Trial Outcomes & Findings for OpiCapone Effect on Motor Fluctuations and pAiN (NCT NCT04986982)
NCT ID: NCT04986982
Last Updated: 2025-03-28
Results Overview
The KING's PARKINSON's DISEASE PAIN SCALE (KPPS) evaluates the burden (global and bedside) and characterises various phenotypes of pain in Parkinson's disease. The investigator will complete the questionnaire by interviewing the patient about seven domains and answering to 14 items. The questionnaire will be fill out on Visit 1, Visit 2b/Baseline, Visit 4, Visit 5 and Visit 6/EDV Domain 3 assesses fluctuation-related pain (score range: 0 - 36). Higher score values indicate higher levels of pain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
144 participants
Primary outcome timeframe
The questionnaire will be fill out on Visit 1 (Day -7 ±2), Visit 2b/Baseline (Day 1), Visit 4 (Day 29 (±2)), Visit 5 (Day 85 (±4)) and Visit 6/Early Discontinuation Visit (EDV) (Day 169 (±4)) - Up to 24 weeks
Results posted on
2025-03-28
Participant Flow
A total of 144 patients were enrolled and 19 patients prematurely terminated the trial.
Participant milestones
| Measure |
Opicapone 50 mg
Opicapone (BIA 9-1067)
Opicapone 50 mg: Opicapone (BIA 9-1067) 50 mg hard capsules. Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI
|
Placebo
Placebo
Placebo: Matching placebo hard capsules. Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
63
|
|
Overall Study
Safety Set
|
64
|
63
|
|
Overall Study
Full Analysis Set
|
59
|
63
|
|
Overall Study
COMPLETED
|
53
|
55
|
|
Overall Study
NOT COMPLETED
|
11
|
8
|
Reasons for withdrawal
| Measure |
Opicapone 50 mg
Opicapone (BIA 9-1067)
Opicapone 50 mg: Opicapone (BIA 9-1067) 50 mg hard capsules. Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI
|
Placebo
Placebo
Placebo: Matching placebo hard capsules. Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
2
|
|
Overall Study
Ineligibility
|
3
|
0
|
|
Overall Study
Adverse Event
|
4
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Sponsor's discretion
|
1
|
0
|
Baseline Characteristics
For childbearing potential, the percentage is based on the number of females.
Baseline characteristics by cohort
| Measure |
Opicapone 50 mg
n=59 Participants
Opicapone (BIA 9-1067)
Opicapone 50 mg: Opicapone (BIA 9-1067) 50 mg hard capsules. Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI
|
Placebo
n=63 Participants
Placebo
Placebo: Matching placebo hard capsules. Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.9 years
STANDARD_DEVIATION 9.14 • n=59 Participants
|
65.5 years
STANDARD_DEVIATION 9.39 • n=63 Participants
|
66.2 years
STANDARD_DEVIATION 9.26 • n=122 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=59 Participants
|
31 Participants
n=63 Participants
|
58 Participants
n=122 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=59 Participants
|
32 Participants
n=63 Participants
|
64 Participants
n=122 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=59 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=122 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=59 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=122 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=59 Participants
|
1 Participants
n=63 Participants
|
1 Participants
n=122 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=59 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=122 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=59 Participants
|
62 Participants
n=63 Participants
|
121 Participants
n=122 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=59 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=122 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=59 Participants
|
0 Participants
n=63 Participants
|
0 Participants
n=122 Participants
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=59 Participants
|
11 participants
n=63 Participants
|
17 participants
n=122 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=59 Participants
|
5 participants
n=63 Participants
|
7 participants
n=122 Participants
|
|
Region of Enrollment
Poland
|
14 participants
n=59 Participants
|
14 participants
n=63 Participants
|
28 participants
n=122 Participants
|
|
Region of Enrollment
Italy
|
9 participants
n=59 Participants
|
1 participants
n=63 Participants
|
10 participants
n=122 Participants
|
|
Region of Enrollment
Portugal
|
7 participants
n=59 Participants
|
11 participants
n=63 Participants
|
18 participants
n=122 Participants
|
|
Region of Enrollment
Czechia
|
16 participants
n=59 Participants
|
10 participants
n=63 Participants
|
26 participants
n=122 Participants
|
|
Region of Enrollment
Spain
|
5 participants
n=59 Participants
|
11 participants
n=63 Participants
|
16 participants
n=122 Participants
|
|
Age, Categorical
≥ 18 years - < 65 years
|
21 Participants
n=59 Participants
|
29 Participants
n=63 Participants
|
50 Participants
n=122 Participants
|
|
Age, Categorical
≥ 65 years - < 85 years
|
37 Participants
n=59 Participants
|
34 Participants
n=63 Participants
|
71 Participants
n=122 Participants
|
|
Age, Categorical
≥ 85 years
|
1 Participants
n=59 Participants
|
0 Participants
n=63 Participants
|
1 Participants
n=122 Participants
|
|
Childbearing potential
Yes
|
1 Participants
n=27 Participants • For childbearing potential, the percentage is based on the number of females.
|
2 Participants
n=31 Participants • For childbearing potential, the percentage is based on the number of females.
|
3 Participants
n=58 Participants • For childbearing potential, the percentage is based on the number of females.
|
|
Childbearing potential
No
|
26 Participants
n=27 Participants • For childbearing potential, the percentage is based on the number of females.
|
29 Participants
n=31 Participants • For childbearing potential, the percentage is based on the number of females.
|
55 Participants
n=58 Participants • For childbearing potential, the percentage is based on the number of females.
|
|
Body mass index (BMI)
|
28.16 kg/m^2
STANDARD_DEVIATION 4.934 • n=59 Participants
|
29.10 kg/m^2
STANDARD_DEVIATION 5.079 • n=63 Participants
|
28.65 kg/m^2
STANDARD_DEVIATION 5.011 • n=122 Participants
|
PRIMARY outcome
Timeframe: The questionnaire will be fill out on Visit 1 (Day -7 ±2), Visit 2b/Baseline (Day 1), Visit 4 (Day 29 (±2)), Visit 5 (Day 85 (±4)) and Visit 6/Early Discontinuation Visit (EDV) (Day 169 (±4)) - Up to 24 weeksPopulation: A total of 122 (96.1%) patients met the criteria for the full analysis set (FAS) including 59 (92.2%) opicapone 50 mg and 63 (100.0%) placebo patients.
The KING's PARKINSON's DISEASE PAIN SCALE (KPPS) evaluates the burden (global and bedside) and characterises various phenotypes of pain in Parkinson's disease. The investigator will complete the questionnaire by interviewing the patient about seven domains and answering to 14 items. The questionnaire will be fill out on Visit 1, Visit 2b/Baseline, Visit 4, Visit 5 and Visit 6/EDV Domain 3 assesses fluctuation-related pain (score range: 0 - 36). Higher score values indicate higher levels of pain.
Outcome measures
| Measure |
Opicapone 50 mg
n=59 Participants
Opicapone (BIA 9-1067)
Opicapone 50 mg: Opicapone (BIA 9-1067) 50 mg hard capsules. Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI
|
Placebo
n=63 Participants
Placebo
Placebo: Matching placebo hard capsules. Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI
|
|---|---|---|
|
Change From Baseline in Domain 3 (Fluctuation-related Pain) of KING's PARKINSON's DISEASE PAIN SCALE (KPPS)
Visit 1 (Day -7 ±2)
|
17.2 score on a scale
Standard Deviation 5.72
|
16.7 score on a scale
Standard Deviation 5.18
|
|
Change From Baseline in Domain 3 (Fluctuation-related Pain) of KING's PARKINSON's DISEASE PAIN SCALE (KPPS)
Visit 2b (Day 1)
|
17.1 score on a scale
Standard Deviation 5.58
|
16.9 score on a scale
Standard Deviation 5.20
|
|
Change From Baseline in Domain 3 (Fluctuation-related Pain) of KING's PARKINSON's DISEASE PAIN SCALE (KPPS)
Baseline (Day 1)
|
17.1 score on a scale
Standard Deviation 5.58
|
16.9 score on a scale
Standard Deviation 5.20
|
|
Change From Baseline in Domain 3 (Fluctuation-related Pain) of KING's PARKINSON's DISEASE PAIN SCALE (KPPS)
Visit 4 (Day 29 (±2)) - Observed Value
|
10.5 score on a scale
Standard Deviation 7.92
|
11.0 score on a scale
Standard Deviation 7.51
|
|
Change From Baseline in Domain 3 (Fluctuation-related Pain) of KING's PARKINSON's DISEASE PAIN SCALE (KPPS)
Visit 4 (Day 29 (±2)) - Change from Baseline
|
-6.6 score on a scale
Standard Deviation 7.28
|
-5.9 score on a scale
Standard Deviation 6.02
|
|
Change From Baseline in Domain 3 (Fluctuation-related Pain) of KING's PARKINSON's DISEASE PAIN SCALE (KPPS)
Visit 5 (Day 85 (±4)) - Observed Value
|
8.3 score on a scale
Standard Deviation 7.27
|
9.3 score on a scale
Standard Deviation 5.73
|
|
Change From Baseline in Domain 3 (Fluctuation-related Pain) of KING's PARKINSON's DISEASE PAIN SCALE (KPPS)
Visit 5 (Day 85 (±4)) - Change from Baseline
|
-8.7 score on a scale
Standard Deviation 6.68
|
-7.6 score on a scale
Standard Deviation 6.13
|
|
Change From Baseline in Domain 3 (Fluctuation-related Pain) of KING's PARKINSON's DISEASE PAIN SCALE (KPPS)
Visit 6 (Day 169 (±4)) - Observed Value
|
8.4 score on a scale
Standard Deviation 6.93
|
7.5 score on a scale
Standard Deviation 6.48
|
|
Change From Baseline in Domain 3 (Fluctuation-related Pain) of KING's PARKINSON's DISEASE PAIN SCALE (KPPS)
Visit 6 (Day 169 (±4)) - Change from Baseline
|
-8.8 score on a scale
Standard Deviation 6.85
|
-9.3 score on a scale
Standard Deviation 6.24
|
Adverse Events
Opicapone 50 mg
Serious events: 4 serious events
Other events: 40 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Opicapone 50 mg
n=64 participants at risk
Opicapone (BIA 9-1067)
Opicapone 50 mg: Opicapone (BIA 9-1067) 50 mg hard capsules. Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI
|
Placebo
n=63 participants at risk
Placebo
Placebo: Matching placebo hard capsules. Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Infections and infestations
Sepsis
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Infections and infestations
Skin infection
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
1/64 • Number of events 2 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Gastrointestinal disorders
Faecaloma
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Injury, poisoning and procedural complications
Fall
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
Other adverse events
| Measure |
Opicapone 50 mg
n=64 participants at risk
Opicapone (BIA 9-1067)
Opicapone 50 mg: Opicapone (BIA 9-1067) 50 mg hard capsules. Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI
|
Placebo
n=63 participants at risk
Placebo
Placebo: Matching placebo hard capsules. Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI
|
|---|---|---|
|
Injury, poisoning and procedural complications
Skin abrasion
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Injury, poisoning and procedural complications
Chest injury
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Nervous system disorders
Dyskinesia
|
4.7%
3/64 • Number of events 3 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
6.3%
4/63 • Number of events 4 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Nervous system disorders
Headache
|
4.7%
3/64 • Number of events 4 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
4.8%
3/63 • Number of events 3 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Nervous system disorders
Parkinson's disease
|
4.7%
3/64 • Number of events 3 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
4.8%
3/63 • Number of events 3 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Nervous system disorders
Dizziness
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
4.8%
3/63 • Number of events 4 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Nervous system disorders
On and off phenomenon
|
3.1%
2/64 • Number of events 2 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
3.2%
2/63 • Number of events 2 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Nervous system disorders
Sciatica
|
3.1%
2/64 • Number of events 2 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Nervous system disorders
Altered state of consciousness
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Nervous system disorders
Balance disorder
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Nervous system disorders
Bradykinesia
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Nervous system disorders
Dystonia
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Nervous system disorders
Freezing phenomenon
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Nervous system disorders
Hemiparesis
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Nervous system disorders
Hypoaesthesia
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Nervous system disorders
Memory impairment
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Nervous system disorders
Poor quality sleep
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Nervous system disorders
Somnolence
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Nervous system disorders
Taste disorder
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Nervous system disorders
Tremor
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Gastrointestinal disorders
Nausea
|
10.9%
7/64 • Number of events 8 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
7.9%
5/63 • Number of events 5 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Gastrointestinal disorders
Constipation
|
7.8%
5/64 • Number of events 5 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.1%
2/64 • Number of events 2 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Gastrointestinal disorders
Dry mouth
|
3.1%
2/64 • Number of events 2 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
3.2%
2/63 • Number of events 2 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Gastrointestinal disorders
Gastritis
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Gastrointestinal disorders
Oral discomfort
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Gastrointestinal disorders
Toothache
|
1.6%
1/64 • Number of events 3 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Gastrointestinal disorders
Umbilical hernia
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Psychiatric disorders
Anxiety
|
9.4%
6/64 • Number of events 6 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
3.2%
2/63 • Number of events 3 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Psychiatric disorders
Insomnia
|
4.7%
3/64 • Number of events 3 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
4.8%
3/63 • Number of events 3 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Psychiatric disorders
Depression
|
4.7%
3/64 • Number of events 3 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Psychiatric disorders
Hallucination, visual
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Psychiatric disorders
Abnormal dreams
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Psychiatric disorders
Bruxism
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Psychiatric disorders
Delirium
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Psychiatric disorders
Delusion
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Psychiatric disorders
Depressed mood
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Psychiatric disorders
Hallucinations, mixed
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Psychiatric disorders
Illusion
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Psychiatric disorders
Impulse-control disorder
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Psychiatric disorders
Irritability
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Psychiatric disorders
Mixed anxiety and depressive disorder
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Psychiatric disorders
Mood altered
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Psychiatric disorders
Nightmare
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Psychiatric disorders
Obsessive-compulsive disorder
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Psychiatric disorders
Sleep disorder
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Psychiatric disorders
Terminal insomnia
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
General disorders
Pain
|
7.8%
5/64 • Number of events 6 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
4.8%
3/63 • Number of events 3 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
General disorders
Fatigue
|
3.1%
2/64 • Number of events 2 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
3.2%
2/63 • Number of events 2 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
General disorders
Oedema peripheral
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
General disorders
Application site irritation
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
General disorders
Asthenia
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
General disorders
Malaise
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Infections and infestations
Bronchitis
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Infections and infestations
COVID-19
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Infections and infestations
Influenza
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Infections and infestations
Urinary tract infection
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Infections and infestations
Nasopharyngitis
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Infections and infestations
Oral candidiasis
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Infections and infestations
Pharyngitis
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Infections and infestations
Tonsillitis bacterial
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Infections and infestations
Tooth abscess
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Infections and infestations
Viral infection
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
3.1%
2/64 • Number of events 2 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
3.2%
2/63 • Number of events 2 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
3.2%
2/63 • Number of events 2 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
4.8%
3/63 • Number of events 3 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Injury, poisoning and procedural complications
Fall
|
3.1%
2/64 • Number of events 7 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
4.8%
3/63 • Number of events 3 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.1%
2/64 • Number of events 2 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Vascular disorders
Hypertension
|
3.1%
2/64 • Number of events 2 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Vascular disorders
Deep vein thrombosis
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Vascular disorders
Hypotension
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Vascular disorders
Orthostatic hypotension
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.1%
2/64 • Number of events 2 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Renal and urinary disorders
Renal cyst
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Renal and urinary disorders
Urinary incontinence
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Cardiac disorders
Cardiomegaly
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Ear and labyrinth disorders
Vertigo
|
3.1%
2/64 • Number of events 2 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 2 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Reproductive system and breast disorders
Pruritus genital
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Eye disorders
Diplopia
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Eye disorders
Visual acuity reduced
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Investigations
Blood pressure decreased
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Investigations
Body temperature increased
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Investigations
Weight decreased
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
1.6%
1/64 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
0.00%
0/63 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
|
Endocrine disorders
Goitre
|
0.00%
0/64 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
1.6%
1/63 • Number of events 1 • The period of monitored/assessed for the collection of AEs were through study completion, about 3 years.
|
Additional Information
Responsible of Clinical Operations
BIAL - Portela & Ca, SA
Phone: +351229866100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER