Transdermal Rotigotine User Surveillance Study | NCT00599339

Label	Type	Description	Intervention Names
Neupro		Neupro at study onset
Dopamine Agonist		Other Dopamine-Agonist at study onset
L-Dopa		L-Dopa
Neupro + L-Dopa		Neupro in combination with L-Dopa at study onset
Dopamine Agonist + L-Dopa		Other Dopamine Agonist in combination with L-Dopa at study onset

Measure	Description	Time Frame
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33)	The Unified Parkinson's disease rating scale (UPDRS) Part III (Motor Examination) contains 31 questions. Each question ranges from 0 (best possible outcome) to 4 (worst outcome). The total score ranges from 0 (best possible outcome) to 124 (worst outcome).	From Baseline to Visit 7 (Month 33)

Measure	Description	Time Frame
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33)	The Unified Parkinson's disease rating scale (UPDRS) question 32 of part IV asks. "What Proportion of the waking day are dyskinesias present?" Answers range from 0 (None) to 4 (76-100 % of the day).	From Baseline to Visit 7 (Month 33)

Name	Affiliation	Role
UCB Clinical Trial Call Center	+1 877 822 9493 (UCB)	Study Director

PubMed Identifier	Type	Citation	Retractions
29484495	Result	Muller T, Tolosa E, Badea L, Asgharnejad M, Grieger F, Markowitz M, Nondonfaz X, Bauer L, Timmermann L. An observational study of rotigotine transdermal patch and other currently prescribed therapies in patients with Parkinson's disease. J Neural Transm (Vienna). 2018 Jun;125(6):953-963. doi: 10.1007/s00702-018-1860-x. Epub 2018 Feb 26.

Label	URL
Product Information	View source

ID	Title	Description
FG000	Overall	For this study, 5 groups of patients with different Parkinson's disease treatments were to be considered. Initial treatments were to include dopaminergic monotherapy with rotigotine, other dopamine agonists (eg, pramipexole, cabergoline, ropinirole), or L-dopa, treatment with L-dopa combined with rotigotine or other dopamine agonists. Treatment was to be performed according to standard medical practice. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.

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Anticipated Posting Date

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Dispersion Type

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Calculate Percentage

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Analyses

Primary

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33)

The Unified Parkinson's disease rating scale (UPDRS) Part III (Motor Examination) contains 31 questions. Each question ranges from 0 (best possible outcome) to 4 (worst outcome). The total score ranges from 0 (best possible outcome) to 124 (worst outcome).

All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).

Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.

Posted

Mean

Standard Deviation

units on a scale

From Baseline to Visit 7 (Month 33)

ID	Title	Description
OG000	Neupro Monotherapy (>= 3 Months)	This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline.
OG001	Neupro Monotherapy (< 3 Months)	This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline.
OG002	Other Dopamine Agonist (>= 3 Months)	This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline.
OG003	Other Dopamine Agonist (< 3 Months)	This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline.
OG004	L-Dopa Monotherapy (>= 3 Months)	This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline.
OG005	L-Dopa Monotherapy (< 3 Months)	This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline.
OG006	Multiple Dopamine Agonists (>= 3 Months)	This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline.
OG007	Multiple Dopamine Agonists (< 3 Months)	This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline.
OG008	Neupro + L-Dopa (>= 3 Months)	This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline.
OG009	Neupro + L-Dopa (< 3 Months)	This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline.
OG010	Other Dopamine Agonist + L-Dopa (>= 3 Months)	This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline.
OG011	Other Dopamine Agonist + L-Dopa (< 3 Months)	This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline.
OG012	Multiple Dopamine Agonists + L-Dopa (>= 3 Months)	This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline.
OG013	Multiple Dopamine Agonists + L-Dopa (< 3 Months)	This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline.
OG014	Not Treated (>= 3 Months)	This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily not treated at Baseline.
OG015	Not Treated (< 3 Months)	This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily not treated at Baseline.

Units	Counts
Participants	OG000203 OG00111 OG002145 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-2.5± 14.7 OG001-2.5± 10.3 OG002-2.2± 11.1 OG003

Secondary

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33)

The Unified Parkinson's disease rating scale (UPDRS) question 32 of part IV asks. "What Proportion of the waking day are dyskinesias present?" Answers range from 0 (None) to 4 (76-100 % of the day).

All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).

Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.

Posted

Mean

Standard Deviation

units on a scale

From Baseline to Visit 7 (Month 33)

ID	Title	Description
OG000	Neupro Monotherapy (>= 3 Months)	This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline.
OG001	Neupro Monotherapy (< 3 Months)	This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline.

Secondary

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33)

The Unified Parkinson's disease rating scale (UPDRS) Part IV question 33 asks for complications of therapy in the past week, through the question "How disabling are the dyskinesias ? " Answers range from 0 (Not disabling) to 4 (Completely disabling).

All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).

Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.

Posted

Mean

Standard Deviation

units on a scale

From Baseline to Visit 7 (Month 33)

ID	Title	Description
OG000	Neupro Monotherapy (>= 3 Months)	This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline.
OG001	Neupro Monotherapy (< 3 Months)	This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline.

Secondary

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33)

The Unified Parkinson's disease rating scale (UPDRS) Part IV question 39 asks "What proportion of the waking day is the patient "off", on average?" Answers range from 0 (None) to 4 (76-100 % of the day).

All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).

Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.

Posted

Mean

Standard Deviation

units on a scale

33 months

ID	Title	Description
OG000	Neupro Monotherapy (>= 3 Months)	This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline.
OG001	Neupro Monotherapy (< 3 Months)	This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline.

Secondary

Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33)

The NADCS assesses sleep-related motor complaints including nocturnal akinesia, dystonia and painful cramps by an ordinal severity scale.

The NADCS total score ranges from 0 (normal) to 4 (maximum severity). NADCS value was missing for one subject at Visit 7.

All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).

Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.

Posted

Mean

Standard Deviation

units on a scale

33 months

ID	Title	Description
OG000	Neupro Monotherapy (>= 3 Months)	This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline.
OG001	Neupro Monotherapy (< 3 Months)	This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline.

Secondary

Hoehn & Yahr Stage at Visit 7 (Month 33)

The Hoehn and Yahr staging of Parkinson's disease in the "on" stage, if applicable, had to be completed by the physician.

Possible staging:

0 No signs of disease
1 Unilateral disease
2 Bilateral disease without impairment of balance
3 Mild to moderate bilateral disease, some postural instability, physically dependent
4 Severe disability, still able to walk or stand unassisted
5 Wheelchair bound or bedridden unless aided

All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS).

Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.

Posted

Number

participants

33 months

ID	Title	Description
OG000	Neupro Monotherapy (>= 3 Months)	This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline.
OG001	Neupro Monotherapy (< 3 Months)	This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline.

Secondary

Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 33 Months)

The analysis was performed for the non-disjunctive classification into patients at risk to develop an Adverse Event associated with Rotigotine and patients at risk to develop an Adverse Event not associated with Rotigotine.

For analysis of Safety the patients in the Safety Set were sub-grouped into patients at risk developing an Adverse Event (AE) associated with rotigotine and patients at risk developing an AE not associated with rotigotine. This sub-grouping is non-disjunctive in nature, i.e. one patient might fall into both subgroups.

Posted

Number

Adverse Events

33 months

ID	Title	Description
OG000	Associated With Rotigotine	A patient was analyzed related to Adverse Events (AEs) associated with Rotigotine only if during the study he was at risk to develop an AE associated with Rotigotine. An Adverse Event was considered to be associated with Rotigotine if Rotigotine was administered at least once within 30 days prior to the onset of the adverse event. "Associated Event" does not necessarily mean related to treatment with Rotigotine.
OG001	Not Associated With Rotigotine	A patient was analyzed related to Adverse Events (AEs) not associated with Rotigotine only if during the study he was at risk to develop an AE not associated with Rotigotine. An adverse event was considered not to be associated with Rotigotine, if no Rotigotine was administered in the 30 days period prior to the onset of the AE.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0013 events3 affected1,328 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0010 events0 affected1,328 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Myocardial infarction	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0007 events7 affected1,390 at risk EG0017 events7 affected1,328 at risk
Angina pectoris	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0003 events3 affected1,390 at risk EG0013 events3 affected1,328 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0012 events2 affected1,328 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0012 events2 affected1,328 at risk
Angina unstable	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0011 events1 affected1,328 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Cardiac failure	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0005 events4 affected1,390 at risk EG0019 events9 affected1,328 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Cardio-respiratory distress	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Arrhythmia	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0013 events3 affected1,328 at risk
Bradycardia	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0012 events2 affected1,328 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0012 events2 affected1,328 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0012 events2 affected1,328 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0014 events4 affected1,328 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0011 events1 affected1,328 at risk
Atrial flutter	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0014 events4 affected1,328 at risk
Cardiac arrest	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0010 events0 affected1,328 at risk
Coronary artery disease	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0012 events2 affected1,328 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Coronary artery restenosis	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Atrioventricular block third degree	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0003 events3 affected1,390 at risk EG0010 events0 affected1,328 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0013 events3 affected1,328 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0011 events1 affected1,328 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0012 events2 affected1,328 at risk
Aortic valve sclerosis	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Cardiac disorder	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Palpitations	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Cardiac valve disease	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Pericardial effusion	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Atrial septal defect	Congenital, familial and genetic disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 9.1	Non-systematic Assessment	EG0003 events3 affected1,390 at risk EG0010 events0 affected1,328 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Thyroiditis	Endocrine disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Cushing's syndrome	Endocrine disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Acromegaly	Endocrine disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Goitre	Endocrine disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Hypothyroidism	Endocrine disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Cataract	Eye disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0012 events2 affected1,328 at risk
Retinal haemorrhage	Eye disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Macular degeneration	Eye disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0005 events5 affected1,390 at risk EG0015 events5 affected1,328 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0014 events3 affected1,328 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0013 events3 affected1,328 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0011 events1 affected1,328 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Constipation	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0011 events1 affected1,328 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0011 events1 affected1,328 at risk
Faecal incontinence	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Nausea	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0010 events0 affected1,328 at risk
Vomiting	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Colonic polyp	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0011 events1 affected1,328 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Gastrointestinal fistula	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Ileus	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Mechanical ileus	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Pancreatitis necrotising	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0012 events1 affected1,328 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Gastritis	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Coeliac disease	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Varices oesophageal	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Pancreatic pseudocyst	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Ascites	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Death	General disorders	MedDRA 9.1	Non-systematic Assessment	EG0007 events7 affected1,390 at risk EG0015 events5 affected1,328 at risk
Sudden death	General disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0012 events2 affected1,328 at risk
General physical health deterioration	General disorders	MedDRA 9.1	Non-systematic Assessment	EG0003 events3 affected1,390 at risk EG0012 events2 affected1,328 at risk
Orthostatic intolerance	General disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0012 events2 affected1,328 at risk
Influenza like illness	General disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Multi-organ failure	General disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Unevaluable event	General disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Chest pain	General disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0013 events3 affected1,328 at risk
Pain	General disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Oedema peripheral	General disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0012 events2 affected1,328 at risk
Gait disturbance	General disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0011 events1 affected1,328 at risk
Application site rash	General disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Fatigue	General disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Drug intolerance	General disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0012 events2 affected1,328 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0012 events2 affected1,328 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0011 events1 affected1,328 at risk
Cirrhosis alcoholic	Hepatobiliary disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Jaundice	Hepatobiliary disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Hepatitis alcoholic	Hepatobiliary disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Gallbladder disorder	Hepatobiliary disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Pneumonia	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0004 events4 affected1,390 at risk EG0018 events8 affected1,328 at risk
Bronchopneumonia	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0012 events2 affected1,328 at risk
Bronchitis acute	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Lung infection	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Gastroenteritis	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0011 events1 affected1,328 at risk
Abscess intestinal	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Appendicitis	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Rectal abscess	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Sepsis	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0014 events4 affected1,328 at risk
Urinary tract infection	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0003 events3 affected1,390 at risk EG0011 events1 affected1,328 at risk
Cystitis	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Pyelonephritis	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Urethritis	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Chronic sinusitis	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Laryngotracheo bronchitis	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Tracheobronchitis	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Staphylococcal infection	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Arthritis infective	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Intervertebral discitis	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Endocarditis	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0012 events2 affected1,328 at risk
Opportunistic infection	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Postoperative wound infection	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Gastroenteritis Norwalk virus	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Mycotoxicosis	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Helicobacter gastritis	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Herpes zoster	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Influenza	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Necrotising fasciitis	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Pseudomonas infection	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Viral infection	Infections and infestations	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0008 events8 affected1,390 at risk EG0019 events8 affected1,328 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0012 events2 affected1,328 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0005 events5 affected1,390 at risk EG0011 events1 affected1,328 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0013 events3 affected1,328 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0011 events1 affected1,328 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0012 events2 affected1,328 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0010 events0 affected1,328 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0013 events3 affected1,328 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0011 events1 affected1,328 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Dislocation of vertebra	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0012 events2 affected1,328 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0012 events2 affected1,328 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0003 events3 affected1,390 at risk EG0011 events1 affected1,328 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0010 events0 affected1,328 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Device dislocation	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0010 events0 affected1,328 at risk
Device malfunction	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Dislocation of joint prosthesis	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Implantable defibrillator malfunction	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0012 events2 affected1,328 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0011 events1 affected1,328 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Traumatic brain injury	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0013 events3 affected1,328 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Procedural site reaction	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Pharyngeal injury	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Vertebral injury	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0011 events1 affected1,328 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0012 events2 affected1,328 at risk
Feeding tube complication	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Brachial plexus injury	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Blood glucose increased	Investigations	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Prostatic specific antigen increased	Investigations	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Electrocardiogram QT corrected interval prolonged	Investigations	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Heart rate increased	Investigations	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Investigation	Investigations	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 9.1	Non-systematic Assessment	EG0007 events7 affected1,390 at risk EG0011 events1 affected1,328 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0012 events1 affected1,328 at risk
Diabetes mellitus non-insulin-dependent	Metabolism and nutrition disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0012 events2 affected1,328 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Hypochloraemia	Metabolism and nutrition disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Starvation	Metabolism and nutrition disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0009 events9 affected1,390 at risk EG00111 events10 affected1,328 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0010 events0 affected1,328 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0004 events4 affected1,390 at risk EG00110 events8 affected1,328 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Posture abnormal	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0007 events6 affected1,390 at risk EG0016 events6 affected1,328 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0012 events2 affected1,328 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0004 events4 affected1,390 at risk EG0015 events5 affected1,328 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0006 events4 affected1,390 at risk EG0010 events0 affected1,328 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Osteosclerosis	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Spinal disorder	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0012 events2 affected1,328 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0011 events1 affected1,328 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0012 events2 affected1,328 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0012 events2 affected1,328 at risk
Tendon disorder	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0004 events4 affected1,390 at risk EG0013 events3 affected1,328 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Breast cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0012 events2 affected1,328 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Metastatic carcinoma of the bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0003 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Colon cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Gastric cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Renal cell carcinoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0012 events2 affected1,328 at risk
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0011 events1 affected1,328 at risk
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Genital neoplasm malignant female	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Gastrointestinal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Meningeal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Malignant neoplasm of conjunctiva	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Oesophageal adenocarcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Gammopathy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Benign neoplasm of bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Parkinson's disease	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG00047 events39 affected1,390 at risk EG00138 events32 affected1,328 at risk
Parkinsonism	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0013 events2 affected1,328 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0008 events8 affected1,390 at risk EG0017 events7 affected1,328 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0003 events2 affected1,390 at risk EG0013 events3 affected1,328 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0016 events4 affected1,328 at risk
Ischaemic cerebral infarction	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0011 events1 affected1,328 at risk
Cerebellar haematoma	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Cerebellar infarction	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Syncope	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0009 events9 affected1,390 at risk EG0015 events4 affected1,328 at risk
Loss of consciousness	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Somnolence	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Dementia	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0004 events4 affected1,390 at risk EG0015 events5 affected1,328 at risk
Progressive supranuclear palsy	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0011 events1 affected1,328 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0014 events4 affected1,328 at risk
Cerebral hypoperfusion	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Hypokinesia	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0011 events1 affected1,328 at risk
Dyskinesia	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Movement disorder	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Multiple system atrophy	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0012 events2 affected1,328 at risk
Fine motor delay	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Nervous system disorder	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Dizziness	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0012 events2 affected1,328 at risk
Pseudoradicular syndrome	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0011 events1 affected1,328 at risk
Spinal cord haemorrhage	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0011 events1 affected1,328 at risk
Reversible ischaemic neurological deficit	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Headache	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0003 events3 affected1,390 at risk EG0010 events0 affected1,328 at risk
Sciatica	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0012 events2 affected1,328 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Tremor	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0012 events2 affected1,328 at risk
Polyneuropathy	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0012 events2 affected1,328 at risk
Coma	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Diabetic hyperosmolar coma	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Aphasia	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0010 events0 affected1,328 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Phrenic nerve paralysis	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Epilepsy	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Myoclonic epilepsy	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Autonomic nervous system imbalance	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0012 events1 affected1,328 at risk
Dystonia	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Normal pressure hydrocephalus	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Cognitive disorder	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Migraine	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Drop attacks	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Paraesthesia	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0011 events1 affected1,328 at risk
Monoparesis	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Depression	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0018 events8 affected1,328 at risk
Hallucination	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0012 events2 affected1,328 at risk
Hallucination, visual	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0011 events1 affected1,328 at risk
Confusional state	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG0004 events4 affected1,390 at risk EG0011 events1 affected1,328 at risk
Disorientation	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0011 events1 affected1,328 at risk
Anxiety	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0013 events3 affected1,328 at risk
Nervousness	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Delirium	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0011 events1 affected1,328 at risk
Sleep attacks	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0010 events0 affected1,328 at risk
Somatoform disorder	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0011 events1 affected1,328 at risk
Completed suicide	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Suicide attempt	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Anxiety disorder	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Cyclothymic disorder	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Insomnia	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Binge eating	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Impulse-control disorder	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Restlessness	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Mental disorder due to a general medical condition	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Mental status changes	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Hypersexuality	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Sleep disorder	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Post-traumatic stress disorder	Psychiatric disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0013 events3 affected1,328 at risk
Renal failure	Renal and urinary disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0011 events1 affected1,328 at risk
Acute prerenal failure	Renal and urinary disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0012 events2 affected1,328 at risk
Bladder disorder	Renal and urinary disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Neurogenic bladder	Renal and urinary disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Haematuria	Renal and urinary disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Vaginal prolapse	Reproductive system and breast disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0012 events2 affected1,328 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Epididymitis	Reproductive system and breast disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0004 events4 affected1,390 at risk EG0012 events2 affected1,328 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0004 events4 affected1,390 at risk EG0011 events1 affected1,328 at risk
Hyperventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0011 events1 affected1,328 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Pickwickian syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0003 events3 affected1,390 at risk EG0010 events0 affected1,328 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0010 events0 affected1,328 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0010 events0 affected1,328 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Pharyngeal haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Pyoderma gangrenosum	Skin and subcutaneous tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Angioneurotic oedema	Skin and subcutaneous tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Therapy regimen changed	Surgical and medical procedures	MedDRA 9.1	Non-systematic Assessment	EG0003 events3 affected1,390 at risk EG0011 events1 affected1,328 at risk
Device therapy	Surgical and medical procedures	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Drug therapy changed	Surgical and medical procedures	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Hospitalisation	Surgical and medical procedures	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Rehabilitation therapy	Surgical and medical procedures	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Deep brain stimulation	Surgical and medical procedures	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Hypertensive crisis	Vascular disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0014 events4 affected1,328 at risk
Hypertension	Vascular disorders	MedDRA 9.1	Non-systematic Assessment	EG0004 events4 affected1,390 at risk EG0012 events2 affected1,328 at risk
Femoral arterial stenosis	Vascular disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Femoral artery occlusion	Vascular disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Iliac artery stenosis	Vascular disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Subclavian artery stenosis	Vascular disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0011 events1 affected1,328 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Thrombophlebitis	Vascular disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Circulatory collapse	Vascular disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0011 events1 affected1,328 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Hypotension	Vascular disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected1,390 at risk EG0011 events1 affected1,328 at risk
Arterial occlusive disease	Vascular disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0012 events2 affected1,328 at risk
Varicose ulceration	Vascular disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Varicose vein	Vascular disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Lymphoedema	Vascular disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk
Venous thrombosis	Vascular disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected1,390 at risk EG0010 events0 affected1,328 at risk
Femoral artery aneurysm	Vascular disorders	MedDRA 9.1	Non-systematic Assessment	EG0000 events0 affected1,390 at risk EG0011 events1 affected1,328 at risk

Facility	Status	City	State	ZIP	Country	Contacts
813		Chomutov			Czechia
808

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D009069	Movement Disorders
D000080874	Synucleinopathies
D019636	Neurodegenerative Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Associated With Rotigotine	A patient was analyzed related to Adverse Events (AEs) associated with Rotigotine only if during the study he was at risk to develop an AE associated with Rotigotine. An Adverse Event was considered to be associated with Rotigotine if Rotigotine was administered at least once within 30 days prior to the onset of the adverse event. "Associated Event" does not necessarily mean related to treatment with Rotigotine.			261	1,390	237	1,390
EG001	Not Associated With Rotigotine	A patient was analyzed related to Adverse Events (AEs) not associated with Rotigotine only if during the study he was at risk to develop an AE not associated with Rotigotine. An adverse event was considered not to be associated with Rotigotine, if no Rotigotine was administered in the 30 days period prior to the onset of the AE.			269	1,328	245	1,328