Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase)
Efficacy and Safety of Pasireotide LAR (Long-acting Release) in Japanese Patients With Acromegaly or Pituitary Gigantism · Source last updated 2019-09-16
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
12 Months (Core phase)
What was measured
Number of participants with a change of clinical signs from baseline (BL): headache (HA), fatigue (FA), perspiration (PE), paresthesias (PA), osteoarthralgia (OS)
Analysis population: Full analysis set (FAS) comprises all patients to whom study treatment has been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the study treatment they have been assigned to during the randomization procedure.
Groups in this outcome
Pasireotide LAR 20mg
Enrolled patients were randomized to 20mg pasireotide LAR.
Pasireotide LAR 40mg
Enrolled patients were randomized to 40mg pasireotide LAR.
Pasireotide LAR 60mg
Enrolled patients were randomized to 60mg pasireotide LAR.
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 20mg
11
Pasireotide LAR 40mg
11
Pasireotide LAR 60mg
11
Reported measurements
HA @ BL: non/absent
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
9
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
6
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
10
Not reported
Not reported
Not reported
Not reported
HA @ BL: mild
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
1
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
4
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
0
Not reported
Not reported
Not reported
Not reported
HA @ BL: moderate
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
1
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
0
Not reported
Not reported
Not reported
Not reported
HA @ BL: severe
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
1
Not reported
Not reported
Not reported
Not reported
HA @ BL: very severe
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
1
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
0
Not reported
Not reported
Not reported
Not reported
HA @ BL: total (all categories)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
11
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
11
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
11
Not reported
Not reported
Not reported
Not reported
HA @ most extreme post-BL: total non/absent
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
8
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
8
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
7
Not reported
Not reported
Not reported
Not reported
HA @ most extreme post-BL: total mild
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
3
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
2
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
3
Not reported
Not reported
Not reported
Not reported
HA @ most extreme post-BL: total moderate
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
1
Not reported
Not reported
Not reported
Not reported
HA @ most extreme post-BL: total severe
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
1
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
0
Not reported
Not reported
Not reported
Not reported
HA @ most extreme post-BL: total very severe
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
0
Not reported
Not reported
Not reported
Not reported
HA @ most extreme post-BL: total (all categories)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
11
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
11
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
11
Not reported
Not reported
Not reported
Not reported
FA @ BL: non/absent
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
7
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
5
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
6
Not reported
Not reported
Not reported
Not reported
FA @ BL: mild
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
3
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
3
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
2
Not reported
Not reported
Not reported
Not reported
FA @ BL: moderate
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
1
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
2
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
3
Not reported
Not reported
Not reported
Not reported
FA @ BL: severe
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
1
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
0
Not reported
Not reported
Not reported
Not reported
FA @ BL: very severe
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
0
Not reported
Not reported
Not reported
Not reported
FA @ BL: total (all categories)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
11
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
11
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
11
Not reported
Not reported
Not reported
Not reported
FA @ most extreme post-BL: total non/absent
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
4
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
3
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
5
Not reported
Not reported
Not reported
Not reported
FA @ most extreme post-BL: total mild
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
4
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
5
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
4
Not reported
Not reported
Not reported
Not reported
FA @ most extreme post-BL: total moderate
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
3
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
3
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
1
Not reported
Not reported
Not reported
Not reported
FA @ most extreme post-BL: total severe
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
1
Not reported
Not reported
Not reported
Not reported
FA @ most extreme post-BL: total very severe
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
0
Not reported
Not reported
Not reported
Not reported
FA @ most extreme post-BL: total (all categories)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
11
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
11
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
11
Not reported
Not reported
Not reported
Not reported
PE @ BL: non/absent
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
6
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
6
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
3
Not reported
Not reported
Not reported
Not reported
PE @ BL: mild
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
5
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
3
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
6
Not reported
Not reported
Not reported
Not reported
PE @ BL: moderate
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
2
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
2
Not reported
Not reported
Not reported
Not reported
PE @ BL: severe
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
0
Not reported
Not reported
Not reported
Not reported
PE @ BL: very severe
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
0
Not reported
Not reported
Not reported
Not reported
PE @ BL: total (all categories)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
11
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
11
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
11
Not reported
Not reported
Not reported
Not reported
PE @ most extreme post-BL: total non/absent
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
5
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
7
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
7
Not reported
Not reported
Not reported
Not reported
PE @ most extreme post-BL: total mild
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
5
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
2
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
3
Not reported
Not reported
Not reported
Not reported
PE @ most extreme post-BL: total moderate
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
1
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
1
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
0
Not reported
Not reported
Not reported
Not reported
PE @ most extreme post-BL: total severe
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
1
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
1
Not reported
Not reported
Not reported
Not reported
PE @ most extreme post-BL: total very severe
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
0
Not reported
Not reported
Not reported
Not reported
PE @ most extreme post-BL: total (all categories)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
11
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
11
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
11
Not reported
Not reported
Not reported
Not reported
OS @ BL: non/absent
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
9
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
5
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
7
Not reported
Not reported
Not reported
Not reported
OS @ BL: mild
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
1
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
1
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
3
Not reported
Not reported
Not reported
Not reported
OS @ BL: moderate
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
1
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
2
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
1
Not reported
Not reported
Not reported
Not reported
OS @ BL: severe
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
2
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
0
Not reported
Not reported
Not reported
Not reported
OS @ BL: very severe
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
1
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
0
Not reported
Not reported
Not reported
Not reported
OS @ BL: total (all categories)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
11
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
11
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
11
Not reported
Not reported
Not reported
Not reported
OS @ most extreme post-BL: total non/absent
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
8
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
5
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
6
Not reported
Not reported
Not reported
Not reported
OS @ most extreme post-BL: total mild
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
1
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
2
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
3
Not reported
Not reported
Not reported
Not reported
OS @ most extreme post-BL: total moderate
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
2
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
2
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
1
Not reported
Not reported
Not reported
Not reported
OS @ most extreme post-BL: total severe
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
1
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
1
Not reported
Not reported
Not reported
Not reported
OS @ most extreme post-BL: total very severe
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
1
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
0
Not reported
Not reported
Not reported
Not reported
OS @ most extreme post-BL: total (all categories)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
11
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
11
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
11
Not reported
Not reported
Not reported
Not reported
PA @ BL: non/absent
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
9
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
11
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
9
Not reported
Not reported
Not reported
Not reported
PA @ BL: mild
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
2
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
1
Not reported
Not reported
Not reported
Not reported
PA @ BL: moderate
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
1
Not reported
Not reported
Not reported
Not reported
PA @ BL: severe
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
0
Not reported
Not reported
Not reported
Not reported
PA @ BL: very severe
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
0
Not reported
Not reported
Not reported
Not reported
PA @ BL: total (all categories)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
11
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
11
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
11
Not reported
Not reported
Not reported
Not reported
PA @ most extreme post-BL: total non/absent
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
7
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
9
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
9
Not reported
Not reported
Not reported
Not reported
PA @ most extreme post-BL: total mild
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
4
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
1
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
1
Not reported
Not reported
Not reported
Not reported
PA @ most extreme post-BL: total moderate
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
1
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
1
Not reported
Not reported
Not reported
Not reported
PA @ most extreme post-BL: total severe
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
0
Not reported
Not reported
Not reported
Not reported
PA @ most extreme post-BL: total very severe
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
0
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
0
Not reported
Not reported
Not reported
Not reported
PA @ most extreme post-BL: total (all categories)
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pasireotide LAR 20mg
11
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 40mg
11
Not reported
Not reported
Not reported
Not reported
Pasireotide LAR 60mg
11
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
9
group Id
OG001
value
6
group Id
OG002
value
10
title
HA @ BL: non/absent
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
4
group Id
OG002
value
0
title
HA @ BL: mild
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
0
title
HA @ BL: moderate
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
title
HA @ BL: severe
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
title
HA @ BL: very severe
categories
measurements
group Id
OG000
value
11
group Id
OG001
value
11
group Id
OG002
value
11
title
HA @ BL: total (all categories)
categories
measurements
group Id
OG000
value
8
group Id
OG001
value
8
group Id
OG002
value
7
title
HA @ most extreme post-BL: total non/absent
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
2
group Id
OG002
value
3
title
HA @ most extreme post-BL: total mild
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
title
HA @ most extreme post-BL: total moderate
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
title
HA @ most extreme post-BL: total severe
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
title
HA @ most extreme post-BL: total very severe
categories
measurements
group Id
OG000
value
11
group Id
OG001
value
11
group Id
OG002
value
11
title
HA @ most extreme post-BL: total (all categories)
denoms
counts
group Id
OG000
value
11
group Id
OG001
value
11
group Id
OG002
value
11
units
Participants
description
Number of participants with a change of clinical signs from baseline (BL): headache (HA), fatigue (FA), perspiration (PE), paresthesias (PA), osteoarthralgia (OS)
groups
description
Enrolled patients were randomized to 20mg pasireotide LAR.
id
OG000
title
Pasireotide LAR 20mg
description
Enrolled patients were randomized to 40mg pasireotide LAR.
id
OG001
title
Pasireotide LAR 40mg
description
Enrolled patients were randomized to 60mg pasireotide LAR.
id
OG002
title
Pasireotide LAR 60mg
param Type
COUNT_OF_PARTICIPANTS
population Description
Full analysis set (FAS) comprises all patients to whom study treatment has been assigned by randomization. According to the intent to treat principle, patients were analyzed according to the study treatment they have been assigned to during the randomization procedure.
reporting Status
POSTED
time Frame
12 Months (Core phase)
title
Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase)
Triangle