Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline
Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues · Source last updated 2019-12-10
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
Weeks 12, 24 & 36
What was measured
Symptoms of acromegaly were collected at various visits. The measurement was to be provided on a scale of 1-15 including half sizes. Investigators asked the participants to score the following symptoms of acromegaly: headache, fatigue, perspiration, paresthesias, osteoarthralgia according to a five-point score scale (0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe).
Analysis population: FAS comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study
Groups in this outcome
Pasireotide LAR Overall - Acromegaly Symptom: Headache
This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue
This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration
This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia
This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae
This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg
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 Overall - Acromegaly Symptom: Headache
123
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue
123
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration
123
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia
123
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae
123
Reported measurements
Baseline (BL): Non/absent
Analysis denominator · Participants
Group
Source count
Pasireotide LAR Overall - Acromegaly Symptom: Headache
51
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue
45
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration
53
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia
41
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae
67
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR Overall - Acromegaly Symptom: Headache
41.5
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue
36.6
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration
43.1
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia
33.3
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae
54.5
Not reported
Not reported
Not reported
Not reported
BL: Mild
Analysis denominator · Participants
Group
Source count
Pasireotide LAR Overall - Acromegaly Symptom: Headache
31
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue
23
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration
31
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia
26
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae
31
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR Overall - Acromegaly Symptom: Headache
25.2
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue
17.8
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration
25.2
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia
21.1
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae
25.2
Not reported
Not reported
Not reported
Not reported
BL: Moderate
Analysis denominator · Participants
Group
Source count
Pasireotide LAR Overall - Acromegaly Symptom: Headache
23
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue
32
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration
23
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia
32
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae
13
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR Overall - Acromegaly Symptom: Headache
18.7
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue
26.0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration
18.7
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia
26.0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae
10.6
Not reported
Not reported
Not reported
Not reported
BL: Severe
Analysis denominator · Participants
Group
Source count
Pasireotide LAR Overall - Acromegaly Symptom: Headache
11
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue
17
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration
11
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia
20
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae
11
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR Overall - Acromegaly Symptom: Headache
7
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue
13.8
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration
8.9
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia
16.3
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae
8.9
Not reported
Not reported
Not reported
Not reported
BL: Very severe
Analysis denominator · Participants
Group
Source count
Pasireotide LAR Overall - Acromegaly Symptom: Headache
7
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue
6
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration
5
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia
4
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae
1
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR Overall - Acromegaly Symptom: Headache
5.7
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue
4.9
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration
4.1
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia
3.3
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae
0.8
Not reported
Not reported
Not reported
Not reported
BL: Not done
Analysis denominator · Participants
Group
Source count
Pasireotide LAR Overall - Acromegaly Symptom: Headache
0
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue
0
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration
0
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia
0
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae
0
BL: Total
Analysis denominator · Participants
Group
Source count
Pasireotide LAR Overall - Acromegaly Symptom: Headache
123
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue
123
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration
123
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia
123
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae
123
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR Overall - Acromegaly Symptom: Headache
100.0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue
100.0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration
100.0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia
100.0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae
100.0
Not reported
Not reported
Not reported
Not reported
Most extr post-BL:tot Non/absent
Analysis denominator · Participants
Group
Source count
Pasireotide LAR Overall - Acromegaly Symptom: Headache
45
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue
32
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration
46
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia
33
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae
58
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR Overall - Acromegaly Symptom: Headache
36.6
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue
26.0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration
37.4
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia
26.8
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae
47.2
Not reported
Not reported
Not reported
Not reported
Most extr. post-BL: total Mild
Analysis denominator · Participants
Group
Source count
Pasireotide LAR Overall - Acromegaly Symptom: Headache
38
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue
28
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration
36
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia
32
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae
34
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR Overall - Acromegaly Symptom: Headache
30.9
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue
22.8
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration
29.3
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia
26.0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae
27.6
Not reported
Not reported
Not reported
Not reported
Most extr. post-BL: total Mod.
Analysis denominator · Participants
Group
Source count
Pasireotide LAR Overall - Acromegaly Symptom: Headache
25
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue
28
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration
25
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia
30
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae
16
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR Overall - Acromegaly Symptom: Headache
20.3
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue
22.8
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration
20.3
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia
24.4
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae
13.0
Not reported
Not reported
Not reported
Not reported
Most extr. post-BL: total Severe
Analysis denominator · Participants
Group
Source count
Pasireotide LAR Overall - Acromegaly Symptom: Headache
12
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue
19
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration
9
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia
18
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae
12
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR Overall - Acromegaly Symptom: Headache
9.8
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue
15.4
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration
7.3
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia
14.6
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae
9.8
Not reported
Not reported
Not reported
Not reported
Most extr post-BL:tot. Very severe
Analysis denominator · Participants
Group
Source count
Pasireotide LAR Overall - Acromegaly Symptom: Headache
3
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue
16
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration
7
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia
10
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae
3
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR Overall - Acromegaly Symptom: Headache
2.4
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue
13.0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration
5.7
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia
8.1
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae
2.4
Not reported
Not reported
Not reported
Not reported
Most extr. post-BL: total Not done
Analysis denominator · Participants
Group
Source count
Pasireotide LAR Overall - Acromegaly Symptom: Headache
0
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue
0
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration
0
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia
0
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae
0
Complete source fields
classes
categories
measurements
group Id
OG000
value
41.5
group Id
OG001
value
36.6
group Id
OG002
value
43.1
group Id
OG003
value
33.3
group Id
OG004
value
54.5
denoms
counts
group Id
OG000
value
51
group Id
OG001
value
45
group Id
OG002
value
53
group Id
OG003
value
41
group Id
OG004
value
67
units
Participants
title
Baseline (BL): Non/absent
categories
measurements
group Id
OG000
value
25.2
group Id
OG001
value
17.8
group Id
OG002
value
25.2
group Id
OG003
value
21.1
group Id
OG004
value
25.2
denoms
counts
group Id
OG000
value
31
group Id
OG001
value
23
group Id
OG002
value
31
group Id
OG003
value
26
group Id
OG004
value
31
units
Participants
title
BL: Mild
categories
measurements
group Id
OG000
value
18.7
group Id
OG001
value
26.0
group Id
OG002
value
18.7
group Id
OG003
value
26.0
group Id
OG004
value
10.6
denoms
counts
group Id
OG000
value
23
group Id
OG001
value
32
group Id
OG002
value
23
group Id
OG003
value
32
group Id
OG004
value
13
units
Participants
title
BL: Moderate
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
13.8
group Id
OG002
value
8.9
group Id
OG003
value
16.3
group Id
OG004
value
8.9
denoms
counts
group Id
OG000
value
11
group Id
OG001
value
17
group Id
OG002
value
11
group Id
OG003
value
20
group Id
OG004
value
11
units
Participants
title
BL: Severe
categories
measurements
group Id
OG000
value
5.7
group Id
OG001
value
4.9
group Id
OG002
value
4.1
group Id
OG003
value
3.3
group Id
OG004
value
0.8
denoms
counts
group Id
OG000
value
7
group Id
OG001
value
6
group Id
OG002
value
5
group Id
OG003
value
4
group Id
OG004
value
1
units
Participants
title
BL: Very severe
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
units
Participants
title
BL: Not done
categories
measurements
group Id
OG000
value
100.0
group Id
OG001
value
100.0
group Id
OG002
value
100.0
group Id
OG003
value
100.0
group Id
OG004
value
100.0
denoms
counts
group Id
OG000
value
123
group Id
OG001
value
123
group Id
OG002
value
123
group Id
OG003
value
123
group Id
OG004
value
123
units
Participants
title
BL: Total
categories
measurements
group Id
OG000
value
36.6
group Id
OG001
value
26.0
group Id
OG002
value
37.4
group Id
OG003
value
26.8
group Id
OG004
value
47.2
denoms
counts
group Id
OG000
value
45
group Id
OG001
value
32
group Id
OG002
value
46
group Id
OG003
value
33
group Id
OG004
value
58
units
Participants
title
Most extr post-BL:tot Non/absent
categories
measurements
group Id
OG000
value
30.9
group Id
OG001
value
22.8
group Id
OG002
value
29.3
group Id
OG003
value
26.0
group Id
OG004
value
27.6
denoms
counts
group Id
OG000
value
38
group Id
OG001
value
28
group Id
OG002
value
36
group Id
OG003
value
32
group Id
OG004
value
34
units
Participants
title
Most extr. post-BL: total Mild
categories
measurements
group Id
OG000
value
20.3
group Id
OG001
value
22.8
group Id
OG002
value
20.3
group Id
OG003
value
24.4
group Id
OG004
value
13.0
denoms
counts
group Id
OG000
value
25
group Id
OG001
value
28
group Id
OG002
value
25
group Id
OG003
value
30
group Id
OG004
value
16
units
Participants
title
Most extr. post-BL: total Mod.
categories
measurements
group Id
OG000
value
9.8
group Id
OG001
value
15.4
group Id
OG002
value
7.3
group Id
OG003
value
14.6
group Id
OG004
value
9.8
denoms
counts
group Id
OG000
value
12
group Id
OG001
value
19
group Id
OG002
value
9
group Id
OG003
value
18
group Id
OG004
value
12
units
Participants
title
Most extr. post-BL: total Severe
categories
measurements
group Id
OG000
value
2.4
group Id
OG001
value
13.0
group Id
OG002
value
5.7
group Id
OG003
value
8.1
group Id
OG004
value
2.4
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
16
group Id
OG002
value
7
group Id
OG003
value
10
group Id
OG004
value
3
units
Participants
title
Most extr post-BL:tot. Very severe
denoms
counts
group Id
OG000
value
123
group Id
OG001
value
123
group Id
OG002
value
123
group Id
OG003
value
123
group Id
OG004
value
123
units
Participants
description
Symptoms of acromegaly were collected at various visits. The measurement was to be provided on a scale of 1-15 including half sizes. Investigators asked the participants to score the following symptoms of acromegaly: headache, fatigue, perspiration, paresthesias, osteoarthralgia according to a five-point score scale (0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe).
groups
description
This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.
id
OG000
title
Pasireotide LAR Overall - Acromegaly Symptom: Headache
description
This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg
id
OG001
title
Pasireotide LAR Overall - Acromegaly Symptom: Fatigue
description
This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg.
id
OG002
title
Pasireotide LAR Overall - Acromegaly Symptom: Perspiration
description
This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg
id
OG003
title
Pasireotide LAR Overall - Acromegaly Symptom: Osteoarthralgia
description
This is the sum total of participants in under the previous treatments: lanreotide 120 mg, octreotide 30 mg or octreotide 40 mg
id
OG004
title
Pasireotide LAR Overall - Acromegaly Symptom: Paresthsiae
param Type
NUMBER
population Description
FAS comprised all patients who had signed informed consent and had been treated with at least one dose of study medication (pasireotide LAR) after enrollment into the study
reporting Status
POSTED
time Frame
Weeks 12, 24 & 36
title
Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline