Trial Outcomes & Findings for Geographic Atrophy Treatment Evaluation (NCT NCT00890097)
NCT ID: NCT00890097
Last Updated: 2014-07-03
Results Overview
The size of the retinal lesion was measured using the Heidelberg Retinal Angiography system at Baseline, Month 6, Month 12, Month 15, Month 18, Month 24, and Month 30. Images were collected in both eyes; however, one eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. Results were estimated from a longitudinal random effects regression model. A greater lesion growth rate may indicate a faster progression of the disease.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
772 participants
Primary outcome timeframe
Baseline, up to Month 30
Results posted on
2014-07-03
Participant Flow
Subjects were recruited from 48 study centers located in 14 countries.
This reporting group includes all enrolled subjects (772). A subject was considered enrolled if they met all of the inclusion criteria and none of the exclusion criteria.
Participant milestones
| Measure |
AL-8309B 1.0%
AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
|
AL-8309B 1.75%
AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
|
Vehicle
AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
|
|---|---|---|---|
|
Overall Study
STARTED
|
252
|
259
|
261
|
|
Overall Study
COMPLETED
|
184
|
173
|
184
|
|
Overall Study
NOT COMPLETED
|
68
|
86
|
77
|
Reasons for withdrawal
| Measure |
AL-8309B 1.0%
AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
|
AL-8309B 1.75%
AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
|
Vehicle
AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
21
|
32
|
28
|
|
Overall Study
Decision Unrelated to an Adverse Event
|
15
|
12
|
17
|
|
Overall Study
Withdrew Consent
|
9
|
6
|
9
|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
5
|
|
Overall Study
Noncompliance
|
0
|
4
|
4
|
|
Overall Study
Sponsor Decision
|
7
|
11
|
7
|
|
Overall Study
Did not attend final visit
|
2
|
3
|
0
|
|
Overall Study
Subject Decision
|
3
|
2
|
6
|
|
Overall Study
Randomization Error
|
2
|
0
|
0
|
|
Overall Study
Failed inclusion criteria
|
3
|
4
|
0
|
|
Overall Study
Transportation
|
0
|
2
|
0
|
|
Overall Study
Subject Moved
|
0
|
4
|
0
|
|
Overall Study
Protocol Deviation
|
1
|
1
|
1
|
Baseline Characteristics
Geographic Atrophy Treatment Evaluation
Baseline characteristics by cohort
| Measure |
AL-8309B 1.0%
n=252 Participants
AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
|
AL-8309B 1.75%
n=259 Participants
AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
|
Vehicle
n=261 Participants
AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
|
Total
n=772 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
77.9 years
STANDARD_DEVIATION 8.0 • n=99 Participants
|
78.3 years
STANDARD_DEVIATION 7.7 • n=107 Participants
|
78.8 years
STANDARD_DEVIATION 7.1 • n=206 Participants
|
78.3 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
|
Sex: Female, Male
Female
|
130 Participants
n=99 Participants
|
162 Participants
n=107 Participants
|
147 Participants
n=206 Participants
|
439 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
122 Participants
n=99 Participants
|
97 Participants
n=107 Participants
|
114 Participants
n=206 Participants
|
333 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
111 participants
n=99 Participants
|
112 participants
n=107 Participants
|
116 participants
n=206 Participants
|
339 participants
n=7 Participants
|
|
Region of Enrollment
France
|
28 participants
n=99 Participants
|
27 participants
n=107 Participants
|
29 participants
n=206 Participants
|
84 participants
n=7 Participants
|
|
Region of Enrollment
Switzerland
|
21 participants
n=99 Participants
|
21 participants
n=107 Participants
|
21 participants
n=206 Participants
|
63 participants
n=7 Participants
|
|
Region of Enrollment
Germany
|
18 participants
n=99 Participants
|
20 participants
n=107 Participants
|
19 participants
n=206 Participants
|
57 participants
n=7 Participants
|
|
Region of Enrollment
Australia
|
16 participants
n=99 Participants
|
18 participants
n=107 Participants
|
16 participants
n=206 Participants
|
50 participants
n=7 Participants
|
|
Region of Enrollment
Israel
|
13 participants
n=99 Participants
|
15 participants
n=107 Participants
|
15 participants
n=206 Participants
|
43 participants
n=7 Participants
|
|
Region of Enrollment
Italy
|
12 participants
n=99 Participants
|
15 participants
n=107 Participants
|
14 participants
n=206 Participants
|
41 participants
n=7 Participants
|
|
Region of Enrollment
Austria
|
13 participants
n=99 Participants
|
13 participants
n=107 Participants
|
14 participants
n=206 Participants
|
40 participants
n=7 Participants
|
|
Region of Enrollment
Belgium
|
7 participants
n=99 Participants
|
6 participants
n=107 Participants
|
6 participants
n=206 Participants
|
19 participants
n=7 Participants
|
|
Region of Enrollment
United Kingdom
|
4 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
10 participants
n=7 Participants
|
|
Region of Enrollment
Ireland
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
9 participants
n=7 Participants
|
|
Region of Enrollment
Japan
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
8 participants
n=7 Participants
|
|
Region of Enrollment
Portugal
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
2 participants
n=206 Participants
|
7 participants
n=7 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
2 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline, up to Month 30Population: This analysis population included all treated subjects. A subject was considered treated if they had a first or last dosing date in the database.
The size of the retinal lesion was measured using the Heidelberg Retinal Angiography system at Baseline, Month 6, Month 12, Month 15, Month 18, Month 24, and Month 30. Images were collected in both eyes; however, one eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. Results were estimated from a longitudinal random effects regression model. A greater lesion growth rate may indicate a faster progression of the disease.
Outcome measures
| Measure |
AL-8309B 1.0%
n=250 Participants
AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
|
AL-8309B 1.75%
n=258 Participants
AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
|
Vehicle
n=260 Participants
AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
|
|---|---|---|---|
|
Mean Annualized Lesion Enlargement Rate From Baseline as Assessed With Fundus Autofluorescence Imaging
|
1.725 square millimeters per year
Interval 1.595 to 1.855
|
1.758 square millimeters per year
Interval 1.626 to 1.89
|
1.707 square millimeters per year
Interval 1.585 to 1.83
|
Adverse Events
AL-8309B 1.0%
Serious events: 86 serious events
Other events: 207 other events
Deaths: 0 deaths
AL-8309B 1.75%
Serious events: 96 serious events
Other events: 212 other events
Deaths: 0 deaths
Vehicle
Serious events: 85 serious events
Other events: 207 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AL-8309B 1.0%
n=250 participants at risk
AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
|
AL-8309B 1.75%
n=258 participants at risk
AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
|
Vehicle
n=260 participants at risk
AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
|
|---|---|---|---|
|
Renal and urinary disorders
Bladder disorder
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Renal and urinary disorders
Pelvi-ureteric obstruction
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
1.2%
3/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Cardiac disorders
Acute coronary syndrome
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Cardiac disorders
Angina pectoris
|
1.6%
4/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
1.2%
3/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Cardiac disorders
Angina unstable
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
4/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
1.2%
3/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
1.9%
5/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Cardiac disorders
Atrial flutter
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Cardiac disorders
Atrioventricular block complete
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Cardiac disorders
Bundle branch block
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Cardiac disorders
Cardiac arrest
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Cardiac disorders
Cardiac disorder
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Cardiac disorders
Cardiac failure
|
0.80%
2/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
1.6%
4/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Cardiac disorders
Cardiac failure congestive
|
1.6%
4/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
1.2%
3/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.78%
2/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Cardiac disorders
Coronary artery occlusion
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Cardiac disorders
Myocardial infarction
|
1.6%
4/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Cardiac disorders
Myocardial ischaemia
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.77%
2/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Congenital, familial and genetic disorders
Choledochal cyst
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Endocrine disorders
Goitre
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Eye disorders
Cataract
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Eye disorders
Macular oedema
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Eye disorders
Retinal detachment
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Eye disorders
Visual acuity reduced
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
1.2%
3/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Gastrointestinal disorders
Gastritis
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.78%
2/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Gastrointestinal disorders
Intussusception
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Gastrointestinal disorders
Nausea
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.80%
2/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Gastrointestinal disorders
Vomiting
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
General disorders
Asthenia
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.77%
2/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
General disorders
Chest discomfort
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
General disorders
Chest pain
|
1.2%
3/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
General disorders
Death
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
General disorders
General physical health deterioration
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
General disorders
Impaired healing
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
General disorders
Inflammation
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
General disorders
Non-cardiac chest pain
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
General disorders
Pain
|
0.80%
2/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
General disorders
Pyrexia
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Hepatobiliary disorders
Biliary tract disorder
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Hepatobiliary disorders
Cirrhosis alcoholic
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Infections and infestations
Appendicitis
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Infections and infestations
Bronchitis
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Infections and infestations
Cellulitis
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Infections and infestations
Dacryocystitis
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Infections and infestations
Diverticulitis
|
1.6%
4/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Infections and infestations
Echinococciasis
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Infections and infestations
Gastroenteritis
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.77%
2/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Infections and infestations
Gastroenteritis viral
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Infections and infestations
Localised infection
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.77%
2/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Infections and infestations
Lung infection
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Infections and infestations
Pancreatic abscess
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Infections and infestations
Pneumonia
|
1.2%
3/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
3.5%
9/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
1.9%
5/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Infections and infestations
Sepsis
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
1.2%
3/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Infections and infestations
Sinusitis
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
1.2%
3/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Infections and infestations
Urosepsis
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Injury, poisoning and procedural complications
Injury
|
6.4%
16/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
5.4%
14/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
5.8%
15/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Injury, poisoning and procedural complications
Intraocular lens dislocation
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Injury, poisoning and procedural complications
Overdose
|
0.80%
2/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Investigations
Arthroscopy
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Investigations
Catheterisation cardiac
|
0.80%
2/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Investigations
Endoscopy
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Investigations
Investigation
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.77%
2/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Investigations
Renal function test abnormal
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.77%
2/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Musculoskeletal and connective tissue disorders
Kyphosis
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.80%
2/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
1.9%
5/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.77%
2/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.80%
2/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.80%
2/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac valve fibroelastoma
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant non-resectable
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage III
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage IV
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to abdominal cavity
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
1.2%
3/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma non-resectable
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.80%
2/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer metastatic
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Nervous system disorders
Cerebral haematoma
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Nervous system disorders
Cerebrovascular accident
|
1.2%
3/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
1.6%
4/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
1.2%
3/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Nervous system disorders
Convulsion
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Nervous system disorders
Dementia
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Nervous system disorders
Grand mal convulsion
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.77%
2/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Nervous system disorders
Headache
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Nervous system disorders
Loss of consciousness
|
0.80%
2/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Nervous system disorders
Sciatica
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Nervous system disorders
Syncope
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.78%
2/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.77%
2/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Nervous system disorders
Syringomyelia
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Nervous system disorders
Transient ischaemic attack
|
1.6%
4/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.78%
2/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.77%
2/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Psychiatric disorders
Depression
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Psychiatric disorders
Depression suicidal
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Psychiatric disorders
Major depression
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Psychiatric disorders
Mental status changes
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Psychiatric disorders
Schizophrenia
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Renal and urinary disorders
Renal failure acute
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Renal and urinary disorders
Renal failure chronic
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Renal and urinary disorders
Urinary retention
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
1.2%
3/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Reproductive system and breast disorders
Vaginal fistula
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
1.2%
3/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
1.6%
4/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.80%
2/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
1.2%
3/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.77%
2/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Surgical and medical procedures
Angioplasty
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Surgical and medical procedures
Aortic aneurysm repair
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Surgical and medical procedures
Aortic valve repair
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Surgical and medical procedures
Aortic valve replacement
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Surgical and medical procedures
Appendicectomy
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Surgical and medical procedures
Bunion operation
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Surgical and medical procedures
Cardioversion
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Surgical and medical procedures
Haemorrhoid operation
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.78%
2/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Surgical and medical procedures
Hip surgery
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Surgical and medical procedures
Intraocular lens implant
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Surgical and medical procedures
Intrathecal pump insertion
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Surgical and medical procedures
Joint arthroplasty
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Surgical and medical procedures
Keratoplasty
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.80%
2/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Surgical and medical procedures
Knee operation
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Surgical and medical procedures
Malignant tumour excision
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Surgical and medical procedures
Radiotherapy to eye
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Surgical and medical procedures
Salivary gland operation
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Surgical and medical procedures
Scoliosis surgery
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Surgical and medical procedures
Spinal operation
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Surgical and medical procedures
Vasodilation procedure
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Vascular disorders
Aortic stenosis
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Vascular disorders
Deep vein thrombosis
|
0.80%
2/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.39%
1/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Vascular disorders
Hypertension
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.78%
2/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Vascular disorders
Hypotension
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.40%
1/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Vascular disorders
Temporal arteritis
|
0.00%
0/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.00%
0/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
0.38%
1/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
Other adverse events
| Measure |
AL-8309B 1.0%
n=250 participants at risk
AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
|
AL-8309B 1.75%
n=258 participants at risk
AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
|
Vehicle
n=260 participants at risk
AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
|
|---|---|---|---|
|
Eye disorders
Blepharitis
|
6.0%
15/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
7.4%
19/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
2.7%
7/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Eye disorders
Cataract
|
12.0%
30/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
8.9%
23/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
8.8%
23/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Eye disorders
Choroidal neovascularisation
|
8.0%
20/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
7.8%
20/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
6.2%
16/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Eye disorders
Eye irritation
|
8.0%
20/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
10.5%
27/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
3.5%
9/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Eye disorders
Eye pain
|
6.4%
16/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
8.1%
21/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
4.2%
11/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Eye disorders
Lacrimation increased
|
3.2%
8/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
5.8%
15/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
1.2%
3/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Eye disorders
Macular degeneration
|
7.2%
18/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
7.8%
20/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
5.4%
14/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Eye disorders
Retinal haemorrhage
|
5.6%
14/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
6.2%
16/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
8.1%
21/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Eye disorders
Visual acuity reduced
|
40.4%
101/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
41.5%
107/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
41.9%
109/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Gastrointestinal disorders
Constipation
|
5.2%
13/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
1.6%
4/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
5.0%
13/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.0%
15/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
4.3%
11/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
3.5%
9/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Gastrointestinal disorders
Nausea
|
6.0%
15/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
3.1%
8/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
3.1%
8/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
General disorders
Oedema peripheral
|
5.6%
14/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
1.6%
4/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
4.2%
11/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Infections and infestations
Bronchitis
|
6.0%
15/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
8.1%
21/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
10.8%
28/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Infections and infestations
Influenza
|
2.8%
7/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
3.1%
8/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
5.4%
14/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Infections and infestations
Nasopharyngitis
|
7.6%
19/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
7.4%
19/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
8.5%
22/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Infections and infestations
Urinary tract infection
|
8.0%
20/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
10.9%
28/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
7.3%
19/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Injury, poisoning and procedural complications
Injury
|
13.6%
34/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
14.7%
38/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
11.9%
31/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
6/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
5.8%
15/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
3.5%
9/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.2%
13/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
4.7%
12/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
6.5%
17/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
5.6%
14/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
8.1%
21/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
4.6%
12/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Nervous system disorders
Headache
|
7.6%
19/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
5.8%
15/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
3.5%
9/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Psychiatric disorders
Depression
|
4.0%
10/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
3.5%
9/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
6.9%
18/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
|
Vascular disorders
Hypertension
|
9.6%
24/250 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
11.6%
30/258 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
13.8%
36/260 • Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
|
Additional Information
Dana Sager, Clinical Manager Group Leader
Alcon Research, Ltd.
Phone: 1-888-451-3937
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER