Trial Outcomes & Findings for A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema (NCT NCT00168337)
NCT ID: NCT00168337
Last Updated: 2014-08-04
Results Overview
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
554 participants
Primary outcome timeframe
Baseline, Month 39/Final Visit
Results posted on
2014-08-04
Participant Flow
Participant milestones
| Measure |
Dexamethasone 700 μg
700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
|
Dexamethasone 350 μg
350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
|
Sham
Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
188
|
181
|
185
|
|
Overall Study
COMPLETED
|
118
|
112
|
82
|
|
Overall Study
NOT COMPLETED
|
70
|
69
|
103
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema
Baseline characteristics by cohort
| Measure |
Dexamethasone 700 μg
n=188 Participants
700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
|
Dexamethasone 350 μg
n=181 Participants
350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
|
Sham
n=185 Participants
Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
|
Total
n=554 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<45 years
|
2 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
16 Participants
n=31 Participants
|
|
Age, Customized
45 to 65 years
|
116 Participants
n=39 Participants
|
109 Participants
n=41 Participants
|
108 Participants
n=35 Participants
|
333 Participants
n=31 Participants
|
|
Age, Customized
>65 years
|
70 Participants
n=39 Participants
|
64 Participants
n=41 Participants
|
71 Participants
n=35 Participants
|
205 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=39 Participants
|
75 Participants
n=41 Participants
|
70 Participants
n=35 Participants
|
222 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
111 Participants
n=39 Participants
|
106 Participants
n=41 Participants
|
115 Participants
n=35 Participants
|
332 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 39/Final VisitPopulation: Intent to Treat: all randomized patients
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.
Outcome measures
| Measure |
Dexamethasone 700 μg
n=188 Participants
700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
|
Dexamethasone 350 μg
n=181 Participants
350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
|
Sham
n=185 Participants
Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
|
|---|---|---|---|
|
Percentage of Patients With a Best Corrected Visual Acuity (BCVA) Improvement of ≥15 Letters From Baseline in the Study Eye
|
22.3 Percentage of Patients
|
18.2 Percentage of Patients
|
10.8 Percentage of Patients
|
SECONDARY outcome
Timeframe: Baseline, 39 MonthsPopulation: Intent to Treat: all randomized patients
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.
Outcome measures
| Measure |
Dexamethasone 700 μg
n=188 Participants
700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
|
Dexamethasone 350 μg
n=181 Participants
350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
|
Sham
n=185 Participants
Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
|
|---|---|---|---|
|
Average Change From Baseline in BCVA in the Study Eye
Baseline
|
55.9 Letters
Standard Deviation 9.83
|
55.2 Letters
Standard Deviation 9.69
|
57.0 Letters
Standard Deviation 8.76
|
|
Average Change From Baseline in BCVA in the Study Eye
Average Change from Baseline Over 39 months
|
2.9 Letters
Standard Deviation 8.55
|
2.9 Letters
Standard Deviation 7.67
|
2.0 Letters
Standard Deviation 8.20
|
SECONDARY outcome
Timeframe: Baseline, Month 39/Final VisitPopulation: Intent to Treat: all randomized patients
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.
Outcome measures
| Measure |
Dexamethasone 700 μg
n=188 Participants
700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
|
Dexamethasone 350 μg
n=181 Participants
350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
|
Sham
n=185 Participants
Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
|
|---|---|---|---|
|
Change From Baseline in BCVA in the Study Eye
Baseline
|
55.9 Letters
Standard Deviation 9.83
|
55.2 Letters
Standard Deviation 9.69
|
57.0 Letters
Standard Deviation 8.76
|
|
Change From Baseline in BCVA in the Study Eye
Change from Baseline at Month 39/Final Visit
|
1.3 Letters
Standard Deviation 17.03
|
1.4 Letters
Standard Deviation 15.17
|
-0.0 Letters
Standard Deviation 15.41
|
SECONDARY outcome
Timeframe: Baseline, Month 39/Final VisitPopulation: Intent to Treat: all randomized patients
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.
Outcome measures
| Measure |
Dexamethasone 700 μg
n=188 Participants
700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
|
Dexamethasone 350 μg
n=181 Participants
350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
|
Sham
n=185 Participants
Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
|
|---|---|---|---|
|
Percentage of Patients With a BCVA Improvement of ≥10 Letters From Baseline in the Study Eye
|
34.6 Percentage of Patients
|
29.8 Percentage of Patients
|
24.9 Percentage of Patients
|
SECONDARY outcome
Timeframe: Baseline, Month 39/Final VisitPopulation: Intent to Treat: all randomized patients
OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Outcome measures
| Measure |
Dexamethasone 700 μg
n=186 Participants
700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
|
Dexamethasone 350 μg
n=179 Participants
350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
|
Sham
n=177 Participants
Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
|
|---|---|---|---|
|
Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)
Baseline
|
486.0 Microns
Standard Deviation 163.12
|
475.4 Microns
Standard Deviation 160.70
|
453.7 Microns
Standard Deviation 135.36
|
|
Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)
Change from Baseline at Month 39/Final Visit
|
-117.9 Microns
Standard Deviation 227.16
|
-131.2 Microns
Standard Deviation 204.33
|
-70.4 Microns
Standard Deviation 180.82
|
POST_HOC outcome
Timeframe: Baseline, 39 MonthsPopulation: Intent to Treat: all randomized patients
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). Shorter durations of time to improvement are best. The 10th percentile represents the first 10% of patients to reach a BCVA improvement of ≥15 letters from baseline in the study eye.
Outcome measures
| Measure |
Dexamethasone 700 μg
n=188 Participants
700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
|
Dexamethasone 350 μg
n=181 Participants
350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
|
Sham
n=185 Participants
Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
|
|---|---|---|---|
|
10th Percentile for Time to BCVA Improvement of ≥15 Letters From Baseline in the Study Eye
|
50 Days
Interval 24.0 to
|
49 Days
Interval 33.0 to
|
186 Days
Interval 33.0 to
|
POST_HOC outcome
Timeframe: Baseline, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36, Month 39/Final VisitPopulation: Intent to Treat: all randomized patients
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.
Outcome measures
| Measure |
Dexamethasone 700 μg
n=188 Participants
700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
|
Dexamethasone 350 μg
n=181 Participants
350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
|
Sham
n=185 Participants
Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
|
|---|---|---|---|
|
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals
Month 21
|
15.4 Percentage of Patients
|
9.4 Percentage of Patients
|
10.3 Percentage of Patients
|
|
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals
Month 24
|
18.1 Percentage of Patients
|
9.4 Percentage of Patients
|
10.3 Percentage of Patients
|
|
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals
Month 27
|
16.5 Percentage of Patients
|
12.2 Percentage of Patients
|
10.3 Percentage of Patients
|
|
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals
Month 33
|
18.6 Percentage of Patients
|
14.4 Percentage of Patients
|
9.7 Percentage of Patients
|
|
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals
Month 39/Final Visit
|
22.3 Percentage of Patients
|
18.2 Percentage of Patients
|
10.8 Percentage of Patients
|
|
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals
Month 3
|
11.7 Percentage of Patients
|
14.4 Percentage of Patients
|
2.7 Percentage of Patients
|
|
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals
Month 6
|
8.5 Percentage of Patients
|
6.1 Percentage of Patients
|
3.2 Percentage of Patients
|
|
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals
Month 9
|
15.4 Percentage of Patients
|
14.4 Percentage of Patients
|
7.0 Percentage of Patients
|
|
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals
Month 12
|
12.8 Percentage of Patients
|
9.9 Percentage of Patients
|
9.7 Percentage of Patients
|
|
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals
Month 15
|
12.8 Percentage of Patients
|
14.4 Percentage of Patients
|
9.7 Percentage of Patients
|
|
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals
Month 18
|
12.2 Percentage of Patients
|
10.5 Percentage of Patients
|
9.2 Percentage of Patients
|
|
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals
Month 30
|
18.6 Percentage of Patients
|
12.2 Percentage of Patients
|
10.3 Percentage of Patients
|
|
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals
Month 36
|
19.7 Percentage of Patients
|
16.6 Percentage of Patients
|
10.8 Percentage of Patients
|
Adverse Events
Dexamethasone 700 μg
Serious events: 63 serious events
Other events: 180 other events
Deaths: 0 deaths
Dexamethasone 350 μg
Serious events: 68 serious events
Other events: 172 other events
Deaths: 0 deaths
Sham
Serious events: 49 serious events
Other events: 157 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dexamethasone 700 μg
n=187 participants at risk
700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
|
Dexamethasone 350 μg
n=178 participants at risk
350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
|
Sham
n=186 participants at risk
Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
|
|---|---|---|---|
|
Vascular disorders
Malignant Hypertension
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Blood and lymphatic system disorders
Anaemia of Chronic Disease
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Coronary Artery Disease
|
1.6%
3/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.7%
3/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
1.1%
2/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
3.4%
6/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Myocardial Infarction
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
2.2%
4/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.1%
2/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Angina Unstable
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Bradycardia
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Atrioventricular Block Second Degree
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Ischaemic Cardiomyopathy
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.7%
3/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Cardiac Disorder
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Coronary Artery Insufficiency
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Pulseless Electrical Activity
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Atrioventricular Block
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Ear and labyrinth disorders
Vertigo Positional
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Cataract
|
4.3%
8/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
3.9%
7/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.1%
2/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Vitreous Haemorrhage
|
4.3%
8/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.1%
2/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
2.2%
4/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Macular Oedema
|
1.1%
2/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.7%
3/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Macular Fibrosis
|
1.1%
2/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.1%
2/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Retinal Detachment
|
1.1%
2/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Cataract Subcapsular
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Glaucoma
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Necrotising Retinitis
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Open Angle Glaucoma
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Cataract Cortical
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Cystoid Macular Oedema
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Diabetic Retinal Oedema
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Diabetic Retinopathy
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Hyalosis Asteroid
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Gastrointestinal disorders
Colonic Polyp
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Gastrointestinal disorders
Gastritis
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Gastrointestinal disorders
Gastrointestinal Hypomotility
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Gastrointestinal disorders
Small Intestinal Perforation
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
General disorders
Pelvic Mass
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
General disorders
Medical Device Complication
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
General disorders
Multi-Organ Failure
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
General disorders
Sudden Death
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
General disorders
Chest Pain
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
General disorders
Device Dislocation
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.1%
2/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Hepatobiliary disorders
Hepatic Cirrhosis
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Cellulitis
|
1.6%
3/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.7%
3/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Pneumonia
|
1.1%
2/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.1%
2/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Urinary Tract Infection
|
1.1%
2/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.1%
2/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Endophthalmitis
|
1.1%
2/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Osteomyelitis
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.1%
2/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Gastroenteritis
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Arthritis Bacterial
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Bronchopneumonia
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Otitis media
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Staphylococcal Sepsis
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Urosepsis
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Incision Site Infection
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Pneumonia Viral
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Gangrene
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.1%
2/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Gallbladder Empyema
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Localised Infection
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Injury, poisoning and procedural complications
Meniscus Lesion
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Injury, poisoning and procedural complications
Cartilage Injury
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Injury, poisoning and procedural complications
Fibula Fracture
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Injury, poisoning and procedural complications
Craniocerebral Injury
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Injury, poisoning and procedural complications
Comminuted Fracture
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Injury, poisoning and procedural complications
In-Stent Coronary Artery Restenosis
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Injury, poisoning and procedural complications
Tendon Rupture
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.1%
2/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.1%
2/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.1%
2/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Musculoskeletal and connective tissue disorders
Meniscal Degeneration
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Musculoskeletal and connective tissue disorders
Spinal Column Stenosis
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.1%
2/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Musculoskeletal and connective tissue disorders
Eagles Syndrome
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Musculoskeletal and connective tissue disorders
Foot Deformity
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Musculoskeletal and connective tissue disorders
Patellofemoral Pain Syndrome
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.90%
1/111
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
2.8%
3/106
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.87%
1/115
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Gastric Neoplasm
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Squamous Cell Carcinoma Metastatic
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Squamous Cell Carcinoma Stage Unspecified
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer
|
1.3%
1/77
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/75
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/70
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional Cell Carcinoma
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Neoplasm Malignant
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.1%
2/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic Lymphocytic Leukaemia
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Nervous system disorders
Syncope
|
1.1%
2/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.1%
2/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.1%
2/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.6%
3/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Nervous system disorders
Altered State of Consciousness
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Nervous system disorders
Benign Intracranial Hypertension
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Nervous system disorders
Coma
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Nervous system disorders
Convulsion
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Nervous system disorders
Haemorrhage Intracranial
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Nervous system disorders
Haemorrhagic Stroke
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Nervous system disorders
Cerebral Ischaemia
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Nervous system disorders
VIIth Nerve Paralysis
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Nervous system disorders
Cerebral Infarction
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Nervous system disorders
Cervical Myelopathy
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Renal and urinary disorders
Renal Failure Acute
|
1.1%
2/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.1%
2/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.1%
2/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Renal and urinary disorders
Renal Failure
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Renal and urinary disorders
Cystitis Haemorrhagic
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Renal and urinary disorders
Diabetic Nephropathy
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.1%
2/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Renal and urinary disorders
Renal Failure Chronic
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.6%
3/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Renal and urinary disorders
Calculus Ureteric
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Reproductive system and breast disorders
Epididymitis
|
0.90%
1/111
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.94%
1/106
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/115
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.90%
1/111
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/106
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/115
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Reproductive system and breast disorders
Uterine Haemorrhage
|
1.3%
1/77
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/75
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/70
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.1%
2/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Social circumstances
Victim of Homicide
|
0.53%
1/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Vascular disorders
Hypertension
|
1.1%
2/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Vascular disorders
Extremity Necrosis
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Vascular disorders
Hypotension
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Vascular disorders
Hypovolaemic Shock
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Vascular disorders
Temporal Arteritis
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.56%
1/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Vascular disorders
Venous Insufficiency
|
0.00%
0/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.54%
1/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
Other adverse events
| Measure |
Dexamethasone 700 μg
n=187 participants at risk
700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
|
Dexamethasone 350 μg
n=178 participants at risk
350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
|
Sham
n=186 participants at risk
Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
|
|---|---|---|---|
|
Eye disorders
Cataract
|
41.7%
78/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
36.5%
65/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
15.6%
29/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Investigations
Intraocular Pressure Increased
|
26.7%
50/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
28.7%
51/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
8.1%
15/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Conjunctival Haemorrhage
|
20.9%
39/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
22.5%
40/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
15.1%
28/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Vascular disorders
Hypertension
|
18.7%
35/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
17.4%
31/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
8.1%
15/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Macular Oedema
|
16.0%
30/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
15.2%
27/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
10.8%
20/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Visual Acuity Reduced
|
14.4%
27/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
16.9%
30/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
6.5%
12/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Cataract Subcapsular
|
13.4%
25/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
12.4%
22/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
4.3%
8/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Diabetic Retinal Oedema
|
12.8%
24/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
12.9%
23/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
9.7%
18/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Vitreous Haemorrhage
|
11.8%
22/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
18.0%
32/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
14.0%
26/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Macular Fibrosis
|
11.2%
21/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
16.3%
29/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
6.5%
12/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Ocular Hypertension
|
10.2%
19/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
7.3%
13/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
3.2%
6/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Retinal Exudates
|
8.6%
16/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
6.7%
12/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
6.5%
12/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Dry Eye
|
8.0%
15/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
5.6%
10/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
3.8%
7/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Vitreous Detachment
|
6.4%
12/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
7.9%
14/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
4.3%
8/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Lenticular Opacities
|
6.4%
12/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
3.4%
6/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.6%
3/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Retinal Haemorrhage
|
5.9%
11/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
9.6%
17/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
4.8%
9/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Urinary Tract Infection
|
5.9%
11/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
4.5%
8/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
4.8%
9/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Diabetic Retinopathy
|
5.3%
10/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
7.9%
14/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
4.8%
9/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Conjunctival Oedema
|
5.3%
10/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
5.6%
10/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.1%
2/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
5.3%
10/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
2.2%
4/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
3.2%
6/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Conjunctival Hyperaemia
|
4.8%
9/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
6.7%
12/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
5.9%
11/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.8%
9/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
5.6%
10/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
4.3%
8/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
General disorders
Oedema Peripheral
|
4.8%
9/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
5.6%
10/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
3.2%
6/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Investigations
Blood Creatinine Increased
|
4.8%
9/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
5.1%
9/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
4.3%
8/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Eye Pain
|
4.3%
8/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
7.3%
13/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
5.4%
10/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Punctate Keratitis
|
4.3%
8/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
5.1%
9/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
3.8%
7/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Retinal Neovascularisation
|
3.2%
6/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
9.0%
16/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
7.5%
14/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Cataract Cortical
|
3.2%
6/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
6.2%
11/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
4.8%
9/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Retinal Aneurysm
|
3.2%
6/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
5.1%
9/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
2.2%
4/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.1%
4/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
7.3%
13/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
3.8%
7/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Blepharitis
|
2.1%
4/187
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.7%
3/178
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
6.5%
12/186
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER