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NCT01137682 · OUTCOME

Change From Baseline in AcroQoL Total Scores 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: scores on a scale
Interval / dispersion: Standard Deviation
Time frame: CORE Baseline and extension baseline up to approximately 268 weeks

What was measured

Acromegaly Quality of Life questionnaire (AcroQoL) is a validated disease specific questionnaire. It contains 22 items divided into two scales: physical aspects (8 items) and psychological aspects (14 items) which is divided in two sub-scales: physical appearance and personal relationships of the patient (seven items each). The total score and sub-scores were calculated using the following formula: ((X -Y) / 4Y) x 100, X=sum of the scores for individual items (between 1 and 5 for each item), Y=number of individual items included in above sum (i.e. 22 for the total score, 8 for the physical sub-score, 14 for the psychological sub-score, 7 for the sub-score 'appearance' and 'personal relations'). The scoring of the questionnaire was performed as specified by the instrument developers. Total scores range from 0 to 100. Higher scores represent better quality of life. If more than 25% of items are not completed, results were considered invalid.

Analysis population: completed and valid questionnaires at visits

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	50
Pasireotide LAR 60 mg Extension	46
Cross Over to Pasireotide Extension	61

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	4.2	16.34	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	2.9	19.09	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	0.8	10.22	Not reported	Not reported	Not reported

Week 28 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	46
Pasireotide LAR 60 mg Extension	40
Cross Over to Pasireotide Extension	54

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	5.6	13.21	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	4.8	16.83	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	3.3	10.70	Not reported	Not reported	Not reported

Week 40 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	44
Pasireotide LAR 60 mg Extension	41
Cross Over to Pasireotide Extension	51

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	3.2	15.78	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	2.5	18.21	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	3.2	10.31	Not reported	Not reported	Not reported

Week 52 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	41
Pasireotide LAR 60 mg Extension	36
Cross Over to Pasireotide Extension	46

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	6.1	14.28	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	5.7	18.69	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	4.2	11.01	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	43

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	5.8	13.65	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	4.2	18.89	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	5.4	12.12	Not reported	Not reported	Not reported

Week 76 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	31
Pasireotide LAR 60 mg Extension	36
Cross Over to Pasireotide Extension	42

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	7.7	14.93	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	2.5	19.30	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	7.7	15.17	Not reported	Not reported	Not reported

Week 88 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	35
Pasireotide LAR 60 mg Extension	32
Cross Over to Pasireotide Extension	42

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	4.6	15.11	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	5.6	18.08	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	6.4	10.29	Not reported	Not reported	Not reported

Week 100 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	34
Pasireotide LAR 60 mg Extension	32
Cross Over to Pasireotide Extension	40

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	4.3	14.80	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	3.9	16.91	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	5.9	11.13	Not reported	Not reported	Not reported

Week 112 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	32
Pasireotide LAR 60 mg Extension	31
Cross Over to Pasireotide Extension	39

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	4.6	15.83	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	6.5	18.36	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	4.1	10.35	Not reported	Not reported	Not reported

Week 124 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	28
Pasireotide LAR 60 mg Extension	30
Cross Over to Pasireotide Extension	37

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	5.8	16.46	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	2.0	17.95	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	2.0	10.97	Not reported	Not reported	Not reported

Week 136 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	28
Pasireotide LAR 60 mg Extension	28
Cross Over to Pasireotide Extension	39

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	7.5	18.72	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	5.4	16.73	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	6.5	11.82	Not reported	Not reported	Not reported

Week 148 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	29
Pasireotide LAR 60 mg Extension	26
Cross Over to Pasireotide Extension	37

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	7.6	18.56	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	6.8	16.65	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	5.5	12.95	Not reported	Not reported	Not reported

Week 160 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	30
Pasireotide LAR 60 mg Extension	26
Cross Over to Pasireotide Extension	31

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	7.0	19.10	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	5.1	15.70	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	1.5	13.36	Not reported	Not reported	Not reported

Week 172 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	28
Pasireotide LAR 60 mg Extension	26
Cross Over to Pasireotide Extension	31

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	4.8	17.97	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	5.7	17.52	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	2.1	12.13	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	29

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	5.8	15.31	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	5.8	16.83	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	1.6	12.45	Not reported	Not reported	Not reported

Week 196 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	21
Pasireotide LAR 60 mg Extension	22
Cross Over to Pasireotide Extension	27

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	6.1	16.94	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	6.0	18.58	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	3.8	13.11	Not reported	Not reported	Not reported

Week 208 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	22
Pasireotide LAR 60 mg Extension	23
Cross Over to Pasireotide Extension	21

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	1.2	13.27	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	6.2	17.31	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	4.5	12.62	Not reported	Not reported	Not reported

Week 220 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	19
Pasireotide LAR 60 mg Extension	16
Cross Over to Pasireotide Extension	21

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	4.8	21.99	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	5.8	17.12	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	7.3	16.28	Not reported	Not reported	Not reported

Week 232 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	19
Pasireotide LAR 60 mg Extension	12
Cross Over to Pasireotide Extension	16

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	2.1	17.51	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	-0.2	16.73	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	7.0	15.15	Not reported	Not reported	Not reported

Week 244 extension

Analysis denominator · Participants

Group	Source count
Pasireotide LAR 40 mg Extension	13
Pasireotide LAR 60 mg Extension	7
Cross Over to Pasireotide Extension	10

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	4.5	20.06	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	6.3	11.05	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	3.0	18.65	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	7

Values in scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	6.1	25.91	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	-3.0	7.07	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	0.3	14.08	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 scores on a scale · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Pasireotide LAR 40 mg Extension	0.6	16.74	Not reported	Not reported	Not reported
Pasireotide LAR 60 mg Extension	-4.9	4.30	Not reported	Not reported	Not reported
Cross Over to Pasireotide Extension	-10.6	7.57	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
16.34
value
4.2
group Id
OG001
spread
19.09
value
2.9
group Id
OG002
spread
10.22
value
0.8
denoms
counts
group Id
OG000
value
50
group Id
OG001
value
46
group Id
OG002
value
61
units
Participants
title
Week 16 extension
categories
measurements
group Id
OG000
spread
13.21
value
5.6
group Id
OG001
spread
16.83
value
4.8
group Id
OG002
spread
10.70
value
3.3
denoms
counts
group Id
OG000
value
46
group Id
OG001
value
40
group Id
OG002
value
54
units
Participants
title
Week 28 extension
categories
measurements
group Id
OG000
spread
15.78
value
3.2
group Id
OG001
spread
18.21
value
2.5
group Id
OG002
spread
10.31
value
3.2
denoms
counts
group Id
OG000
value
44
group Id
OG001
value
41
group Id
OG002
value
51
units
Participants
title
Week 40 extension
categories
measurements
group Id
OG000
spread
14.28
value
6.1
group Id
OG001
spread
18.69
value
5.7
group Id
OG002
spread
11.01
value
4.2
denoms
counts
group Id
OG000
value
41
group Id
OG001
value
36
group Id
OG002
value
46
units
Participants
title
Week 52 extension
categories
measurements
group Id
OG000
spread
13.65
value
5.8
group Id
OG001
spread
18.89
value
4.2
group Id
OG002
spread
12.12
value
5.4
denoms
counts
group Id
OG000
value
37
group Id
OG001
value
35
group Id
OG002
value
43
units
Participants
title
Week 64 extension
categories
measurements
group Id
OG000
spread
14.93
value
7.7
group Id
OG001
spread
19.30
value
2.5
group Id
OG002
spread
15.17
value
7.7
denoms
counts
group Id
OG000
value
31
group Id
OG001
value
36
group Id
OG002
value
42
units
Participants
title
Week 76 extension
categories
measurements
group Id
OG000
spread
15.11
value
4.6
group Id
OG001
spread
18.08
value
5.6
group Id
OG002
spread
10.29
value
6.4
denoms
counts
group Id
OG000
value
35
group Id
OG001
value
32
group Id
OG002
value
42
units
Participants
title
Week 88 extension
categories
measurements
group Id
OG000
spread
14.80
value
4.3
group Id
OG001
spread
16.91
value
3.9
group Id
OG002
spread
11.13
value
5.9
denoms
counts
group Id
OG000
value
34
group Id
OG001
value
32
group Id
OG002
value
40
units
Participants
title
Week 100 extension
categories
measurements
group Id
OG000
spread
15.83
value
4.6
group Id
OG001
spread
18.36
value
6.5
group Id
OG002
spread
10.35
value
4.1
denoms
counts
group Id
OG000
value
32
group Id
OG001
value
31
group Id
OG002
value
39
units
Participants
title
Week 112 extension
categories
measurements
group Id
OG000
spread
16.46
value
5.8
group Id
OG001
spread
17.95
value
2.0
group Id
OG002
spread
10.97
value
2.0
denoms
counts
group Id
OG000
value
28
group Id
OG001
value
30
group Id
OG002
value
37
units
Participants
title
Week 124 extension
categories
measurements
group Id
OG000
spread
18.72
value
7.5
group Id
OG001
spread
16.73
value
5.4
group Id
OG002
spread
11.82
value
6.5
denoms
counts
group Id
OG000
value
28
group Id
OG001
value
28
group Id
OG002
value
39
units
Participants
title
Week 136 extension
categories
measurements
group Id
OG000
spread
18.56
value
7.6
group Id
OG001
spread
16.65
value
6.8
group Id
OG002
spread
12.95
value
5.5
denoms
counts
group Id
OG000
value
29
group Id
OG001
value
26
group Id
OG002
value
37
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

Acromegaly Quality of Life questionnaire (AcroQoL) is a validated disease specific questionnaire. It contains 22 items divided into two scales: physical aspects (8 items) and psychological aspects (14 items) which is divided in two sub-scales: physical appearance and personal relationships of the patient (seven items each). The total score and sub-scores were calculated using the following formula: ((X -Y) / 4Y) x 100, X=sum of the scores for individual items (between 1 and 5 for each item), Y=number of individual items included in above sum (i.e. 22 for the total score, 8 for the physical sub-score, 14 for the psychological sub-score, 7 for the sub-score 'appearance' and 'personal relations'). The scoring of the questionnaire was performed as specified by the instrument developers. Total scores range from 0 to 100. Higher scores represent better quality of life. If more than 25% of items are not completed, results were considered invalid.

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

completed and valid questionnaires at visits

reporting Status

POSTED

time Frame

CORE Baseline and extension baseline up to approximately 268 weeks

title

Change From Baseline in AcroQoL Total Scores 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

scores on a scale

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

Preserved source evidence · Not medical advice