Trial Outcomes & Findings for Study of the Efficacy and Safety of Pasireotide s.c. +/- Cabergoline in Patients With Cushing's Disease (NCT NCT01915303)
NCT ID: NCT01915303
Last Updated: 2020-09-18
Results Overview
Participants who attained mUFC ≤ 1.0 x ULN (upper limit of normal) with pasireotide alone or in combination with cabergoline. The 24h-UFC concentration results from three samples, collected during the screening period, were averaged to obtain the Baseline urinary free cortisol level. mean 24h-UFC was determined from two 24-hour urine collections collected on two consecutive days that occurred before the visit. Imputation: subjects who completed the end of treatment visit at Week 35, but had missing evaluation of mean urinary free cortisol (mUFC). The last available mUFC assessment at or after previous visit (week) before last week was carried forward as the last week mUFC assessment.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
Baseline up to week 35
Results posted on
2020-09-18
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Core Phase
STARTED
|
68
|
|
Core Phase
COMPLETED
|
52
|
|
Core Phase
NOT COMPLETED
|
16
|
|
Extension Phase
STARTED
|
29
|
|
Extension Phase
COMPLETED
|
12
|
|
Extension Phase
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Core Phase
Adverse Event
|
7
|
|
Core Phase
Unsatisfactory therapeutic effect
|
3
|
|
Core Phase
Death
|
2
|
|
Core Phase
Protocol Violation
|
2
|
|
Core Phase
Abnormal lab value
|
1
|
|
Core Phase
Withdrawal by Subject
|
1
|
|
Extension Phase
Unsatisfactory therapeutic effect
|
8
|
|
Extension Phase
Withdrawal by Subject
|
4
|
|
Extension Phase
Adverse Event
|
3
|
|
Extension Phase
Death
|
1
|
|
Extension Phase
Protocol Violation
|
1
|
Baseline Characteristics
Study of the Efficacy and Safety of Pasireotide s.c. +/- Cabergoline in Patients With Cushing's Disease
Baseline characteristics by cohort
| Measure |
All Patients
n=68 Participants
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
|
|---|---|
|
Age, Customized
< 65 years
|
64 participants
n=5 Participants
|
|
Age, Customized
≥ 65 years
|
4 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
44 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 Participants
n=5 Participants
|
|
Cushing's disease status
De novo
|
10 Participants
n=5 Participants
|
|
Cushing's disease status
Persistent/recurrent
|
58 Participants
n=5 Participants
|
|
Clinical symptoms of facial rubor
None
|
10 Participants
n=5 Participants
|
|
Clinical symptoms of facial rubor
Mild
|
17 Participants
n=5 Participants
|
|
Clinical symptoms of facial rubor
Moderate
|
11 Participants
n=5 Participants
|
|
Clinical symptoms of facial rubor
Severe
|
4 Participants
n=5 Participants
|
|
Clinical symptoms of facial rubor
Not done
|
26 Participants
n=5 Participants
|
|
Clinical symptoms of hirsutism
None
|
13 Participants
n=5 Participants
|
|
Clinical symptoms of hirsutism
Mild
|
12 Participants
n=5 Participants
|
|
Clinical symptoms of hirsutism
Moderate
|
7 Participants
n=5 Participants
|
|
Clinical symptoms of hirsutism
Severe
|
3 Participants
n=5 Participants
|
|
Clinical symptoms of hirsutism
Not done
|
33 Participants
n=5 Participants
|
|
Clinical symptoms of striae
None
|
20 Participants
n=5 Participants
|
|
Clinical symptoms of striae
Mild
|
10 Participants
n=5 Participants
|
|
Clinical symptoms of striae
Moderate
|
4 Participants
n=5 Participants
|
|
Clinical symptoms of striae
Severe
|
8 Participants
n=5 Participants
|
|
Clinical symptoms of striae
Not done
|
26 Participants
n=5 Participants
|
|
Clinical symptoms of supraclavicular fat pad
None
|
8 Participants
n=5 Participants
|
|
Clinical symptoms of supraclavicular fat pad
Mild
|
17 Participants
n=5 Participants
|
|
Clinical symptoms of supraclavicular fat pad
Moderate
|
13 Participants
n=5 Participants
|
|
Clinical symptoms of supraclavicular fat pad
Severe
|
4 Participants
n=5 Participants
|
|
Clinical symptoms of supraclavicular fat pad
Not done
|
26 Participants
n=5 Participants
|
|
Clinical symptoms of dorsal fat pad
None
|
3 Participants
n=5 Participants
|
|
Clinical symptoms of dorsal fat pad
Mild
|
19 Participants
n=5 Participants
|
|
Clinical symptoms of dorsal fat pad
Moderate
|
14 Participants
n=5 Participants
|
|
Clinical symptoms of dorsal fat pad
Severe
|
6 Participants
n=5 Participants
|
|
Clinical symptoms of dorsal fat pad
Not done
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to week 35Population: Full analysis set
Participants who attained mUFC ≤ 1.0 x ULN (upper limit of normal) with pasireotide alone or in combination with cabergoline. The 24h-UFC concentration results from three samples, collected during the screening period, were averaged to obtain the Baseline urinary free cortisol level. mean 24h-UFC was determined from two 24-hour urine collections collected on two consecutive days that occurred before the visit. Imputation: subjects who completed the end of treatment visit at Week 35, but had missing evaluation of mean urinary free cortisol (mUFC). The last available mUFC assessment at or after previous visit (week) before last week was carried forward as the last week mUFC assessment.
Outcome measures
| Measure |
All Patients
n=68 Participants
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
|
|---|---|
|
Percentage of Responders With Mean Urinary Free Cortisol (mUFC) ≤ 1.0xULN Collected or Imputed at Week 35
|
50.0 percentage of responders
Interval 37.6 to 62.4
|
SECONDARY outcome
Timeframe: Baseline, weeks 2, 4, every 4 or 5 weeks during core, every 8 weeks during extensionPopulation: Full analysis set. The data beyond Week 139 should be interpreted with caution given that small number of subjects were monitored
Mean value of mUFC at each scheduled visit was determined from two 24-hour urine collections collected on two consecutive days that occurred before the visit when UFC was measured.
Outcome measures
| Measure |
All Patients
n=68 Participants
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
|
|---|---|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Baseline
|
501.6 nmol/24h
Standard Deviation 488.66
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Core Week 2 n-8
|
217.0 nmol/24h
Standard Deviation 100.69
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Core Week 4 n=59
|
242.1 nmol/24h
Standard Deviation 203.47
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Core Week 8 n=58
|
230.0 nmol/24h
Standard Deviation 195.21
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Core Week 13 n=51
|
231.0 nmol/24h
Standard Deviation 240.98
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Core Week 17 n=57
|
310.3 nmol/24h
Standard Deviation 429.64
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Core Week 22 n=50
|
214.0 nmol/24h
Standard Deviation 202.80
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Core Week 26 n=54
|
211.6 nmol/24h
Standard Deviation 173.58
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Core Week 31 n=46
|
154.3 nmol/24h
Standard Deviation 104.16
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Core Week 35 n=45
|
184.8 nmol/24h
Standard Deviation 140.13
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Ext Week 43 n=22
|
136.1 nmol/24h
Standard Deviation 91.13
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Ext Week 51 n=20
|
156.8 nmol/24h
Standard Deviation 108.91
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Ext Week 59 n=24
|
157.7 nmol/24h
Standard Deviation 111.63
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Ext Week 67 n=17
|
213.8 nmol/24h
Standard Deviation 194.99
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Ext Week 75 n=18
|
157.6 nmol/24h
Standard Deviation 166.28
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Ext Week 83 n=20
|
157.9 nmol/24h
Standard Deviation 134.98
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Ext Week 91 n=18
|
180.0 nmol/24h
Standard Deviation 302.36
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Ext Week 99 n=13
|
222.5 nmol/24h
Standard Deviation 375.67
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Ext Week 107 n=12
|
118.5 nmol/24h
Standard Deviation 122.01
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Ext Week 115 n=13
|
126.0 nmol/24h
Standard Deviation 80.09
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Ext Week 123 n=13
|
147.5 nmol/24h
Standard Deviation 157.77
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Ext Week 131 n=11
|
76.4 nmol/24h
Standard Deviation 49.92
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Ext Week 139 n=9
|
92.9 nmol/24h
Standard Deviation 73.18
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Ext Week 147 n=9
|
90.1 nmol/24h
Standard Deviation 55.31
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Ext Week 155 n=4
|
76.3 nmol/24h
Standard Deviation 39.05
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Ext Week 163 n=6
|
141.1 nmol/24h
Standard Deviation 142.42
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Ext Week 171 n=6
|
89.5 nmol/24h
Standard Deviation 61.87
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Ext Week 179 n=4
|
61.3 nmol/24h
Standard Deviation 43.06
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Ext Week 187 n=4
|
89.9 nmol/24h
Standard Deviation 52.44
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Ext Week 195 n=3
|
46.1 nmol/24h
Standard Deviation 40.21
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Ext Week 203 n=4
|
194.0 nmol/24h
Standard Deviation 259.15
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Ext Week 211 n=3
|
107.3 nmol/24h
Standard Deviation 37.68
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Ext Week 219 n=2
|
70.6 nmol/24h
Standard Deviation 46.74
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Ext Week 227 n=2
|
47.1 nmol/24h
Standard Deviation 7.99
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Ext Week 235 n=3
|
62.0 nmol/24h
Standard Deviation 23.83
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Ext Week 243 n=1
|
117.7 nmol/24h
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Ext Week 251 n=1
|
202.9 nmol/24h
|
|
Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
Ext Week 267 n=1
|
249.0 nmol/24h
|
SECONDARY outcome
Timeframe: Baseline up to week 235Population: Full analysis set. The data beyond Week 139 should be interpreted with caution given that small number of subjects were monitored
Actual mean value of mUFC at each scheduled visit was determined from two 24-hour urine collections collected on two consecutive days that occurred before the visit when UFC was measured.
Outcome measures
| Measure |
All Patients
n=68 Participants
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
|
|---|---|
|
Percentage of Responders With Mean Urinary Free Cortisol (mUFC) ≤ 1.0xULN
Baseline
|
4.4 percentage of responders
Interval 0.9 to 12.4
|
|
Percentage of Responders With Mean Urinary Free Cortisol (mUFC) ≤ 1.0xULN
Core Week 17 n=57
|
28.1 percentage of responders
Interval 17.0 to 41.5
|
|
Percentage of Responders With Mean Urinary Free Cortisol (mUFC) ≤ 1.0xULN
Core Week 35 n=45
|
48.9 percentage of responders
Interval 33.7 to 64.2
|
|
Percentage of Responders With Mean Urinary Free Cortisol (mUFC) ≤ 1.0xULN
Ext Week 43 n=22
|
63.6 percentage of responders
Interval 40.7 to 82.8
|
|
Percentage of Responders With Mean Urinary Free Cortisol (mUFC) ≤ 1.0xULN
Ext Week 67 n=17
|
47.1 percentage of responders
Interval 23.0 to 72.2
|
|
Percentage of Responders With Mean Urinary Free Cortisol (mUFC) ≤ 1.0xULN
Ext Week 91 n=18
|
61.1 percentage of responders
Interval 35.7 to 82.7
|
|
Percentage of Responders With Mean Urinary Free Cortisol (mUFC) ≤ 1.0xULN
Ext Week 115 n=13
|
76.9 percentage of responders
Interval 46.2 to 95.0
|
|
Percentage of Responders With Mean Urinary Free Cortisol (mUFC) ≤ 1.0xULN
Ext Week 139 n=9
|
77.8 percentage of responders
Interval 40.0 to 97.2
|
|
Percentage of Responders With Mean Urinary Free Cortisol (mUFC) ≤ 1.0xULN
Ext Week 163 n=6
|
66.7 percentage of responders
Interval 22.3 to 95.7
|
|
Percentage of Responders With Mean Urinary Free Cortisol (mUFC) ≤ 1.0xULN
Ext Week 187 n=4
|
75.0 percentage of responders
Interval 19.4 to 99.4
|
|
Percentage of Responders With Mean Urinary Free Cortisol (mUFC) ≤ 1.0xULN
Ext Week 211 n=3
|
66.7 percentage of responders
Interval 9.4 to 99.2
|
|
Percentage of Responders With Mean Urinary Free Cortisol (mUFC) ≤ 1.0xULN
Ext Week 235 n=3
|
100 percentage of responders
Interval 29.2 to 100.0
|
SECONDARY outcome
Timeframe: Baseline up to week 235Population: Full analysis set. The data beyond Week 139 should be interpreted with caution given that small number of subjects were monitored
Actual mean value of mUFC at each scheduled visit was determined from two 24-hour urine collections collected on two consecutive days that occurred before the visit when UFC was measured.
Outcome measures
| Measure |
All Patients
n=68 Participants
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
|
|---|---|
|
Percentage of Participants Who Attain mUFC ≤ 1.0 x ULN or Have at Least 50% Reduction From Baseline in mUFC
Baseline
|
4.4 percentage of responders
Interval 0.9 to 12.4
|
|
Percentage of Participants Who Attain mUFC ≤ 1.0 x ULN or Have at Least 50% Reduction From Baseline in mUFC
Core Week 17 n=57
|
54.4 percentage of responders
Interval 40.7 to 67.6
|
|
Percentage of Participants Who Attain mUFC ≤ 1.0 x ULN or Have at Least 50% Reduction From Baseline in mUFC
Core Week 35 n=45
|
68.9 percentage of responders
Interval 53.4 to 81.8
|
|
Percentage of Participants Who Attain mUFC ≤ 1.0 x ULN or Have at Least 50% Reduction From Baseline in mUFC
Ext Week 43 n=22
|
86.4 percentage of responders
Interval 65.1 to 97.1
|
|
Percentage of Participants Who Attain mUFC ≤ 1.0 x ULN or Have at Least 50% Reduction From Baseline in mUFC
Ext Week 67 n=17
|
76.5 percentage of responders
Interval 50.1 to 93.2
|
|
Percentage of Participants Who Attain mUFC ≤ 1.0 x ULN or Have at Least 50% Reduction From Baseline in mUFC
Ext Week 91 n=18
|
83.3 percentage of responders
Interval 58.6 to 96.4
|
|
Percentage of Participants Who Attain mUFC ≤ 1.0 x ULN or Have at Least 50% Reduction From Baseline in mUFC
Ext Week 115 n=13
|
92.3 percentage of responders
Interval 64.0 to 99.8
|
|
Percentage of Participants Who Attain mUFC ≤ 1.0 x ULN or Have at Least 50% Reduction From Baseline in mUFC
Ext Week 139 n=9
|
77.8 percentage of responders
Interval 40.0 to 97.2
|
|
Percentage of Participants Who Attain mUFC ≤ 1.0 x ULN or Have at Least 50% Reduction From Baseline in mUFC
Ext Week 163 n=6
|
83.3 percentage of responders
Interval 35.9 to 99.6
|
|
Percentage of Participants Who Attain mUFC ≤ 1.0 x ULN or Have at Least 50% Reduction From Baseline in mUFC
Ext Week 187 n=4
|
100 percentage of responders
Interval 39.8 to 100.0
|
|
Percentage of Participants Who Attain mUFC ≤ 1.0 x ULN or Have at Least 50% Reduction From Baseline in mUFC
Ext Week 211 n=3
|
66.7 percentage of responders
Interval 9.4 to 99.2
|
|
Percentage of Participants Who Attain mUFC ≤ 1.0 x ULN or Have at Least 50% Reduction From Baseline in mUFC
Ext Week 235 n=3
|
100 percentage of responders
Interval 29.2 to 100.0
|
SECONDARY outcome
Timeframe: from the date patient's first normalization (mUFC ≤ 1.0xULN) or at least 50% reduction from baseline up to the date when the patient's mUFC > 1.0 x ULNPopulation: Core and extension full analysis set
Duration of controlled or partially controlled response is defined as the period starting from the date of patient's first normalization (mUFC ≤ 1.0 x ULN) or at least 50% reduction from baseline up to the date when the patient's mUFC \> 1.0 x ULN and the reduction from baseline falls to less than 50% from the first time
Outcome measures
| Measure |
All Patients
n=68 Participants
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
|
|---|---|
|
Duration (Weeks) of Controlled or Partially Controlled Response
Core n=36
|
13.1 weeks
Interval 9.3 to 22.4
|
|
Duration (Weeks) of Controlled or Partially Controlled Response
Extension n=20
|
22.0 weeks
Interval 8.1 to 70.1
|
SECONDARY outcome
Timeframe: Baseline, weeks 2, 4, every 4 or 5 weeks during core, every 8 weeks during extensionPopulation: Full analysis set
A pre-dose blood draw for plasma ACTH sampling was taken at visits. Samples were analyzed by a central laboratory.
Outcome measures
| Measure |
All Patients
n=68 Participants
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
|
|---|---|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Baseline
|
16.3 pmol/L
Standard Deviation 16.3
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Core Week 2 n-62
|
12.4 pmol/L
Standard Deviation 9.91
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Core Week 4 n=63
|
14.2 pmol/L
Standard Deviation 12.50
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Core Week 8 n=61
|
13.3 pmol/L
Standard Deviation 11.90
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Core Week 13 n=53
|
11.9 pmol/L
Standard Deviation 10.98
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Core Week 17 n=58
|
12.3 pmol/L
Standard Deviation 9.03
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Core Week 22 n=49
|
13.7 pmol/L
Standard Deviation 13.82
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Core Week 26 n=55
|
12.4 pmol/L
Standard Deviation 12.09
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Core Week 31 n=49
|
12.1 pmol/L
Standard Deviation 11.02
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Core Week 35 n=40
|
11.0 pmol/L
Standard Deviation 8.71
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Ext Week 43 n=23
|
11.5 pmol/L
Standard Deviation 8.12
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Ext Week 51 n=21
|
10.4 pmol/L
Standard Deviation 6.80
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Ext Week 59 n=23
|
10.7 pmol/L
Standard Deviation 6.89
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Ext Week 67 n=22
|
11.0 pmol/L
Standard Deviation 7.23
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Ext Week 75 n=22
|
9.1 pmol/L
Standard Deviation 4.16
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Ext Week 83 n=19
|
9.8 pmol/L
Standard Deviation 8.20
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Ext Week 91 n=19
|
10.6 pmol/L
Standard Deviation 8.34
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Ext Week 99 n=16
|
11.3 pmol/L
Standard Deviation 8.50
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Ext Week 107 n=13
|
9.3 pmol/L
Standard Deviation 6.61
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Ext Week 115 n=15
|
9.5 pmol/L
Standard Deviation 7.22
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Ext Week 123 n=14
|
10.6 pmol/L
Standard Deviation 8.24
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Ext Week 131 n=12
|
8.2 pmol/L
Standard Deviation 6.01
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Ext Week 139 n=10
|
10.0 pmol/L
Standard Deviation 7.01
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Ext Week 147 n=9
|
10.4 pmol/L
Standard Deviation 7.02
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Ext Week 155 n=9
|
10.4 pmol/L
Standard Deviation 7.02
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Ext Week 163 n=5
|
10.0 pmol/L
Standard Deviation 4.85
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Ext Week 171 n=5
|
7.4 pmol/L
Standard Deviation 3.36
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Ext Week 179 n=5
|
7.0 pmol/L
Standard Deviation 3.32
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Ext Week 187 n=5
|
8.6 pmol/L
Standard Deviation 5.32
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Ext Week 195 n=4
|
9.0 pmol/L
Standard Deviation 4.76
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Ext Week 203 n=4
|
8.0 pmol/L
Standard Deviation 2.94
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Ext Week 211 n=3
|
11.0 pmol/L
Standard Deviation 4.58
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Ext Week 219 n=2
|
6.0 pmol/L
Standard Deviation 0.00
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Ext Week 227 n=2
|
7.0 pmol/L
Standard Deviation 1.41
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Ext Week 235 n=3
|
10.3 pmol/L
Standard Deviation 3.21
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Ext Week 243 n=1
|
6.0 pmol/L
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Ext Week 251 n=1
|
7.0 pmol/L
|
|
Plasma Adrenocorticotropic Hormone (ACTH)
Ext Week 267 n=1
|
4.0 pmol/L
|
SECONDARY outcome
Timeframe: Baseline, weeks 2, 4, every 4 or 5 weeks during core, every 8 weeks during extensionPopulation: Full analysis set
A pre-dose blood draw for an 8 am fasting serum cortisol measurement were taken at visits. Samples were analyzed by a central laboratory.
Outcome measures
| Measure |
All Patients
n=68 Participants
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
|
|---|---|
|
Serum Cortisol Levels
Ext Week 267 n=1
|
638.0 nmol/L
|
|
Serum Cortisol Levels
Baseline
|
738.6 nmol/L
Standard Deviation 332.53
|
|
Serum Cortisol Levels
Core Week 2 n-62
|
626.1 nmol/L
Standard Deviation 281.57
|
|
Serum Cortisol Levels
Core Week 4 n=64
|
663.6 nmol/L
Standard Deviation 292.38
|
|
Serum Cortisol Levels
Core Week 8 n=61
|
649.0 nmol/L
Standard Deviation 297.11
|
|
Serum Cortisol Levels
Core Week 13 n=53
|
628.8 nmol/L
Standard Deviation 269.43
|
|
Serum Cortisol Levels
Core Week 17 n=58
|
683.0 nmol/L
Standard Deviation 282.28
|
|
Serum Cortisol Levels
Core Week 22 n=49
|
625.4 nmol/L
Standard Deviation 216.29
|
|
Serum Cortisol Levels
Core Week 26 n=55
|
632.7 nmol/L
Standard Deviation 278.75
|
|
Serum Cortisol Levels
Core Week 31 n=49
|
597.5 nmol/L
Standard Deviation 247.60
|
|
Serum Cortisol Levels
Core Week 35 n=40
|
538.2 nmol/L
Standard Deviation 205.40
|
|
Serum Cortisol Levels
Ext Week 43 n=23
|
525.5 nmol/L
Standard Deviation 178.63
|
|
Serum Cortisol Levels
Ext Week 51 n=21
|
512.2 nmol/L
Standard Deviation 243.59
|
|
Serum Cortisol Levels
Ext Week 59 n=21
|
547.5 nmol/L
Standard Deviation 193.67
|
|
Serum Cortisol Levels
Ext Week 67 n=22
|
495.4 nmol/L
Standard Deviation 213.03
|
|
Serum Cortisol Levels
Ext Week 75 n=21
|
458.5 nmol/L
Standard Deviation 170.88
|
|
Serum Cortisol Levels
Ext Week 83 n=19
|
419.5 nmol/L
Standard Deviation 141.26
|
|
Serum Cortisol Levels
Ext Week 91 n=19
|
501.2 nmol/L
Standard Deviation 235.89
|
|
Serum Cortisol Levels
Ext Week 99 n=16
|
470.9 nmol/L
Standard Deviation 248.0
|
|
Serum Cortisol Levels
Ext Week 107 n=13
|
463.4 nmol/L
Standard Deviation 189.27
|
|
Serum Cortisol Levels
Ext Week 115 n=15
|
501.7 nmol/L
Standard Deviation 212.27
|
|
Serum Cortisol Levels
Ext Week 123 n=14
|
441.6 nmol/L
Standard Deviation 150.98
|
|
Serum Cortisol Levels
Ext Week 131 n=12
|
413.8 nmol/L
Standard Deviation 325.5
|
|
Serum Cortisol Levels
Ext Week 139 n=10
|
404.0 nmol/L
Standard Deviation 90.87
|
|
Serum Cortisol Levels
Ext Week 147 n=10
|
585.4 nmol/L
Standard Deviation 216.92
|
|
Serum Cortisol Levels
Ext Week 155 n=8
|
472.5 nmol/L
Standard Deviation 122.96
|
|
Serum Cortisol Levels
Ext Week 163 n=6
|
617.0 nmol/L
Standard Deviation 212.11
|
|
Serum Cortisol Levels
Ext Week 171 n=5
|
648.6 nmol/L
Standard Deviation 243.79
|
|
Serum Cortisol Levels
Ext Week 179 n=5
|
599.0 nmol/L
Standard Deviation 388.78
|
|
Serum Cortisol Levels
Ext Week 187 n=5
|
609.8 nmol/L
Standard Deviation 292.85
|
|
Serum Cortisol Levels
Ext Week 195 n=4
|
418.8 nmol/L
Standard Deviation 138.69
|
|
Serum Cortisol Levels
Ext Week 203 n=4
|
514.0 nmol/L
Standard Deviation 212.27
|
|
Serum Cortisol Levels
Ext Week 211 n=3
|
551.3 nmol/L
Standard Deviation 339.87
|
|
Serum Cortisol Levels
Ext Week 219 n=2
|
482.0 nmol/L
Standard Deviation 25.46
|
|
Serum Cortisol Levels
Ext Week 227 n=2
|
324.5 nmol/L
Standard Deviation 177.48
|
|
Serum Cortisol Levels
Ext Week 235 n=3
|
384.7 nmol/L
Standard Deviation 165.17
|
|
Serum Cortisol Levels
Ext Week 243 n=1
|
679.0 nmol/L
|
|
Serum Cortisol Levels
Ext Week 251 n=1
|
574.0 nmol/L
|
SECONDARY outcome
Timeframe: Baseline and week 35Population: Full analysis set
The mean arterial blood pressure determinations were obtained in the sitting position. Three measurements were taken with 5 minute intervals and the mean was used for study specific procedures
Outcome measures
| Measure |
All Patients
n=68 Participants
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
|
|---|---|
|
Sitting Systolic Blood Pressure at Week 35
Baseline
|
125.9 mmHg
Standard Deviation 14.3
|
|
Sitting Systolic Blood Pressure at Week 35
Week 35 n=41
|
119.5 mmHg
Standard Deviation 18.6
|
SECONDARY outcome
Timeframe: Baseline and week 35Population: Full analysis set
The mean arterial blood pressure determinations were obtained in the sitting position. Three measurements were taken with 5 minute intervals and the mean was used for study specific procedures
Outcome measures
| Measure |
All Patients
n=68 Participants
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
|
|---|---|
|
Sitting Diastolic Blood Pressure at Week 35
Baseline
|
81.8 mmHg
Standard Deviation 9.12
|
|
Sitting Diastolic Blood Pressure at Week 35
Week 35 n=41
|
77.2 mmHg
Standard Deviation 12.42
|
SECONDARY outcome
Timeframe: Baseline and week 35Population: Full analysis set
Weight was was one of the measures of clinical symptoms of CD
Outcome measures
| Measure |
All Patients
n=68 Participants
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
|
|---|---|
|
Body Weight at Week 35
Baseline
|
82.2 kg
Standard Deviation 19.1
|
|
Body Weight at Week 35
Week 35 n=41
|
75.6 kg
Standard Deviation 20.4
|
SECONDARY outcome
Timeframe: Baseline and week 35Population: Full analysis set
Body mass index was one of the measurements of clinical symptoms of CD. Body mass index=weight in kg divided by the square of the body height (in meters)
Outcome measures
| Measure |
All Patients
n=68 Participants
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
|
|---|---|
|
Body Mass Index at Week 35
Baseline
|
31.3 kg/m2
Standard Deviation 6.6
|
|
Body Mass Index at Week 35
Week 35 n=41
|
28.4 kg/m2
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: Baseline and week 35Population: Full analysis set
Waist circumference was one of the measurements of clinical signs of CD
Outcome measures
| Measure |
All Patients
n=68 Participants
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
|
|---|---|
|
Waist Circumference at Week 35
Week 35 n=41
|
99.1 cm
Standard Deviation 18.2
|
|
Waist Circumference at Week 35
Baseline
|
104.1 cm
Standard Deviation 19.1
|
SECONDARY outcome
Timeframe: Baseline and week 35Population: Full analysis set
LDL=Low density lipoprotein, HDL=high density llipoprotein and total protein were analyzed by a central laboratory
Outcome measures
| Measure |
All Patients
n=68 Participants
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
|
|---|---|
|
LDL, HDL and Total Cholesterol at Week 35
HDL Baseline
|
1.5 mmol/L
Standard Deviation 0.3
|
|
LDL, HDL and Total Cholesterol at Week 35
HDL Week 35 n=41
|
1.5 mmol/L
Standard Deviation 0.4
|
|
LDL, HDL and Total Cholesterol at Week 35
LDL Baseline
|
3.2 mmol/L
Standard Deviation 1.0
|
|
LDL, HDL and Total Cholesterol at Week 35
LDL Week 35 n=41
|
2.8 mmol/L
Standard Deviation 1.0
|
|
LDL, HDL and Total Cholesterol at Week 35
Total Baseline
|
69.4 mmol/L
Standard Deviation 3.7
|
|
LDL, HDL and Total Cholesterol at Week 35
Total Week 35 n=41
|
68.6 mmol/L
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: Baseline and week 17 and 35Population: Full analysis set
Patients who completed nine or more items for the 12-item Cushing's syndrome QoL questionaire were considered evaluable for that assessment. Raw scores were obtained for the 12 items using the following scoring: 1) always or very much, 2) often or quite a bit, 3) sometimes or somewhat, 4) rarely or very little, 5) never or not at all. Then the standardized score, Y, was calculated for each patient as follows: Y = 100\* (X - n) / n\*5 - n\*1) = 100 \* (X - n) / 4\*n where X denoted the raw score and n the number of questions answered by the patient. The higher the score, the better the QoL. The best possible standardized score was 100 and the worst possible standardized score was 0
Outcome measures
| Measure |
All Patients
n=68 Participants
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
|
|---|---|
|
Mean Scores of Cushing QoL Standardized Score at Week 17 and 35
Week 35 n=40
|
47.6 scores on a scale
Standard Deviation 20.8
|
|
Mean Scores of Cushing QoL Standardized Score at Week 17 and 35
Baseline Mean
|
41.6 scores on a scale
Standard Deviation 20.2
|
|
Mean Scores of Cushing QoL Standardized Score at Week 17 and 35
Week 17 n=54
|
46.3 scores on a scale
Standard Deviation 19.7
|
SECONDARY outcome
Timeframe: Baseline, week 17 and 35Population: Full analysis set
SF-12v2 General Health Survey is a general patient reported outcome instrument over time. It is scored to provide eight health domain scores (Bodily Pain (BP), General Health (GH), Physical Functioning (PF), Role-Physical (RP), Social Functioning (SF), Role-Emotional (RE), Vitality (VT) and Mental Health (MH)). These eight domain scores can be combined to form two summary scores reflecting overall physical and mental health: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The analyses reported here focus on PCS and MCS scores. The domain scores use a norm-based score, which standardizes the scores with respect to the mean and standard deviation of a nationally representative sample of United States (US) adults. These are the scores on the original scale which have not been transformed in any way. The possible range of scores is 0 to 100, with higher scores representing better outcomes.
Outcome measures
| Measure |
All Patients
n=68 Participants
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
|
|---|---|
|
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Week 35 n=40 Mental component
|
42.1 scores on a scale
Standard Deviation 8.32
|
|
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Baseline Bodily pain scale
|
42.9 scores on a scale
Standard Deviation 11.93
|
|
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Week 17 n=52 Bodily pain scale
|
45.1 scores on a scale
Standard Deviation 10.75
|
|
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Week 35 n=40 Bodily pain scale
|
44.9 scores on a scale
Standard Deviation 10.79
|
|
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Week 17 n=52 Mental health
|
43.0 scores on a scale
Standard Deviation 9.54
|
|
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Week 35 n=40 Mental health
|
42.4 scores on a scale
Standard Deviation 8.44
|
|
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Baseline n=67 Role emotional
|
39.7 scores on a scale
Standard Deviation 11.67
|
|
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Week 17 n=52 Role emotional
|
38.0 scores on a scale
Standard Deviation 9.95
|
|
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Week 35 n=40 Role emotional
|
38.7 scores on a scale
Standard Deviation 10.70
|
|
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Baseline n=67 Mental health
|
41.9 scores on a scale
Standard Deviation 10.48
|
|
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Baseline n=67 Role physical scale:
|
42.3 scores on a scale
Standard Deviation 10.45
|
|
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Week 17 n=52 Role physical scale:
|
42.8 scores on a scale
Standard Deviation 8.73
|
|
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Week 35 n=40 Role physical scale:
|
41.3 scores on a scale
Standard Deviation 9.63
|
|
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Baseline n=67 Social functioning
|
42.2 scores on a scale
Standard Deviation 11.22
|
|
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Week 17 n=52 Social functioning
|
43.0 scores on a scale
Standard Deviation 8.70
|
|
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Week 35 n=40 Social functioning
|
43.3 scores on a scale
Standard Deviation 9.66
|
|
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Baseline n=67 Vitality scale:
|
47.2 scores on a scale
Standard Deviation 10.02
|
|
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Week 17 n=52 Vitality scale:
|
45.7 scores on a scale
Standard Deviation 10.29
|
|
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Week 35 n=40 Vitality scale:
|
45.6 scores on a scale
Standard Deviation 8.78
|
|
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Baseline n=67 General health scale:
|
38.9 scores on a scale
Standard Deviation 9.23
|
|
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Week 17 n=52 General health scale:
|
40.9 scores on a scale
Standard Deviation 8.52
|
|
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Week 35 n=40 General health scale:
|
40.7 scores on a scale
Standard Deviation 8.94
|
|
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Baseline n=67 Mental component
|
42.4 scores on a scale
Standard Deviation 10.17
|
|
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Week 17 n=52 Mental component
|
41.9 scores on a scale
Standard Deviation 9.68
|
|
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Baseline n=67 Physical component summary
|
42.7 scores on a scale
Standard Deviation 9.03
|
|
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Week 17 n=52 Physical component summary
|
44.0 scores on a scale
Standard Deviation 8.52
|
|
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Week 35 n=40 Physical component summary
|
43.4 scores on a scale
Standard Deviation 9.59
|
|
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Baseline n=67 Physical functioning
|
42.1 scores on a scale
Standard Deviation 10.17
|
|
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Week 17 n=52 Physical functioning
|
41.9 scores on a scale
Standard Deviation 8.93
|
|
Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
Week 35 n=40 Physical functioning
|
42.1 scores on a scale
Standard Deviation 11.10
|
SECONDARY outcome
Timeframe: Baseline, weeks 2, 4, every 4 or 5 weeks during core, every 16 weeks during extensionPopulation: Full analysis set. The data beyond Week 139 should be interpreted with caution given that small number of subjects were monitored
Clinical symptoms include: facial rubor, hirsutism, striae, and supraclavicular and dorsal fat pad. Two photographs, one frontal and one lateral from the shoulders up were taken to assess facial plethora, supraclavicular and dorsal fat pads. Two photographs, frontal and dorsal of the trunk with patient in standing position were taken to assess striae, and hirsutism. The photographs were assessed by a qualified physician at the site. Improvement=decrease in severity of symptom since baseline
Outcome measures
| Measure |
All Patients
n=68 Participants
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
|
|---|---|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Facial Rubor
Ext Week 235 n=3
|
0 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Facial Rubor
Ext Week 251 n=1
|
0 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Facial Rubor
Ext Week 267 n=1
|
0 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Facial Rubor
Core Week 1 n=40
|
5 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Facial Rubor
Core Week 2 n=37
|
8 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Facial Rubor
Core Week 4 n=38
|
8 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Facial Rubor
Core Week 8 n=37
|
12 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Facial Rubor
Core Week 13 n=32
|
11 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Facial Rubor
Core Week 17 n=32
|
11 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Facial Rubor
Core Week 22 n=28
|
10 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Facial Rubor
Core Week 26 n=31
|
14 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Facial Rubor
Core Week 31 n=32
|
15 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Facial Rubor
Core Week 35 n=26
|
13 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Facial Rubor
Ext Week 43 n=11
|
2 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Facial Rubor
Ext Week 59 n=11
|
3 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Facial Rubor
Ext Week 75 n=12
|
3 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Facial Rubor
Ext Week 91 n=10
|
3 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Facial Rubor
Ext Week 107 n=9
|
3 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Facial Rubor
Ext Week 123 n=10
|
2 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Facial Rubor
Ext Week 139 n=7
|
2 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Facial Rubor
Ext Week 155 n=4
|
0 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Facial Rubor
Ext Week 171 n=3
|
0 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Facial Rubor
Ext Week 187 n=3
|
0 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Facial Rubor
Ext Week 203 n=4
|
0 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Facial Rubor
Ext Week 219 n=2
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, weeks 2, 4, every 4 or 5 weeks during core, every 16 weeks during extensionPopulation: Full analysis set. The data beyond Week 139 should be interpreted with caution given that small number of subjects were monitored
Clinical symptoms include: facial rubor, hirsutism, striae, and supraclavicular and dorsal fat pad. Two photographs, one frontal and one lateral from the shoulders up were taken to assess facial plethora, supraclavicular and dorsal fat pads. Two photographs, frontal and dorsal of the trunk with patient in standing position were taken to assess striae, and hirsutism. The photographs were assessed by a qualified physician at the site. Improvement=decrease in severity of symptom since baseline
Outcome measures
| Measure |
All Patients
n=68 Participants
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
|
|---|---|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Hirsutism
Ext Week 219 n=2
|
1 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Hirsutism
Ext Week 235 n=3
|
1 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Hirsutism
Ext Week 251 n=1
|
0 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Hirsutism
Ext Week 267 n=1
|
0 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Hirsutism
Ext Week 187 n=3
|
2 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Hirsutism
Ext Week 203 n=4
|
2 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Hirsutism
Core Week 1 n=35
|
5 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Hirsutism
Core Week 2 n-33
|
3 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Hirsutism
Core Week 4 n=32
|
4 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Hirsutism
Core Week 8 n=32
|
4 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Hirsutism
Core Week 13 n=27
|
4 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Hirsutism
Core Week 17 n=28
|
3 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Hirsutism
Core Week 22 n=25
|
5 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Hirsutism
Core Week 26 n=27
|
8 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Hirsutism
Core Week 31 n=28
|
9 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Hirsutism
Core Week 35 n=23
|
7 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Hirsutism
Ext Week 43 n=10
|
2 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Hirsutism
Ext Week 59 n=9
|
2 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Hirsutism
Ext Week 75 n=10
|
3 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Hirsutism
Ext Week 91 n=9
|
2 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Hirsutism
Ext Week 107 n=8
|
1 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Hirsutism
Ext Week 123 n=9
|
2 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Hirsutism
Ext Week 139 n=7
|
2 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Hirsutism
Ext Week 155 n=4
|
2 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Hirsutism
Ext Week 171 n=4
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline, weeks 2, 4, every 4 or 5 weeks during core, every 16 weeks during extensionPopulation: Full analysis set. The data beyond Week 139 should be interpreted with caution given that small number of subjects were monitored
Clinical symptoms include: facial rubor, hirsutism, striae, and supraclavicular and dorsal fat pad. Two photographs, one frontal and one lateral from the shoulders up were taken to assess facial plethora, supraclavicular and dorsal fat pads. Two photographs, frontal and dorsal of the trunk with patient in standing position were taken to assess striae, and hirsutism. The photographs were assessed by a qualified physician at the site. Improvement=decrease in severity of symptom since baseline
Outcome measures
| Measure |
All Patients
n=68 Participants
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
|
|---|---|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Striae
Core Week 1 n=40
|
5 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Striae
Core Week 2 n-37
|
2 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Striae
Core Week 4 n=38
|
5 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Striae
Core Week 8 n=37
|
8 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Striae
Core Week 13 n=32
|
7 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Striae
Core Week 17 n=32
|
7 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Striae
Core Week 22 n=28
|
7 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Striae
Core Week 26 n=31
|
9 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Striae
Core Week 31 n=32
|
12 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Striae
Core Week 35 n=26
|
8 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Striae
Ext Week 43 n11=
|
1 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Striae
Ext Week 59 n=11
|
1 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Striae
Ext Week 75 n=12
|
1 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Striae
Ext Week 91 n=10
|
1 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Striae
Ext Week 107 n=9
|
0 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Striae
Ext Week 123 n=10
|
0 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Striae
Ext Week 139 n=7
|
0 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Striae
Ext Week 155 n=4
|
1 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Striae
Ext Week 171 n=3
|
0 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Striae
Ext Week 187 n=3
|
0 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Striae
Ext Week 203 n=4
|
1 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Striae
Ext Week 219 n=2
|
0 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Striae
Ext Week 235 n=3
|
1 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Striae
Ext Week 251 n=1
|
0 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Striae
Ext Week 267 n=1
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline, weeks 2, 4, every 4 or 5 weeks during core, every 8 weeks during extensionPopulation: Full analysis set. The data beyond Week 139 should be interpreted with caution given that small number of subjects were monitored
Clinical symptoms include: facial rubor, hirsutism, striae, and supraclavicular and dorsal fat pad. Two photographs, one frontal and one lateral from the shoulders up were taken to assess facial plethora, supraclavicular and dorsal fat pads. Two photographs, frontal and dorsal of the trunk with patient in standing position were taken to assess striae, and hirsutism. The photographs were assessed by a qualified physician at the site. Improvement=decrease in severity of symptom since baseline
Outcome measures
| Measure |
All Patients
n=68 Participants
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
|
|---|---|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Supraclavicular Fat Pad
Core Week 1 n=40
|
6 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Supraclavicular Fat Pad
Core Week 2 n-37
|
7 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Supraclavicular Fat Pad
Core Week 4 n=37
|
6 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Supraclavicular Fat Pad
Core Week 8 n=37
|
8 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Supraclavicular Fat Pad
Core Week 13 n=32
|
8 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Supraclavicular Fat Pad
Core Week 17 n=32
|
9 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Supraclavicular Fat Pad
Core Week 22 n=28
|
9 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Supraclavicular Fat Pad
Core Week 26 n=31
|
10 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Supraclavicular Fat Pad
Core Week 31 n=32
|
12 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Supraclavicular Fat Pad
Core Week 35 n=26
|
11 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Supraclavicular Fat Pad
Ext Week 43 n=11
|
1 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Supraclavicular Fat Pad
Ext Week 59 n=11
|
0 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Supraclavicular Fat Pad
Ext Week 75 n=12
|
1 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Supraclavicular Fat Pad
Ext Week 91 n=10
|
1 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Supraclavicular Fat Pad
Ext Week 107 n=9
|
0 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Supraclavicular Fat Pad
Ext Week 123 n=10
|
1 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Supraclavicular Fat Pad
Ext Week 139 n=7
|
1 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Supraclavicular Fat Pad
Ext Week 155 n=4
|
1 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Supraclavicular Fat Pad
Ext Week 171 n=3
|
1 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Supraclavicular Fat Pad
Ext Week 187 n=3
|
1 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Supraclavicular Fat Pad
Ext Week 203 n=4
|
1 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Supraclavicular Fat Pad
Ext Week 219 n=2
|
1 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Supraclavicular Fat Pad
Ext Week 235 n=3
|
2 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Supraclavicular Fat Pad
Ext Week 251 n=1
|
0 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Supraclavicular Fat Pad
Ext Week 267 n=1
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, weeks 2, 4, every 4 or 5 weeks during core, every 16 weeks during extensionPopulation: Full analysis set. The data beyond Week 139 should be interpreted with caution given that small number of subjects were monitored
Clinical symptoms include: facial rubor, hirsutism, striae, and supraclavicular and dorsal fat pad. Two photographs, one frontal and one lateral from the shoulders up were taken to assess facial plethora, supraclavicular and dorsal fat pads. Two photographs, frontal and dorsal of the trunk with patient in standing position were taken to assess striae, and hirsutism. The photographs were assessed by a qualified physician at the site. Improvement=decrease in severity of symptom since baseline
Outcome measures
| Measure |
All Patients
n=68 Participants
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
|
|---|---|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Dorsal Fat Pad
Core Week 13 n=32
|
4 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Dorsal Fat Pad
Core Week 17 n=32
|
8 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Dorsal Fat Pad
Core Week 22 n=28
|
8 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Dorsal Fat Pad
Core Week 26 n=31
|
12 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Dorsal Fat Pad
Core Week 31 n=32
|
13 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Dorsal Fat Pad
Core Week 35 n=26
|
9 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Dorsal Fat Pad
Ext Week 43 n=11
|
3 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Dorsal Fat Pad
Ext Week 59 n=10
|
4 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Dorsal Fat Pad
Ext Week 75 n=12
|
5 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Dorsal Fat Pad
Ext Week 91 n=10
|
3 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Dorsal Fat Pad
Core Week 1 n=40
|
6 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Dorsal Fat Pad
Core Week 2 n-37
|
4 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Dorsal Fat Pad
Core Week 4 n=37
|
5 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Dorsal Fat Pad
Core Week 8 n=37
|
5 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Dorsal Fat Pad
Ext Week 155 n=4
|
1 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Dorsal Fat Pad
Ext Week 171 n=3
|
1 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Dorsal Fat Pad
Ext Week 187 n=3
|
2 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Dorsal Fat Pad
Ext Week 203 n=4
|
1 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Dorsal Fat Pad
Ext Week 219 n=2
|
1 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Dorsal Fat Pad
Ext Week 235 n=3
|
2 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Dorsal Fat Pad
Ext Week 251 n=1
|
0 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Dorsal Fat Pad
Ext Week 267 n=1
|
0 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Dorsal Fat Pad
Ext Week 107 n=9
|
2 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Dorsal Fat Pad
Ext Week 123 n=10
|
3 participants
|
|
Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Dorsal Fat Pad
Ext Week 139 n=7
|
3 participants
|
SECONDARY outcome
Timeframe: Baseline, weeks 1, 2, 4, every 4 or 5 weeks during core, every 8 weeks during extensionPopulation: Full analysis set
Facial rubor, hirsutism, striae, and supraclavicular and dorsal fat pad were assessed. Two photographs, one frontal and one lateral from the shoulders up will be taken to assess facial plethora, supraclavicular and dorsal fat pads. Two photographs, frontal and dorsal of the trunk with patient in standing position will be taken to assess striae, and hirsutism. The photographs must be assessed by a qualified physician at the site. Improvement=decrease in severity of symptom since baseline
Outcome measures
| Measure |
All Patients
n=68 Participants
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
|
|---|---|
|
Number of Participants With Shift From Mild to Severe in Clinical Signs of Hypercortisolism
Core Week 35 Facial rubor baseline n=17
|
1 participants
|
|
Number of Participants With Shift From Mild to Severe in Clinical Signs of Hypercortisolism
Ext Week 43 Facial rubor baseline n=17
|
1 participants
|
|
Number of Participants With Shift From Mild to Severe in Clinical Signs of Hypercortisolism
Ext Week 59 Facial rubor baseline n=17
|
1 participants
|
|
Number of Participants With Shift From Mild to Severe in Clinical Signs of Hypercortisolism
Ext Week 67 Facial rubor baseline n=17
|
1 participants
|
|
Number of Participants With Shift From Mild to Severe in Clinical Signs of Hypercortisolism
Ext Week 83 Facial rubor baseline n=17
|
1 participants
|
|
Number of Participants With Shift From Mild to Severe in Clinical Signs of Hypercortisolism
Ext Week 91 Facial rubor baseline n=17
|
1 participants
|
|
Number of Participants With Shift From Mild to Severe in Clinical Signs of Hypercortisolism
Core Week 4 Facial rubor baseline n=17
|
1 participants
|
|
Number of Participants With Shift From Mild to Severe in Clinical Signs of Hypercortisolism
Ext Week 107 Facial rubor baseline n=17
|
1 participants
|
|
Number of Participants With Shift From Mild to Severe in Clinical Signs of Hypercortisolism
Ext Week 99 Facial rubor baseline n=17
|
1 participants
|
|
Number of Participants With Shift From Mild to Severe in Clinical Signs of Hypercortisolism
Ext Week 115 Facial rubor baseline n=17
|
1 participants
|
|
Number of Participants With Shift From Mild to Severe in Clinical Signs of Hypercortisolism
Ext Week 123 Facial rubor baseline n=17
|
1 participants
|
|
Number of Participants With Shift From Mild to Severe in Clinical Signs of Hypercortisolism
Core Week 1 Hirsutism baseline n=12
|
1 participants
|
|
Number of Participants With Shift From Mild to Severe in Clinical Signs of Hypercortisolism
Core Week 2 Hirsutism baseline n=12
|
1 participants
|
|
Number of Participants With Shift From Mild to Severe in Clinical Signs of Hypercortisolism
Ext Week 59 Striae baseline n=10
|
1 participants
|
|
Number of Participants With Shift From Mild to Severe in Clinical Signs of Hypercortisolism
Ext Week 99 Striae baseline n=10
|
1 participants
|
|
Number of Participants With Shift From Mild to Severe in Clinical Signs of Hypercortisolism
Ext Week 107 Striae baseline n=10
|
1 participants
|
|
Number of Participants With Shift From Mild to Severe in Clinical Signs of Hypercortisolism
Ext Week 115 Striae baseline n=10
|
1 participants
|
|
Number of Participants With Shift From Mild to Severe in Clinical Signs of Hypercortisolism
Ext Week 123 Striae baseline n=10
|
1 participants
|
|
Number of Participants With Shift From Mild to Severe in Clinical Signs of Hypercortisolism
Ext Week 99 Supraclavicular fat pad BL n=17
|
1 participants
|
|
Number of Participants With Shift From Mild to Severe in Clinical Signs of Hypercortisolism
Ext Week 107 Supraclavicular fat pad BL n=17
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline up to week 267Population: Full analysis set
To test proximal muscle strength patients should be placed in a low seated position (for instance on an examination room stool). They should be asked to extend the arms in front of them. From this seated position patients will be asked to stand up. Patients will be evaluated using the following scale: 3. - completely unable to stand 2. - able to stand only by using arms as assistance 1\. - able to stand after several efforts without using arms as assistance 0. - able to stand easily with arms extended
Outcome measures
| Measure |
All Patients
n=68 Participants
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
|
|---|---|
|
Number of Patients With Shift From Standing Easily to Not Being Able to Stand
Core Week 26
|
1 participants
|
|
Number of Patients With Shift From Standing Easily to Not Being Able to Stand
Core Week 35
|
1 participants
|
Adverse Events
All Patients
Serious events: 15 serious events
Other events: 67 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
All Patients
n=68 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Cardiac disorders
Coronary artery disease
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Endocrine disorders
Glucocorticoid deficiency
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
2/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
General disorders
Death
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
General disorders
Multiple organ dysfunction syndrome
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Hepatobiliary disorders
Bile duct stone
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Hepatobiliary disorders
Cholecystitis
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.9%
2/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Infections and infestations
Abscess limb
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Infections and infestations
Cellulitis
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Infections and infestations
Varicella
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Injury, poisoning and procedural complications
Radius fracture
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Injury, poisoning and procedural complications
Wound
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Investigations
Alanine aminotransferase increased
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Investigations
Aspartate aminotransferase increased
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Nervous system disorders
Headache
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Nervous system disorders
Presyncope
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Nervous system disorders
Syncope
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Renal and urinary disorders
Renal failure
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Vascular disorders
Hypertension
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Vascular disorders
Shock haemorrhagic
|
1.5%
1/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
Other adverse events
| Measure |
All Patients
n=68 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.8%
6/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Cardiac disorders
Bradycardia
|
5.9%
4/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Cardiac disorders
Mitral valve incompetence
|
7.4%
5/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
16.2%
11/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.8%
6/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Gastrointestinal disorders
Diarrhoea
|
44.1%
30/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Gastrointestinal disorders
Flatulence
|
5.9%
4/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Gastrointestinal disorders
Nausea
|
51.5%
35/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
4/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
General disorders
Asthenia
|
10.3%
7/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
General disorders
Fatigue
|
19.1%
13/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
General disorders
Oedema peripheral
|
8.8%
6/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
General disorders
Pyrexia
|
5.9%
4/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Hepatobiliary disorders
Cholelithiasis
|
32.4%
22/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Hepatobiliary disorders
Hepatic steatosis
|
5.9%
4/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Infections and infestations
Influenza
|
5.9%
4/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Infections and infestations
Nasopharyngitis
|
16.2%
11/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Infections and infestations
Urinary tract infection
|
8.8%
6/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Investigations
Alanine aminotransferase increased
|
7.4%
5/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Investigations
Gamma-glutamyltransferase increased
|
16.2%
11/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.8%
6/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
17.6%
12/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
5.9%
4/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
7.4%
5/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
51.5%
35/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
7.4%
5/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
7.4%
5/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
16.2%
11/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
5.9%
4/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
8.8%
6/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
19.1%
13/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.9%
4/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.8%
6/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.8%
6/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.2%
9/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Nervous system disorders
Dizziness
|
27.9%
19/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Nervous system disorders
Headache
|
29.4%
20/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Nervous system disorders
Somnolence
|
5.9%
4/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Nervous system disorders
Tremor
|
5.9%
4/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Psychiatric disorders
Depression
|
11.8%
8/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Psychiatric disorders
Insomnia
|
10.3%
7/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.7%
10/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.2%
9/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.8%
8/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
|
Vascular disorders
Hypertension
|
7.4%
5/68 • Adverse events were collected from first dose of study treatment until end of study treatment plus 28 days post treatment, up to maximum duration of 272 weeks
Any sign or symptom that occurs during the study treatment plus 28 days post treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER