Trial Outcomes & Findings for A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema (NCT NCT00168389)
NCT ID: NCT00168389
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
494 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
|
163
|
166
|
165
|
|
Overall Study
COMPLETED
|
107
|
118
|
70
|
|
Overall Study
NOT COMPLETED
|
56
|
48
|
95
|
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=163 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=166 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=165 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=494 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<45 years
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
|
Age, Customized
45 to 65 years
|
89 Participants
n=99 Participants
|
97 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
281 Participants
n=7 Participants
|
|
Age, Customized
>65 years
|
70 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
197 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
190 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
102 Participants
n=99 Participants
|
100 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
304 Participants
n=7 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=163 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=166 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=165 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
|
22.1 Percentage of Patients
|
18.7 Percentage of Patients
|
13.3 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=163 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=166 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=165 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
|
56.2 Letters
Standard Deviation 10.5
|
55.9 Letters
Standard Deviation 9.64
|
56.8 Letters
Standard Deviation 8.66
|
|
Average Change From Baseline in BCVA in the Study Eye
Average Change from Baseline Over 39 Months
|
4.1 Letters
Standard Deviation 8.26
|
4.3 Letters
Standard Deviation 8.49
|
1.9 Letters
Standard Deviation 7.74
|
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=163 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=166 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=165 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
|
56.2 Letters
Standard Deviation 10.5
|
55.9 Letters
Standard Deviation 9.64
|
56.8 Letters
Standard Deviation 8.66
|
|
Change From Baseline in BCVA in the Study Eye
Change from Baseline at Month 39/Final Visit
|
4.1 Letters
Standard Deviation 13.89
|
5.0 Letters
Standard Deviation 11.97
|
0.8 Letters
Standard Deviation 11.89
|
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=163 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=166 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=165 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
|
38.7 Percentage of Patients
|
34.3 Percentage of Patients
|
23.0 Percentage of Patients
|
SECONDARY outcome
Timeframe: Baseline, 39 MonthsPopulation: Intent to Treat: all randomized patients with data at the time point
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. The average OCT retinal thickness is calculated across study visits for each patient. 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=162 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=165 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=165 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 Retinal Thickness as Measured by Optical Coherence Tomography (OCT)
Average Change from Baseline Over 39 Months
|
-101.1 Microns
Standard Deviation 119.17
|
-103.9 Microns
Standard Deviation 137.88
|
-37.8 Microns
Standard Deviation 103.96
|
|
Average Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)
Baseline
|
436.7 Microns
Standard Deviation 145.88
|
457.4 Microns
Standard Deviation 158.09
|
468.7 Microns
Standard Deviation 129.61
|
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). 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=163 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=166 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=165 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 21.0 to
|
51 Days
Interval 30.0 to
|
150 Days
|
SECONDARY 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=163 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=166 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=165 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 36
|
20.9 Percentage of Patients
|
19.9 Percentage of Patients
|
12.7 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
|
22.1 Percentage of Patients
|
18.7 Percentage of Patients
|
13.3 Percentage of Patients
|
|
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals
Month 27
|
20.2 Percentage of Patients
|
19.3 Percentage of Patients
|
12.7 Percentage of Patients
|
|
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals
Month 30
|
16.6 Percentage of Patients
|
19.9 Percentage of Patients
|
11.5 Percentage of Patients
|
|
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals
Month 33
|
22.1 Percentage of Patients
|
17.5 Percentage of Patients
|
11.5 Percentage of Patients
|
|
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals
Month 3
|
14.1 Percentage of Patients
|
13.9 Percentage of Patients
|
6.1 Percentage of Patients
|
|
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals
Month 6
|
14.1 Percentage of Patients
|
10.2 Percentage of Patients
|
7.9 Percentage of Patients
|
|
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals
Month 9
|
19.0 Percentage of Patients
|
18.1 Percentage of Patients
|
8.5 Percentage of Patients
|
|
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals
Month 12
|
13.5 Percentage of Patients
|
15.1 Percentage of Patients
|
9.1 Percentage of Patients
|
|
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals
Month 15
|
15.3 Percentage of Patients
|
16.3 Percentage of Patients
|
7.3 Percentage of Patients
|
|
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals
Month 18
|
17.2 Percentage of Patients
|
9.6 Percentage of Patients
|
10.9 Percentage of Patients
|
|
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals
Month 21
|
16.6 Percentage of Patients
|
15.1 Percentage of Patients
|
9.1 Percentage of Patients
|
|
Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye at 3-month Intervals
Month 24
|
14.1 Percentage of Patients
|
15.1 Percentage of Patients
|
10.9 Percentage of Patients
|
Adverse Events
Dexamethasone 700 μg
Serious events: 52 serious events
Other events: 153 other events
Deaths: 0 deaths
Dexamethasone 350 μg
Serious events: 52 serious events
Other events: 162 other events
Deaths: 0 deaths
Sham
Serious events: 34 serious events
Other events: 124 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dexamethasone 700 μg
n=160 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=165 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=164 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.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.2%
2/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.8%
3/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Atrioventricular Block Complete
|
1.2%
2/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.2%
2/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Coronary Artery Occlusion
|
1.2%
2/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.2%
2/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Angina Unstable
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Cardiac Arrest
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Angina Pectoris
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Arrhythmia
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Tachycardia
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
3.0%
5/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.2%
2/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.2%
2/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.2%
2/164
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
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.2%
2/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.2%
2/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Ischaemic Cardiomyopathy
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
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%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Cardiac disorders
Pleuropericarditis
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
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
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Endocrine disorders
Goitre
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Vitreous Haemorrhage
|
1.2%
2/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.8%
3/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Cataract
|
1.2%
2/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.2%
2/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Cataract Subcapsular
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.2%
2/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Vitreous Adhesions
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Angle Closure Glaucoma
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Anterior Chamber Fibrin
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Corneal Erosion
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Iridocyclitis
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Lens Dislocation
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Macular oedema
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Pupillary Block
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Gastrointestinal disorders
Duodenal Fistula
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Gastrointestinal disorders
Gastrointestinal Ulcer Haemorrhage
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
General disorders
Non-Cardiac Chest Pain
|
1.2%
2/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.2%
2/164
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
|
1.2%
2/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
General disorders
Drug Intolerance
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Hepatobiliary disorders
Liver Disorder
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Cellulitis
|
1.2%
2/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.2%
2/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Pneumonia
|
1.2%
2/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.2%
2/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Gastroenteritis
|
1.2%
2/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Diabetic Foot Infection
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Bronchitis
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Bronchopneumonia
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Infectious Peritonitis
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Lung Abscess
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Postoperative Wound Infection
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Sepsis
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Diabetic Gangrene
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.2%
2/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.2%
2/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Device Related Infection
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
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%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Abscess of Salivary Gland
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
H1N1 Influenza
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Pharyngeal Abscess
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Pneumonia Pneumococcal
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Pneumonia Streptococcal
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Wound Infection
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Anal Abscess
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
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%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
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
Chest Injury
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
Fall
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
Ilium Fracture
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
Incisional Hernia
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
Laceration
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
Post Procedural Haemorrhage
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
Radius Fracture
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
Rib Fracture
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
Foot Fracture
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.2%
2/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
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
Upper Limb Fracture
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
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
Chemical Eye Injury
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
Pelvic Fracture
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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 Fracture
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
Ulna Fracture
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
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
Open Wound
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
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
Pubis Fracture
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
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%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
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
Subdural Haematoma
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Investigations
Blood Glucose Fluctuation
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Investigations
Intraocular Pressure Increased
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
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%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
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
Arthritis
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
Dupuytren's Contracture
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
Pain in Extremity
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
Spondylolisthesis
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
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
Arthralgia
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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 Osteoarthritis
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
Intervertebral Disc Disorder
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
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
Rotator Cuff Syndrome
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
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
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
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)
Non-Hodgkin's Lymphoma
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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)
Adenocarcinoma Pancreas
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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)
Basal Cell Carcinoma
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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 Recurrent
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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)
Lip Neoplasm Malignant Stage Unspecified
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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)
Pancreatic Carcinoma Metastatic
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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)
Renal Cancer
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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)
Small Cell Lung Cancer Metastatic
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
|
0.00%
0/102
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
2.0%
2/100
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
2.0%
2/102
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 Metastatic
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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)
Malignant Melanoma
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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)
Rectosigmoid Cancer
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
|
1.9%
3/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
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
|
1.2%
2/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.2%
2/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Nervous system disorders
Syncope
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
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 Occlusion
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Nervous system disorders
Epilepsy
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Nervous system disorders
Tremor
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.2%
2/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Nervous system disorders
Muscle Spasticity
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
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
|
1.2%
2/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.2%
2/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Renal and urinary disorders
Bladder Prolapse
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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 Distress Syndrome
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
Pemphigoid
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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
Diabetic Foot
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.2%
2/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
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
Skin Ulcer
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Vascular disorders
Hypertension
|
1.2%
2/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.62%
1/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
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%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Vascular disorders
Intermittent Claudication
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Vascular disorders
Aortic Aneurysm
|
0.00%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
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%
0/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.00%
0/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
0.61%
1/164
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=160 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=165 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=164 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.
|
|---|---|---|---|
|
Investigations
Intraocular Pressure Increased
|
41.2%
66/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
37.6%
62/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
4.9%
8/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Cataract
|
39.4%
63/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
36.4%
60/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
9.1%
15/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Conjunctival Haemorrhage
|
23.1%
37/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
32.1%
53/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
10.4%
17/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Macular Oedema
|
13.1%
21/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
9.1%
15/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
9.8%
16/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Cataract Subcapsular
|
12.5%
20/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
12.7%
21/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
4.9%
8/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Vitreous Haemorrhage
|
11.2%
18/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
21.2%
35/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
6.1%
10/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Vascular disorders
Hypertension
|
10.6%
17/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
11.5%
19/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
7.3%
12/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Conjunctivitis
|
9.4%
15/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
4.8%
8/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
4.3%
7/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Infections and infestations
Nasopharyngitis
|
8.1%
13/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
4.8%
8/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
9.8%
16/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Conjunctival Hyperaemia
|
7.5%
12/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
10.9%
18/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
5.5%
9/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Cataract Nuclear
|
7.5%
12/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
6.1%
10/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
2.4%
4/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Eye Pain
|
6.9%
11/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
7.3%
12/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
3.7%
6/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Retinal Haemorrhage
|
6.9%
11/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
6.7%
11/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
4.3%
7/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Diabetic Retinopathy
|
6.2%
10/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
3.0%
5/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
2.4%
4/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Macular fibrosis
|
5.6%
9/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
8.5%
14/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
3.7%
6/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Posterior Capsule Opacification
|
5.6%
9/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
7.3%
12/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.8%
3/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Dry Eye
|
5.0%
8/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
6.1%
10/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
2.4%
4/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Vitreous Floaters
|
5.0%
8/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
2.4%
4/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.2%
2/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Vitreous Detachment
|
4.4%
7/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
6.1%
10/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
2.4%
4/164
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
|
3.8%
6/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
6.7%
11/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
3.7%
6/164
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
|
3.8%
6/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
3.6%
6/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
6.1%
10/164
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
|
Eye disorders
Retinal Exudates
|
2.5%
4/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
4.2%
7/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
5.5%
9/164
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
|
1.9%
3/160
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
6.1%
10/165
The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.
|
1.2%
2/164
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