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=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	16 Participants n=4 Participants
Age, Customized 45 to 65 years	89 Participants n=5 Participants	97 Participants n=7 Participants	95 Participants n=5 Participants	281 Participants n=4 Participants
Age, Customized >65 years	70 Participants n=5 Participants	64 Participants n=7 Participants	63 Participants n=5 Participants	197 Participants n=4 Participants
Sex: Female, Male Female	61 Participants n=5 Participants	66 Participants n=7 Participants	63 Participants n=5 Participants	190 Participants n=4 Participants
Sex: Female, Male Male	102 Participants n=5 Participants	100 Participants n=7 Participants	102 Participants n=5 Participants	304 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Month 39/Final Visit

Population: 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 Months

Population: 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 Visit

Population: 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 Visit

Population: 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 Months

Population: 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) Baseline	436.7 Microns Standard Deviation 145.88	457.4 Microns Standard Deviation 158.09	468.7 Microns Standard Deviation 129.61
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

SECONDARY outcome

Timeframe: Baseline, 39 Months

Population: 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 Visit

Population: 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 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 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 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 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
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 39/Final Visit	22.1 Percentage of Patients	18.7 Percentage of Patients	13.3 Percentage of Patients

Adverse Events

Sham

Serious events: 34 serious events

Other events: 124 other events

Deaths: 0 deaths

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

Serious adverse events

Measure	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.	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.
Cardiac disorders Cardiac Failure Congestive	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Cardiac disorders Atrioventricular Block Complete	1.2% 2/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Cardiac disorders Coronary Artery Occlusion	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Cardiac disorders Acute Myocardial Infarction	1.2% 2/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Cardiac disorders Angina Unstable	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Cardiac disorders Cardiac Arrest	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Cardiac disorders Angina Pectoris	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Cardiac disorders Arrhythmia	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Cardiac disorders Atrial Fibrillation	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Cardiac disorders Tachycardia	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Cardiac disorders Myocardial Infarction	1.2% 2/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Cardiac disorders Myocardial Ischaemia	1.2% 2/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Cardiac disorders Acute Coronary Syndrome	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Cardiac disorders Coronary Artery Disease	1.2% 2/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Cardiac disorders Ischaemic Cardiomyopathy	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Cardiac disorders Sick Sinus Syndrome	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Cardiac disorders Aortic Valve Stenosis	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Cardiac disorders Cardiac disorder	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Cardiac disorders Pleuropericarditis	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Ear and labyrinth disorders Vertigo	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Endocrine disorders Goitre	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Vitreous Haemorrhage	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Cataract	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Cataract Subcapsular	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Vitreous Adhesions	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Angle Closure Glaucoma	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Anterior Chamber Fibrin	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Corneal Erosion	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Iridocyclitis	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Lens Dislocation	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Macular oedema	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Open Angle Glaucoma	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Retinal Detachment	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Diabetic Retinal Oedema	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Pupillary Block	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Gastrointestinal disorders Intestinal Perforation	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Gastrointestinal disorders Duodenal Fistula	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Gastrointestinal disorders Gastrointestinal Ulcer Haemorrhage	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
General disorders Non-Cardiac Chest Pain	1.2% 2/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
General disorders Multi-Organ Failure	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
General disorders Drug Intolerance	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Hepatobiliary disorders Hepatic Failure	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Hepatobiliary disorders Bile Duct Stone	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Hepatobiliary disorders Liver Disorder	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Infections and infestations Cellulitis	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Infections and infestations Pneumonia	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Infections and infestations Gastroenteritis	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Infections and infestations Diabetic Foot Infection	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Infections and infestations Bronchitis	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Infections and infestations Bronchopneumonia	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Infections and infestations Infectious Peritonitis	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Infections and infestations Lung Abscess	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Infections and infestations Postoperative Wound Infection	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Infections and infestations Sepsis	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Infections and infestations Diabetic Gangrene	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Infections and infestations Urinary Tract Infection	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Infections and infestations Device Related Infection	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Infections and infestations Erysipelas	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Infections and infestations Gangrene	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Infections and infestations Abscess of Salivary Gland	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Infections and infestations H1N1 Influenza	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Infections and infestations Pharyngeal Abscess	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Infections and infestations Pneumonia Pneumococcal	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Infections and infestations Pneumonia Streptococcal	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Infections and infestations Wound Infection	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Infections and infestations Anal Abscess	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Infections and infestations Localised Infection	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Infections and infestations Osteomyelitis	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Injury, poisoning and procedural complications Chest Injury	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Injury, poisoning and procedural complications Fall	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Injury, poisoning and procedural complications Ilium Fracture	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Injury, poisoning and procedural complications Incisional Hernia	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Injury, poisoning and procedural complications Laceration	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Injury, poisoning and procedural complications Limb Injury	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Injury, poisoning and procedural complications Lower Limb Fracture	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Injury, poisoning and procedural complications Post Procedural Haemorrhage	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Injury, poisoning and procedural complications Radius Fracture	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Injury, poisoning and procedural complications Rib Fracture	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Injury, poisoning and procedural complications Foot Fracture	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Injury, poisoning and procedural complications Femur Fracture	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Injury, poisoning and procedural complications Upper Limb Fracture	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Injury, poisoning and procedural complications Chemical Eye Injury	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Injury, poisoning and procedural complications Femoral Neck Fracture	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Injury, poisoning and procedural complications Pelvic Fracture	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Injury, poisoning and procedural complications Spinal Fracture	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Injury, poisoning and procedural complications Tendon Rupture	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Injury, poisoning and procedural complications Ulna Fracture	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Injury, poisoning and procedural complications Humerus fracture	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Injury, poisoning and procedural complications Open Wound	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Injury, poisoning and procedural complications Pubis Fracture	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Injury, poisoning and procedural complications Spinal Compression Fracture	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Injury, poisoning and procedural complications Subdural Haematoma	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Investigations Blood Glucose Fluctuation	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Investigations Intraocular Pressure Increased	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Metabolism and nutrition disorders Diabetes Mellitus	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Metabolism and nutrition disorders Hypoglycaemia	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Metabolism and nutrition disorders Dehydration	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Musculoskeletal and connective tissue disorders Dupuytren's Contracture	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Musculoskeletal and connective tissue disorders Osteitis	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Musculoskeletal and connective tissue disorders Spinal Osteoarthritis	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Musculoskeletal and connective tissue disorders Intervertebral Disc Disorder	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Musculoskeletal and connective tissue disorders Rotator Cuff Syndrome	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's Lymphoma	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma Pancreas	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer Recurrent	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip Neoplasm Malignant Stage Unspecified	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Carcinoma Metastatic	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cancer	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small Cell Lung Cancer Metastatic	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	2.0% 2/102 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer Metastatic	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid Cancer	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Nervous system disorders Cerebrovascular Accident	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Nervous system disorders Transient Ischaemic Attack	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Nervous system disorders Syncope	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Nervous system disorders Carotid Artery Occlusion	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Nervous system disorders Carpal Tunnel Syndrome	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Nervous system disorders Epilepsy	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Nervous system disorders Ischaemic Stroke	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Nervous system disorders Tremor	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Nervous system disorders Carotid Artery Stenosis	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Nervous system disorders Presyncope	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Nervous system disorders Muscle Spasticity	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Renal and urinary disorders Renal Failure Acute	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Renal and urinary disorders Renal Failure	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Renal and urinary disorders Azotaemia	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Renal and urinary disorders Bladder Prolapse	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Renal and urinary disorders Renal Failure Chronic	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Distress Syndrome	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Skin and subcutaneous tissue disorders Pemphigoid	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Skin and subcutaneous tissue disorders Diabetic Foot	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Skin and subcutaneous tissue disorders Skin Ulcer	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Vascular disorders Hypertension	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Vascular disorders Peripheral Arterial Occlusive Disease	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Vascular disorders Deep Vein Thrombosis	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Vascular disorders Intermittent Claudication	0.00% 0/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Vascular disorders Aortic Aneurysm	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Vascular disorders Hypotension	0.61% 1/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.

Other adverse events

Measure	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.	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.
Investigations Intraocular Pressure Increased	4.9% 8/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Cataract	9.1% 15/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Conjunctival Haemorrhage	10.4% 17/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Macular Oedema	9.8% 16/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Cataract Subcapsular	4.9% 8/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Vitreous Haemorrhage	6.1% 10/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Vascular disorders Hypertension	7.3% 12/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Conjunctivitis	4.3% 7/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Infections and infestations Nasopharyngitis	9.8% 16/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Conjunctival Hyperaemia	5.5% 9/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Cataract Nuclear	2.4% 4/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Eye Pain	3.7% 6/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Retinal Haemorrhage	4.3% 7/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Diabetic Retinopathy	2.4% 4/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Macular fibrosis	3.7% 6/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Posterior Capsule Opacification	1.8% 3/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Dry Eye	2.4% 4/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Vitreous Floaters	1.2% 2/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Vitreous Detachment	2.4% 4/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Visual Acuity Reduced	3.7% 6/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Infections and infestations Upper Respiratory Tract Infection	6.1% 10/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Eye disorders Retinal Exudates	5.5% 9/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.
Respiratory, thoracic and mediastinal disorders Cough	1.2% 2/164 The Safety Population included all treated patients and was used for adverse event (AE) and Serious Adverse Event (SAE) reporting.	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.

Additional Information

Therapeutic Area Head,

Allergan, Inc

Phone: 714-246-4500

Email: clinicaltrials@allergan.com

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