide LAR 60 mg Extension	35
Cross Over to Pasireotide Extension	42

Values in mcg/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	-1.3	0.99	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	-1.4	0.98	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	-1.3	0.81	Not reported	Not reported	Not reported

Week 76 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	33
Pasireotide LAR 60 mg Extension	36
Cross Over to Pasireotide Extension	43

Values in mcg/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	-1.3	0.87	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	-1.5	0.94	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	-1.3	0.84	Not reported	Not reported	Not reported

Week 88 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	33
Pasireotide LAR 60 mg Extension	32
Cross Over to Pasireotide Extension	41

Values in mcg/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	-1.3	0.80	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	-1.6	1.01	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	-1.3	0.90	Not reported	Not reported	Not reported

Week 100 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	32
Pasireotide LAR 60 mg Extension	32
Cross Over to Pasireotide Extension	40

Values in mcg/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	-1.4	0.93	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	-1.5	0.95	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	-1.3	0.92	Not reported	Not reported	Not reported

Week 112 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	31
Pasireotide LAR 60 mg Extension	32
Cross Over to Pasireotide Extension	38

Values in mcg/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	-1.5	0.87	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	-1.5	1.00	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	-1.4	0.89	Not reported	Not reported	Not reported

Week 124 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	31
Pasireotide LAR 60 mg Extension	28
Cross Over to Pasireotide Extension	38

Values in mcg/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	-1.4	0.86	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	-1.5	0.95	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	-1.3	0.97	Not reported	Not reported	Not reported

Week 136 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	29
Pasireotide LAR 60 mg Extension	27
Cross Over to Pasireotide Extension	38

Values in mcg/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	-1.4	0.91	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	-1.7	0.92	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	-1.4	0.86	Not reported	Not reported	Not reported

Week 148 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	28
Pasireotide LAR 60 mg Extension	26
Cross Over to Pasireotide Extension	36

Values in mcg/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	-1.4	0.86	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	-1.5	0.99	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	-1.3	0.84	Not reported	Not reported	Not reported

Week 160 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	29
Pasireotide LAR 60 mg Extension	28
Cross Over to Pasireotide Extension	34

Values in mcg/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	-1.4	0.90	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	-1.6	0.87	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	-1.4	0.94	Not reported	Not reported	Not reported

Week 172 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	26
Pasireotide LAR 60 mg Extension	27
Cross Over to Pasireotide Extension	31

Values in mcg/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	-1.5	0.81	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	-1.6	0.97	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	-1.3	0.98	Not reported	Not reported	Not reported

Week 184 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	23
Pasireotide LAR 60 mg Extension	25
Cross Over to Pasireotide Extension	31

Values in mcg/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	-1.3	0.70	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	-1.5	1.03	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	-1.4	0.93	Not reported	Not reported	Not reported

Week 196 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	23
Pasireotide LAR 60 mg Extension	22
Cross Over to Pasireotide Extension	29

Values in mcg/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	-1.4	0.81	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	-1.5	1.11	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	-1.3	1.11	Not reported	Not reported	Not reported

Week 208 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	23
Pasireotide LAR 60 mg Extension	22
Cross Over to Pasireotide Extension	22

Values in mcg/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	-1.4	0.79	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	-1.6	1.00	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	-1.2	0.98	Not reported	Not reported	Not reported

Week 220 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	20
Pasireotide LAR 60 mg Extension	14
Cross Over to Pasireotide Extension	20

Values in mcg/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	-1.4	0.94	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	-1.6	1.06	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	-1.4	0.91	Not reported	Not reported	Not reported

Week 232 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	15
Pasireotide LAR 60 mg Extension	15
Cross Over to Pasireotide Extension	15

Values in mcg/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	-1.4	0.92	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	-1.5	1.13	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	-1.7	0.82	Not reported	Not reported	Not reported

Week 244 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	12
Pasireotide LAR 60 mg Extension	8
Cross Over to Pasireotide Extension	11

Values in mcg/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	-1.3	0.75	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	-1.9	1.12	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	-1.5	0.79	Not reported	Not reported	Not reported

Week 256 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	10
Pasireotide LAR 60 mg Extension	6
Cross Over to Pasireotide Extension	6

Values in mcg/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	-1.3	0.58	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	-1.4	1.39	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	-1.8	0.90	Not reported	Not reported	Not reported

Week 268 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	4
Pasireotide LAR 60 mg Extension	3
Cross Over to Pasireotide Extension	3

Values in mcg/L · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	-1.4	0.43	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	-1.7	0.39	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	-1.7	0.81	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.99
value
-0.8
group Id
OG001
spread
0.97
value
-1.4
group Id
OG002
spread
0.81
value
-0.9
denoms
counts
group Id
OG000
value
49
group Id
OG001
value
47
group Id
OG002
value
61
units
Participants
title
Week 16 extension
categories
measurements
group Id
OG000
spread
1.00
value
-0.9
group Id
OG001
spread
1.13
value
-1.3
group Id
OG002
spread
0.88
value
-0.9
denoms
counts
group Id
OG000
value
45
group Id
OG001
value
39
group Id
OG002
value
58
units
Participants
title
Week 28 extension
categories
measurements
group Id
OG000
spread
0.95
value
-1.1
group Id
OG001
spread
0.94
value
-1.4
group Id
OG002
spread
0.91
value
-1.1
denoms
counts
group Id
OG000
value
42
group Id
OG001
value
37
group Id
OG002
value
51
units
Participants
title
Week 40 extension
categories
measurements
group Id
OG000
spread
0.90
value
-1.1
group Id
OG001
spread
0.95
value
-1.3
group Id
OG002
spread
0.95
value
-1.1
denoms
counts
group Id
OG000
value
39
group Id
OG001
value
37
group Id
OG002
value
46
units
Participants
title
Week 52 extension
categories
measurements
group Id
OG000
spread
0.99
value
-1.3
group Id
OG001
spread
0.98
value
-1.4
group Id
OG002
spread
0.81
value
-1.3
denoms
counts
group Id
OG000
value
37
group Id
OG001
value
35
group Id
OG002
value
42
units
Participants
title
Week 64 extension
categories
measurements
group Id
OG000
spread
0.87
value
-1.3
group Id
OG001
spread
0.94
value
-1.5
group Id
OG002
spread
0.84
value
-1.3
denoms
counts
group Id
OG000
value
33
group Id
OG001
value
36
group Id
OG002
value
43
units
Participants
title
Week 76 extension
categories
measurements
group Id
OG000
spread
0.80
value
-1.3
group Id
OG001
spread
1.01
value
-1.6
group Id
OG002
spread
0.90
value
-1.3
denoms
counts
group Id
OG000
value
33
group Id
OG001
value
32
group Id
OG002
value
41
units
Participants
title
Week 88 extension
categories
measurements
group Id
OG000
spread
0.93
value
-1.4
group Id
OG001
spread
0.95
value
-1.5
group Id
OG002
spread
0.92
value
-1.3
denoms
counts
group Id
OG000
value
32
group Id
OG001
value
32
group Id
OG002
value
40
units
Participants
title
Week 100 extension
categories
measurements
group Id
OG000
spread
0.87
value
-1.5
group Id
OG001
spread
1.00
value
-1.5
group Id
OG002
spread
0.89
value
-1.4
denoms
counts
group Id
OG000
value
31
group Id
OG001
value
32
group Id
OG002
value
38
units
Participants
title
Week 112 extension
categories
measurements
group Id
OG000
spread
0.86
value
-1.4
group Id
OG001
spread
0.95
value
-1.5
group Id
OG002
spread
0.97
value
-1.3
denoms
counts
group Id
OG000
value
31
group Id
OG001
value
28
group Id
OG002
value
38
units
Participants
title
Week 124 extension
categories
measurements
group Id
OG000
spread
0.91
value
-1.4
group Id
OG001
spread
0.92
value
-1.7
group Id
OG002
spread
0.86
value
-1.4
denoms
counts
group Id
OG000
value
29
group Id
OG001
value
27
group Id
OG002
value
38
units
Participants
title
Week 136 extension
categories
measurements
group Id
OG000
spread
0.86
value
-1.4
group Id
OG001
spread
0.99
value
-1.5
group Id
OG002
spread
0.84
value
-1.3
denoms
counts
group Id
OG000
value
28
group Id
OG001
value
26
group Id
OG002
value
36
units
Participants
title
Week 148 extension

denoms

counts
group Id
OG000
value
57
group Id
OG001
value
54
group Id
OG002
value
62
units
Participants

description

Change from CORE baseline at each scheduled assessment was performed for patients randomized to pasireotide arms. Change from extension baseline at each scheduled assessment was performed for patients randomized to active control arm. Standardized IGF-1 = IGF-1 value / ULN, where ULN is the upper limit of the normal range

dispersion Type

Standard Deviation

groups

description
If controlled on 40 mg in CORE, remain on blinded 40 mg in extension. If patient became uncontrolled, switch to open label 60 mg
id
OG000
title
Pasireotide LAR 40 mg Extension
description
If controlled on 60 mg in CORE, remain on blinded 60 mg in extension. If patient became uncontrolled, switch to open label 60 mg
id
OG001
title
Pasireotide LAR 60 mg Extension
description
Open - label 60 mg pasireotide. Control group from CORE discontinued study if controlled in CORE. If uncontrolled in CORE, switched to open label 60 mg pasireotide. Extension blinded 40 and 60 mg switched to open label if became uncontrolled.
id
OG002
title
Cross Over to Pasireotide Extension

param Type

MEAN

population Description

Available data for analysis differed from visit to visit

reporting Status

POSTED

time Frame

CORE and extension baseline up to approximately 268 weeks

title

Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set)

type

SECONDARY

unit Of Measure

mcg/L

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

Preserved source evidence · Not medical advice