Trial Outcomes & Findings for DIabetic Retinopathy Candesartan Trials (NCT NCT00252694)

NCT ID: NCT00252694

Last Updated: 2014-06-06

Results Overview

3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11). A generlized log-rank test was used to test difference between treatments.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 4717 participants
• Primary outcome timeframe: From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.
• Results posted on: 2014-06-06

Participant Flow

First subject enrolled in the DIRECT Programme 8 June 2001 and last subject completed the DIRECT Programme 16 April 2008 mainly in hospital based clinics. A total of 4717 patients enrolled into the programme of whom 1905 patients proceeded to randomization into Study 47.

The most common reason for not being randomized was that all eligibility criteria were not fulfilled, followed by withdrawn informed consent.

Participant milestones

Measure	Candesartan Candesartan cilexetil 32 mg once daily	Placebo Placebo Comparator
Overall Study STARTED	951	954
Overall Study COMPLETED	807	800
Overall Study NOT COMPLETED	144	154

Reasons for withdrawal

Measure	Candesartan Candesartan cilexetil 32 mg once daily	Placebo Placebo Comparator
Overall Study Withdrawal by Subject	83	91
Overall Study Death	36	34
Overall Study Mostly Lost to Follow Up	8	13
Overall Study Patient Moving	17	16

Baseline Characteristics

DIabetic Retinopathy Candesartan Trials

Baseline characteristics by cohort

Measure	Candesartan n=951 Participants Candesartan cilexetil 32 mg once daily	Placebo n=954 Participants Placebo Comparator	Total n=1905 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	809 Participants n=5 Participants	808 Participants n=7 Participants	1617 Participants n=5 Participants
Age, Categorical >=65 years	142 Participants n=5 Participants	146 Participants n=7 Participants	288 Participants n=5 Participants
Age, Continuous	56.9 years STANDARD_DEVIATION 7.6 • n=5 Participants	56.8 years STANDARD_DEVIATION 7.9 • n=7 Participants	56.8 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	485 Participants n=5 Participants	472 Participants n=7 Participants	957 Participants n=5 Participants
Sex: Female, Male Male	466 Participants n=5 Participants	482 Participants n=7 Participants	948 Participants n=5 Participants
Region of Enrollment Russian Federation	162 participants n=5 Participants	165 participants n=7 Participants	327 participants n=5 Participants
Region of Enrollment Europe	419 participants n=5 Participants	438 participants n=7 Participants	857 participants n=5 Participants
Region of Enrollment Israel	188 participants n=5 Participants	173 participants n=7 Participants	361 participants n=5 Participants
Region of Enrollment South Africa	182 participants n=5 Participants	178 participants n=7 Participants	360 participants n=5 Participants

PRIMARY outcome

Timeframe: From baseline to end of study, i.e. 5 years, with visits after a half year, one year and thereafter one visit per year.

Population: The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.

3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11). A generlized log-rank test was used to test difference between treatments.

Outcome measures

Measure	Candesartan n=951 Participants Candesartan cilexetil 32 mg once daily	Placebo n=954 Participants Placebo Comparator
Number of Participants With a 3-step or Greater Increase in Early Treatment of Diabetic Retinopathy Study (EDTRS) Severity Scale	161 Participants 0.045	182 Participants 0.052

SECONDARY outcome

Timeframe: From baseline to end of study, i.e. 5 years.

Population: The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.

3 steps were defined as either a 1-step change in one eye and a 2-step change in the other eye or as a 3-step change in one eye only. EDRTS is a scale with 11 steps (1-11).

Outcome measures

Measure	Candesartan n=951 Participants Candesartan cilexetil 32 mg once daily	Placebo n=954 Participants Placebo Comparator
Number of Participants With at Least a 3 Step Improvement or a Persistent 2-step Improvement in the ETDRS Severity Scale.	180 Participants 0.054	136 Participants 0.040

SECONDARY outcome

Timeframe: From baseline to end of study, i.e. 5 years.

Population: The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.

Clinically Significant Macular Edema (CSME) and Proliferative Diabetic Retinopathy (PDR) are diagnosed via retinal photographs.

Outcome measures

Measure	Candesartan n=951 Participants Candesartan cilexetil 32 mg once daily	Placebo n=954 Participants Placebo Comparator
Number of Participants With Incident Clinically Significant Macular Edema (CSME) and/or Proliferative Diabetic Retinopathy (PDR).	192 Participants 0.06	193 Participants 0.06

SECONDARY outcome

Timeframe: From Baseline to end of study, i.e. 5 years.

Population: The population was the Intention To Treat population which includes all randomized patients with any post-randomization data.

An estimate of the slope from fitting a linear regression of log(UAER) over time (post-randomisation, yearly assessments) for each patient.

Outcome measures

Measure	Candesartan n=951 Participants Candesartan cilexetil 32 mg once daily	Placebo n=954 Participants Placebo Comparator
Rate of Change in Urinary Albumin Excretion Rate (UAER).	656 log (µg/min)/1000 year Interval 605.0 to 708.0	718 log (µg/min)/1000 year Interval 666.0 to 770.0

Adverse Events

Candesartan

Serious events: 301 serious events

Other events: 50 other events

Deaths: 0 deaths

Placebo

Serious events: 267 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	Candesartan n=949 participants at risk Candesartan cilexetil 32 mg once daily	Placebo n=953 participants at risk Placebo Comparator
Blood and lymphatic system disorders Anaemia	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Blood and lymphatic system disorders Disseminated Intravascular Coagulation	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Myocardial Infarction	2.0% 19/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	1.9% 18/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Angina Pectoris	1.8% 17/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	1.0% 10/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Acute Myocardial Infarction	0.74% 7/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	1.5% 14/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Angina Unstable	0.74% 7/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	1.0% 10/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Coronary Artery Disease	0.32% 3/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	1.0% 10/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Atrial Fibrillation	0.95% 9/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.31% 3/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Myocardial Ischaemia	0.63% 6/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.63% 6/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Acute Coronary Syndrome	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.42% 4/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Arteriosclerosis Coronary Artery	0.42% 4/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Cardiac Failure Congestive	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.42% 4/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Coronary Artery Stenosis	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.31% 3/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Cardiac Failure	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.21% 2/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Supraventricular Tachycardia	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Aortic Valve Incompetence	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Aortic Valve Stenosis	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Arrhythmia Supraventricular	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Atrial Flutter	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Atrioventricular Block Complete	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Bradycardia	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Cardiac Arrest	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Cardiac Disorder	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Cardiogenic Shock	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Cardiovascular Disorder	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Congestive Cardiomyopathy	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Coronary Artery Insufficiency	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Coronary Artery Occlusion	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Intracardiac Thrombus	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Ischaemic Cardiomyopathy	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Left Ventricular Failure	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Mitral Valve Disease	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Mitral Valve Incompetence	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Cardiac disorders Nodal Arrhythmia	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Congenital, familial and genetic disorders Hydrocele	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Congenital, familial and genetic disorders Ventricular Septal Defect	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Ear and labyrinth disorders Vertigo	0.32% 3/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.21% 2/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Ear and labyrinth disorders Tinnitus	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Ear and labyrinth disorders Vertigo Positional	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Ear and labyrinth disorders Deafness Neurosensory	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Ear and labyrinth disorders Sudden Hearing Loss	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Ear and labyrinth disorders Tympanic Membrane Perforation	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Endocrine disorders Goitre	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.21% 2/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Endocrine disorders Basedow's Disease	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Endocrine disorders Cushing's Syndrome	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Endocrine disorders Thyroid Neoplasm	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Endocrine disorders Thyroiditis Chronic	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Eye disorders Cataract	1.2% 11/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.63% 6/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Eye disorders Angle Closure Glaucoma	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Eye disorders Eye Haemorrhage	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Eye disorders Glaucoma	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Eye disorders Open Angle Glaucoma	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Eye disorders Optic Ischaemic Neuropathy	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Eye disorders Optic Nerve Cupping	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Eye disorders Retinal Artery Embolism	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Eye disorders Retinal Detachment	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Eye disorders Retinal Tear	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Eye disorders Retinal Vein Occlusion	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Eye disorders Uveitis	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Abdominal Pain	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Anal Fistula	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Gastroduodenitis	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.21% 2/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Haemorrhoids	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Inguinal Hernia	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.21% 2/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Pancreatitis Acute	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Abdominal Adhesions	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Colonic Polyp	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Constipation	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Diarrhoea	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Duodenal Polyp	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Duodenal Ulcer	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Dyspepsia	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Epigastric Discomfort	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Erosive Oesophagitis	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Food Poisoning	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Gastric Ulcer	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Gastritis	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Gastrointestinal Hypomotility	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Haemorrhoidal Haemorrhage	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Intestinal Perforation	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Nausea	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Oesophagitis	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Oesophagitis Ulcerative	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Pancreatitis	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Peritonitis	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Sigmoiditis	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Umbilical Hernia	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Gastrointestinal disorders Vomiting	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
General disorders Chest Pain	1.2% 11/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.63% 6/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
General disorders Non-Cardiac Chest Pain	0.32% 3/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
General disorders Sudden Death	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.31% 3/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
General disorders Sudden Cardiac Death	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
General disorders Cardiac Death	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
General disorders Death	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
General disorders Inflammation	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
General disorders Mass	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
General disorders Multi-Organ Failure	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
General disorders Oedema Peripheral	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Hepatobiliary disorders Cholelithiasis	0.74% 7/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.52% 5/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Hepatobiliary disorders Cholecystitis	0.32% 3/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.21% 2/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Hepatobiliary disorders Cholangitis	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Hepatobiliary disorders Cholecystitis Acute	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Hepatobiliary disorders Cholestasis	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Hepatobiliary disorders Gallbladder Perforation	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Hepatobiliary disorders Hepatic Cirrhosis	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Hepatobiliary disorders Hepatic Steatosis	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Hepatobiliary disorders Hepatitis	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Hepatobiliary disorders Jaundice	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Hepatobiliary disorders Sphincter Of Oddi Dysfunction	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Immune system disorders Hypersensitivity	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.21% 2/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Cellulitis	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.73% 7/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Pneumonia	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.63% 6/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Postoperative Wound Infection	0.53% 5/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Bronchitis	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.42% 4/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Diabetic Foot Infection	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.42% 4/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Gastroenteritis	0.42% 4/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.31% 3/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Osteomyelitis	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.31% 3/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Perianal Abscess	0.32% 3/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.21% 2/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Urinary Tract Infection	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.31% 3/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Diabetic Gangrene	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Diverticulitis	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Gangrene	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.21% 2/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Hepatitis C	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Lower Respiratory Tract Infection	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.21% 2/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Urosepsis	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.21% 2/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Viral Infection	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Abscess	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Abscess Limb	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Acute Tonsillitis	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Bronchiectasis	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Bronchopneumonia	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Cholecystitis Infective	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Epstein-Barr Virus Infection	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Erysipelas	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Gastroenteritis Viral	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Herpes Zoster Ophthalmic	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Hordeolum	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Lobar Pneumonia	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Localised Infection	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Muscle Abscess	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Osteomyelitis Chronic	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Otitis Externa	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Otitis Media	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Paronychia	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Pericarditis Infective	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Perineal Abscess	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Post Procedural Infection	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Pyelonephritis	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Salpingitis	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Scrotal Abscess	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Sepsis	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Sinusitis	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Subcutaneous Abscess	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Toxic Shock Syndrome	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Tuberculosis	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Viral Labyrinthitis	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Viral Pericarditis	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Infections and infestations Wound Infection	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Ankle Fracture	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.31% 3/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Head Injury	0.32% 3/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Road Traffic Accident	0.32% 3/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Femur Fracture	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Hand Fracture	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.21% 2/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Limb Injury	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Meniscus Lesion	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Multiple Injuries	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.21% 2/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Acetabulum Fracture	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Alcohol Poisoning	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Asphyxia	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Clavicle Fracture	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Concussion	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Dislocation Of Joint Prosthesis	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Dural Tear	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Epicondylitis	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Fall	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Foot Fracture	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Forearm Fracture	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Hip Fracture	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Humerus Fracture	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Injury	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Internal Injury	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Joint Dislocation	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Joint Injury	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Multiple Fractures	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Muscle Injury	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Peroneal Nerve Injury	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Poisoning	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Postoperative Hernia	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Rib Fracture	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Soft Tissue Injury	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Spinal Compression Fracture	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Spinal Fracture	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Sternal Fracture	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Tendon Injury	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Tendon Rupture	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Tibia Fracture	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Injury, poisoning and procedural complications Wrist Fracture	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Investigations Red Blood Cell Sedimentation Rate Increased	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Metabolism and nutrition disorders Hyperglycaemia	0.95% 9/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.73% 7/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Metabolism and nutrition disorders Diabetes Mellitus Inadequate Control	0.42% 4/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.63% 6/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Metabolism and nutrition disorders Hypoglycaemia	0.53% 5/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.63% 6/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Metabolism and nutrition disorders Diabetic Foot	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.42% 4/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Metabolism and nutrition disorders Diabetic Ketoacidosis	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.21% 2/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Metabolism and nutrition disorders Dehydration	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Metabolism and nutrition disorders Iron Deficiency	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Metabolism and nutrition disorders Ketoacidosis	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Metabolism and nutrition disorders Metabolic Acidosis	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Metabolism and nutrition disorders Obesity	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.53% 5/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.52% 5/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Back Pain	0.32% 3/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Intervertebral Disc Disorder	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.31% 3/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.32% 3/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.31% 3/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Spinal Osteoarthritis	0.32% 3/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.21% 2/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.21% 2/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Periarthritis	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Spinal Column Stenosis	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.21% 2/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Chondrocalcinosis Pyrophosphate	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Dupuytren's Contracture	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Foot Deformity	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Intervertebral Disc Degeneration	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Jaw Cyst	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Myalgia	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Osteitis	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Rheumatoid Arthritis	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Rotator Cuff Syndrome	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Musculoskeletal and connective tissue disorders Trigger Finger	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.84% 8/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.63% 6/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.42% 4/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer	0.32% 3/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer	0.32% 3/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Adenocarcinoma	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm Malignant	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.21% 2/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Carcinoma	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Leiomyoma	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.21% 2/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal Adenoma	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal Neoplasm	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-Cell Lymphoma	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Gastrointestinal Neoplasm	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Biliary Neoplasm	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer Recurrent	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain Neoplasm	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer Recurrent	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic Lymphocytic Leukaemia	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic Myeloid Leukaemia	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal Cancer Recurrent	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder Cancer	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric Cancer	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma Multiforme	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic Neoplasm Malignant	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's Disease	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Kaposi's Sarcoma	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal Cancer	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Squamous Cell Carcinoma Stage Unspecified	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphocytic Leukaemia	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Melanoma	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Bone	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloproliferative Disorder	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasal Cavity Cancer	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm Prostate	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Peripheral T-Cell Lymphoma Unspecified	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic Adenoma	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Cancer	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cancer	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Cell Carcinoma	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal Neoplasm	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin Cancer	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid Cancer	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Nervous system disorders Cerebrovascular Accident	1.1% 10/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.94% 9/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Nervous system disorders Transient Ischaemic Attack	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.63% 6/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Nervous system disorders Diabetic Neuropathy	0.42% 4/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Nervous system disorders Syncope	0.42% 4/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.21% 2/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Nervous system disorders Carpal Tunnel Syndrome	0.32% 3/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Nervous system disorders Cerebral Infarction	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.31% 3/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Nervous system disorders Ischaemic Stroke	0.32% 3/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Nervous system disorders Loss Of Consciousness	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Nervous system disorders Sciatica	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Nervous system disorders Vith Nerve Paralysis	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.21% 2/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Nervous system disorders Vertebrobasilar Insufficiency	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Nervous system disorders Brain Stem Infarction	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Nervous system disorders Cerebral Ischaemia	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Nervous system disorders Diabetic Hyperosmolar Coma	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Nervous system disorders Diabetic Neuropathic Ulcer	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Nervous system disorders Dizziness	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Nervous system disorders Embolic Stroke	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Nervous system disorders Epilepsy	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Nervous system disorders Facial Palsy	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Nervous system disorders Hemiparesis	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Nervous system disorders Ischaemic Cerebral Infarction	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Nervous system disorders Lumbar Spinal Stenosis	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Nervous system disorders Myasthenia Gravis	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Nervous system disorders Neuritis	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Nervous system disorders Neuritis Cranial	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Nervous system disorders Partial Seizures	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Nervous system disorders Radial Nerve Palsy	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Nervous system disorders Spondylitic Myelopathy	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Nervous system disorders Subarachnoid Haemorrhage	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Nervous system disorders Syncope Vasovagal	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Psychiatric disorders Depression	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.21% 2/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Psychiatric disorders Anxiety	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Psychiatric disorders Anxiety Disorder	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Psychiatric disorders Depression Suicidal	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Psychiatric disorders Generalised Anxiety Disorder	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Psychiatric disorders Major Depression	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Renal and urinary disorders Nephrolithiasis	0.32% 3/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Renal and urinary disorders Renal Colic	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.31% 3/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Renal and urinary disorders Urinary Incontinence	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Renal and urinary disorders Bladder Prolapse	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Renal and urinary disorders Calculus Ureteric	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Renal and urinary disorders Calculus Urethral	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Renal and urinary disorders Calculus Urinary	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Renal and urinary disorders Cystocele	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Renal and urinary disorders Diabetic Nephropathy	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Renal and urinary disorders Hydronephrosis	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Renal and urinary disorders Nephropathy	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Renal and urinary disorders Renal Failure Acute	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Renal and urinary disorders Stress Urinary Incontinence	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Renal and urinary disorders Ureteric Stenosis	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Renal and urinary disorders Urinary Retention	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Reproductive system and breast disorders Benign Prostatic Hyperplasia	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.21% 2/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Reproductive system and breast disorders Breast Mass	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Reproductive system and breast disorders Cervical Dysplasia	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Reproductive system and breast disorders Menorrhagia	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Reproductive system and breast disorders Ovarian Cyst	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Reproductive system and breast disorders Pelvic Peritoneal Adhesions	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Reproductive system and breast disorders Postmenopausal Haemorrhage	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Reproductive system and breast disorders Prostatitis	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Reproductive system and breast disorders Testicular Cyst	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Reproductive system and breast disorders Uterine Polyp	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Reproductive system and breast disorders Vaginal Prolapse	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Asthma	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.21% 2/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Pulmonary Oedema	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Acute Pulmonary Oedema	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Nasal Polyps	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Nasal Septum Deviation	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Pharyngeal Oedema	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Pulmonary Hypertension	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Respiratory, thoracic and mediastinal disorders Sleep Apnoea Syndrome	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Skin and subcutaneous tissue disorders Skin Ulcer	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.21% 2/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Skin and subcutaneous tissue disorders Angioedema	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Skin and subcutaneous tissue disorders Dermal Cyst	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Skin and subcutaneous tissue disorders Diabetic Neuropathic Ulcer	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Skin and subcutaneous tissue disorders Diabetic Ulcer	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Skin and subcutaneous tissue disorders Lichen Planus	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Skin and subcutaneous tissue disorders Neuropathic Ulcer	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Skin and subcutaneous tissue disorders Sebaceous Hyperplasia	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Vascular disorders Femoral Artery Occlusion	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.31% 3/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Vascular disorders Hypertension	0.32% 3/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Vascular disorders Hypertensive Crisis	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.31% 3/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Vascular disorders Aortic Arteriosclerosis	0.21% 2/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Vascular disorders Arteriosclerosis	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.21% 2/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Vascular disorders Peripheral Vascular Disorder	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.21% 2/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Vascular disorders Aortic Stenosis	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Vascular disorders Deep Vein Thrombosis	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Vascular disorders Extremity Necrosis	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Vascular disorders Hypotension	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Vascular disorders Ischaemia	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Vascular disorders Microangiopathy	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Vascular disorders Peripheral Arterial Occlusive Disease	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Vascular disorders Peripheral Ischaemia	0.11% 1/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.00% 0/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Vascular disorders Varicose Vein	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.
Vascular disorders Venous Thrombosis Limb	0.00% 0/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	0.10% 1/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.

Other adverse events

Measure	Candesartan n=949 participants at risk Candesartan cilexetil 32 mg once daily	Placebo n=953 participants at risk Placebo Comparator
Vascular disorders Hypotension	5.3% 50/949 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.	1.9% 18/953 • During treatment. The population used was the Safety population which includes all patients who received at least 1 dose of randomized study drug and for whom any post-dose data were available.

Additional Information

Niklas Berglind, GPS Atacand

AstraZeneca

Phone: +46 31 7766310

Email: ClinicalTrialTransparency@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place