Trial Outcomes & Findings for The "VISION" Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial Hypertension (NCT NCT00302211)
NCT ID: NCT00302211
Last Updated: 2025-02-04
Results Overview
The 6MWD test is a non-encouraged test, performed in a 30-meter long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones during 6 minutes. They can slow down, rest, or stop if needed. This test is used to assess exercise capacity. The test was performed about 30 minutes after study drug administration. Any increase in the walk distance was considered improvement from baseline.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
67 participants
Primary outcome timeframe
Day 1 and Week 16
Results posted on
2025-02-04
Participant Flow
Due to slow participant enrollment, the study was prematurely terminated, and recruitment was stopped after 67 subjects had been recruited instead of 180 initially planned (37% of the originally-planned sample size)
Participant milestones
| Measure |
DB Iloprost 6×/Day
Inhaled iloprost (5 μg) 6×/day plus sildenafil with or without bosentan
|
DB Iloprost 4×/Day
Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan
|
DB Placebo 6×/Day
Inhaled placebo 6×/day plus sildenafil with or without bosentan
|
OL Iloprost 6x/Day
The subjects received inhaled iloprost(5 μg) 6 times per day plus sildenafil with or without bosentan during the 32-week open-label period
|
OL Inhaled Iloprost 4x/Day
Subjects in this group received inhaled iloprost (5μg) 4x/day plus sildenafil with or without bosentan during the open-label period
|
|---|---|---|---|---|---|
|
Double Blind Period (New Patients)
STARTED
|
26
|
27
|
14
|
0
|
0
|
|
Double Blind Period (New Patients)
COMPLETED
|
23
|
25
|
10
|
0
|
0
|
|
Double Blind Period (New Patients)
NOT COMPLETED
|
3
|
2
|
4
|
0
|
0
|
|
Open Label-Patients From Double-Blind
STARTED
|
0
|
0
|
0
|
26
|
32
|
|
Open Label-Patients From Double-Blind
COMPLETED
|
0
|
0
|
0
|
18
|
24
|
|
Open Label-Patients From Double-Blind
NOT COMPLETED
|
0
|
0
|
0
|
8
|
8
|
Reasons for withdrawal
| Measure |
DB Iloprost 6×/Day
Inhaled iloprost (5 μg) 6×/day plus sildenafil with or without bosentan
|
DB Iloprost 4×/Day
Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan
|
DB Placebo 6×/Day
Inhaled placebo 6×/day plus sildenafil with or without bosentan
|
OL Iloprost 6x/Day
The subjects received inhaled iloprost(5 μg) 6 times per day plus sildenafil with or without bosentan during the 32-week open-label period
|
OL Inhaled Iloprost 4x/Day
Subjects in this group received inhaled iloprost (5μg) 4x/day plus sildenafil with or without bosentan during the open-label period
|
|---|---|---|---|---|---|
|
Double Blind Period (New Patients)
Withdrawal by Subject
|
2
|
1
|
0
|
0
|
0
|
|
Double Blind Period (New Patients)
Adverse Event
|
0
|
0
|
3
|
0
|
0
|
|
Double Blind Period (New Patients)
Investigator's judgement
|
1
|
0
|
0
|
0
|
0
|
|
Double Blind Period (New Patients)
Disease progression
|
0
|
1
|
1
|
0
|
0
|
|
Open Label-Patients From Double-Blind
Withdrawal by Subject
|
0
|
0
|
0
|
3
|
3
|
|
Open Label-Patients From Double-Blind
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
|
Open Label-Patients From Double-Blind
Investigator's judgement
|
0
|
0
|
0
|
1
|
0
|
|
Open Label-Patients From Double-Blind
Disease progression
|
0
|
0
|
0
|
1
|
2
|
|
Open Label-Patients From Double-Blind
Death
|
0
|
0
|
0
|
1
|
1
|
|
Open Label-Patients From Double-Blind
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
|
Open Label-Patients From Double-Blind
PH requiring lung transplant
|
0
|
0
|
0
|
0
|
1
|
|
Open Label-Patients From Double-Blind
Termination of the study by the sponsor
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
The "VISION" Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial Hypertension
Baseline characteristics by cohort
| Measure |
DB Iloprost 6×/Day
n=26 Participants
Inhaled iloprost (5 μg) 6×/day plus sildenafil with or without bosentan
|
DB Iloprost 4×/Day
n=27 Participants
Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan
|
DB Placebo 6×/Day
n=14 Participants
Inhaled placebo 6×/day plus sildenafil with or without bosentan
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Age, Continuous
|
51.9 years
STANDARD_DEVIATION 11.95 • n=5 Participants
|
56.6 years
STANDARD_DEVIATION 16.27 • n=7 Participants
|
56.9 years
STANDARD_DEVIATION 11.90 • n=5 Participants
|
54.8 years
STANDARD_DEVIATION 13.85 • n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Region of Enrollment
Austria
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Week 16Population: Only Participants in the double-blind treatment period were included if they received at least one dose of study drug and had at least one post-baseline efficacy measure at Week 16. Due to early study termination (about 30% of the enrollment goal) the study was severely under-powered and no accurate statistical analyses could be performed.
The 6MWD test is a non-encouraged test, performed in a 30-meter long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones during 6 minutes. They can slow down, rest, or stop if needed. This test is used to assess exercise capacity. The test was performed about 30 minutes after study drug administration. Any increase in the walk distance was considered improvement from baseline.
Outcome measures
| Measure |
DB Iloprost 6×/Day
n=26 Participants
Inhaled iloprost (5 μg) 6×/day plus sildenafil with or without bosentan
|
DB Iloprost 4×/Day
n=27 Participants
Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan
|
DB Placebo 6×/Day
n=13 Participants
Inhaled placebo 6×/day plus sildenafil with or without bosentan
|
OL Iloprost 6x/Day
The subjects received inhaled iloprost(5 μg) 6 times per day plus sildenafil with or without bosentan during the 32-week open-label period
|
OL Iloprost 4x/Day
The subjects received inhaled iloprost (5μg) 4 times per day plus sildenafil with or without bosentan during the 32-week open-label period
|
|---|---|---|---|---|---|
|
Absolute Change From Baseline to Week 16 in 6-Minute Walk Distance (6MWD) During the Double-blind Treatment Period
|
10.1 Meters
Standard Deviation 62.15
|
29.6 Meters
Standard Deviation 55.17
|
-22.0 Meters
Standard Deviation 124.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Week 16Population: Only Participants in the double-blind treatment period were included if they received at least one dose of study drug and had at least one post-baseline efficacy measure at Week 16. Due to early study termination (about 30% of the enrollment goal) the study was severely under-powered and no accurate statistical analyses could be performed.
This test is used to assess disease severity. Four fucntional classes (FC) are defined from FC I (no limitation of physical activity) to FC IV (inability to carry out any physical activity without symptoms). Improvement is considered when a participant changes from a higher class to a lower class.
Outcome measures
| Measure |
DB Iloprost 6×/Day
n=26 Participants
Inhaled iloprost (5 μg) 6×/day plus sildenafil with or without bosentan
|
DB Iloprost 4×/Day
n=27 Participants
Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan
|
DB Placebo 6×/Day
n=13 Participants
Inhaled placebo 6×/day plus sildenafil with or without bosentan
|
OL Iloprost 6x/Day
The subjects received inhaled iloprost(5 μg) 6 times per day plus sildenafil with or without bosentan during the 32-week open-label period
|
OL Iloprost 4x/Day
The subjects received inhaled iloprost (5μg) 4 times per day plus sildenafil with or without bosentan during the 32-week open-label period
|
|---|---|---|---|---|---|
|
Number of Subjects With WHO Functional Class (WHO FC) Improvement at Week 16
|
4 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 16 and Week 48Population: Only participants who received at least one dose of study drug and with available data at Week 16 (for the double-blind period) and at Week 48 (for the open-label period) were included in the analysis
Clinical worsening is defined as one of the following: death due to worsening PAH, receipt of lung or heart-lung transplantation, or atrial septostomy, hospitalization for worsening PAH, any early discontinuation from study during the blinded or open-label phase due to worsening PAH, initiation of additional PAH-specific treatment. Due to insufficient data, time could not be assessed accurately and only number of patients with clinical worsening could be reported.
Outcome measures
| Measure |
DB Iloprost 6×/Day
n=26 Participants
Inhaled iloprost (5 μg) 6×/day plus sildenafil with or without bosentan
|
DB Iloprost 4×/Day
n=27 Participants
Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan
|
DB Placebo 6×/Day
n=14 Participants
Inhaled placebo 6×/day plus sildenafil with or without bosentan
|
OL Iloprost 6x/Day
n=22 Participants
The subjects received inhaled iloprost(5 μg) 6 times per day plus sildenafil with or without bosentan during the 32-week open-label period
|
OL Iloprost 4x/Day
n=28 Participants
The subjects received inhaled iloprost (5μg) 4 times per day plus sildenafil with or without bosentan during the 32-week open-label period
|
|---|---|---|---|---|---|
|
Time to Clinical Worsening
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Day 1 to Week 16 and Week 48Population: Safety population: All randomiized subjects who received at least one dose of the study drug
This is the overall number of participants in each group who reported at least one adverse event (i.e., any untoward medical occurrence or unfavorable and unintended sign whether or not considered related to the study drug) with an onset from the first administration of study drug up to the last study visit.
Outcome measures
| Measure |
DB Iloprost 6×/Day
n=26 Participants
Inhaled iloprost (5 μg) 6×/day plus sildenafil with or without bosentan
|
DB Iloprost 4×/Day
n=27 Participants
Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan
|
DB Placebo 6×/Day
n=14 Participants
Inhaled placebo 6×/day plus sildenafil with or without bosentan
|
OL Iloprost 6x/Day
n=26 Participants
The subjects received inhaled iloprost(5 μg) 6 times per day plus sildenafil with or without bosentan during the 32-week open-label period
|
OL Iloprost 4x/Day
n=32 Participants
The subjects received inhaled iloprost (5μg) 4 times per day plus sildenafil with or without bosentan during the 32-week open-label period
|
|---|---|---|---|---|---|
|
Number of Participants With Any Adverse Events
|
24 Participants
|
22 Participants
|
14 Participants
|
23 Participants
|
30 Participants
|
POST_HOC outcome
Timeframe: Week 16Population: Only Participants in the double-blind treatment period were included if they received at least one dose of study drug and had a post-baseline efficacy measure at Week 16.
The number of participants in the double-blind treatment period who showed improvement or worsening in the 6-MWT - from baseline distance between 100-450 meters - was assessed for each treatment group. The 6-minute walks were measured in meters. Any increase in walk distance at Week 16 was considered improvement from baseline, any decrease was considered as deterioration from baseline.
Outcome measures
| Measure |
DB Iloprost 6×/Day
n=26 Participants
Inhaled iloprost (5 μg) 6×/day plus sildenafil with or without bosentan
|
DB Iloprost 4×/Day
n=27 Participants
Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan
|
DB Placebo 6×/Day
n=13 Participants
Inhaled placebo 6×/day plus sildenafil with or without bosentan
|
OL Iloprost 6x/Day
The subjects received inhaled iloprost(5 μg) 6 times per day plus sildenafil with or without bosentan during the 32-week open-label period
|
OL Iloprost 4x/Day
The subjects received inhaled iloprost (5μg) 4 times per day plus sildenafil with or without bosentan during the 32-week open-label period
|
|---|---|---|---|---|---|
|
Number of Participants With Change From Baseline to Week 16 in 6-Minute Walk Test (MWT) During the Double-blind Period
6-MWT deterioration
|
12 Participants
|
8 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants With Change From Baseline to Week 16 in 6-Minute Walk Test (MWT) During the Double-blind Period
No change
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Change From Baseline to Week 16 in 6-Minute Walk Test (MWT) During the Double-blind Period
6-MWT improvement
|
13 Participants
|
18 Participants
|
9 Participants
|
—
|
—
|
Adverse Events
DB Iloprost 6×/Day
Serious events: 3 serious events
Other events: 24 other events
Deaths: 0 deaths
DB Iloprost 4×/Day
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
DB Placebo 6×/Day
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
OL Iloprost 6x/Day
Serious events: 4 serious events
Other events: 23 other events
Deaths: 0 deaths
OL Iloprost 4x/Day
Serious events: 13 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DB Iloprost 6×/Day
n=26 participants at risk
Inhaled iloprost (5 μg) 6×/day plus sildenafil with or without bosentan
|
DB Iloprost 4×/Day
n=27 participants at risk
Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan
|
DB Placebo 6×/Day
n=14 participants at risk
Inhaled placebo 6×/day plus sildenafil with or without bosentan
|
OL Iloprost 6x/Day
n=26 participants at risk
The subjects received inhaled iloprost(5 μg) 6 times per day plus sildenafil with or without bosentan during the 32-week open-label period
|
OL Iloprost 4x/Day
n=32 participants at risk
The subjects received inhaled iloprost (5μg) 4 times per day plus sildenafil with or without bosentan during the 32-week open-label period
|
|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Cardiac disorders
Right ventricular failure
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.1%
1/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
General disorders
Chest pain
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.1%
1/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Infections and infestations
Gastroenteritis viral
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.1%
1/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Metabolism and nutrition disorders
Fluid overload
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
6.2%
2/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.1%
1/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
14.3%
2/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
9.4%
3/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.1%
1/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.1%
1/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.1%
1/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.1%
1/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.1%
1/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Nervous system disorders
Syncope
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.1%
1/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Vascular disorders
Lupus vasculitis
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
Other adverse events
| Measure |
DB Iloprost 6×/Day
n=26 participants at risk
Inhaled iloprost (5 μg) 6×/day plus sildenafil with or without bosentan
|
DB Iloprost 4×/Day
n=27 participants at risk
Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan
|
DB Placebo 6×/Day
n=14 participants at risk
Inhaled placebo 6×/day plus sildenafil with or without bosentan
|
OL Iloprost 6x/Day
n=26 participants at risk
The subjects received inhaled iloprost(5 μg) 6 times per day plus sildenafil with or without bosentan during the 32-week open-label period
|
OL Iloprost 4x/Day
n=32 participants at risk
The subjects received inhaled iloprost (5μg) 4 times per day plus sildenafil with or without bosentan during the 32-week open-label period
|
|---|---|---|---|---|---|
|
Cardiac disorders
Arrhythmia
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Cardiac disorders
Atrial flutter
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.1%
1/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Cardiac disorders
Palpitations
|
11.5%
3/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.7%
2/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Cardiac disorders
Right ventricular failure
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Cardiac disorders
Tachycardia
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.1%
1/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Cardiac disorders
Ventricular arrhythmia
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Cardiac disorders
Ventricular extrasystoles
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Ear and labyrinth disorders
Ear pain
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.1%
1/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
2/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.1%
1/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
6.2%
2/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Gastrointestinal disorders
Dry mouth
|
7.7%
2/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
11.5%
3/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.1%
1/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Gastrointestinal disorders
Dysphagia
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Gastrointestinal disorders
Glossodynia
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Gastrointestinal disorders
Mouth ulceration
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
2/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.4%
2/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.1%
1/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Gastrointestinal disorders
Oesophagitis
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.1%
1/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
General disorders
Asthenia
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
General disorders
Chest discomfort
|
15.4%
4/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.1%
1/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.7%
2/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.1%
1/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
General disorders
Chest pain
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.1%
1/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
General disorders
Chills
|
7.7%
2/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
General disorders
Fatigue
|
7.7%
2/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.1%
1/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.1%
1/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
General disorders
Oedema
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
General disorders
Oedema peripheral
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
11.1%
3/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.1%
1/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.4%
2/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.1%
1/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Infections and infestations
Gastroenteritis viral
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Infections and infestations
Infection
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Infections and infestations
Influenza
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Infections and infestations
Lymph gland infection
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Infections and infestations
Mastitis
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Infections and infestations
Nasopharyngitis
|
15.4%
4/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.4%
2/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.1%
1/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.1%
1/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Infections and infestations
Oral herpes
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Infections and infestations
Pharyngitis
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.1%
1/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Infections and infestations
Rash pustular
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Infections and infestations
Rhinitis
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Infections and infestations
Sinusitis
|
11.5%
3/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Infections and infestations
Tooth abscess
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
2/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.1%
1/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Infections and infestations
Viral infection
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.1%
1/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Injury, poisoning and procedural complications
Head injury
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.1%
1/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Metabolism and nutrition disorders
Fluid overload
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.1%
1/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.1%
1/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.5%
3/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.1%
1/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.1%
1/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.1%
1/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.1%
1/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
7.7%
2/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal sinus cancer
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.1%
1/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Nervous system disorders
Dizziness
|
15.4%
4/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
21.4%
3/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
19.2%
5/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.1%
1/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Nervous system disorders
Headache
|
38.5%
10/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
25.9%
7/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
14.3%
2/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
38.5%
10/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
18.8%
6/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.1%
1/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Nervous system disorders
Presyncope
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.4%
2/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Nervous system disorders
Somnolence
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Nervous system disorders
Syncope
|
7.7%
2/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
11.1%
3/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.1%
1/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Psychiatric disorders
Anxiety
|
7.7%
2/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Psychiatric disorders
Dyssomnia
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Psychiatric disorders
Nervousness
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Psychiatric disorders
Dysuria
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Reproductive system and breast disorders
Penile oedema
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.1%
6/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
29.6%
8/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
14.3%
2/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
15.4%
4/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
6.2%
2/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
11.5%
3/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.7%
2/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
7.7%
2/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.7%
2/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.1%
1/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.7%
2/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.4%
2/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.7%
2/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.1%
1/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.1%
1/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
15.4%
4/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.1%
1/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
21.4%
3/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
15.4%
4/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.1%
1/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.1%
1/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.1%
1/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.1%
1/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.4%
2/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.1%
1/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Surgical and medical procedures
Inguinal hernia
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.7%
1/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Surgical and medical procedures
Medical device implantation
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Vascular disorders
Cardiovascular insufficiency
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Vascular disorders
Flushing
|
23.1%
6/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
11.1%
3/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.1%
1/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
23.1%
6/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
12.5%
4/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Vascular disorders
Hypotension
|
11.5%
3/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
14.8%
4/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
7.1%
1/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
6.2%
2/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.1%
1/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.1%
1/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.1%
1/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
Infections and infestations
Ear infection
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
3.1%
1/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
|
General disorders
Swelling
|
3.8%
1/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/27 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/14 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/26 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
|
0.00%
0/32 • from Day 1 (Baseline) up to Week 48 (or up to 30 days after the last dose of study drug for serious adverse events)
Safety was assessed on the basis of adverse events, laboratory tests, physical examination and vital signs during both the double-blind and open-label phases of the study.
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Additional Information
Gary Palmer SVP, US Medical Affairs
Actelion Pharmaceuticals US, Inc.
Phone: 650-624-6900
Results disclosure agreements
- Principal investigator is a sponsor employee Written permission to publish results must be obtained in advance from Actelion (formerly CoTherix). Manuscript of any proposed publication must be sent to Actelion at least 30 days in advance of the submission date. Actelion will inform in writing of any objection of specific content in the proposed publication.In addition, the institution shall either delete disclosure of all potentially patentable inventions or delay submission of the proposed publication for up to 90 days.
- Publication restrictions are in place
Restriction type: OTHER