An Open-Label Extension Trial to Assess the Safety of Lon... | NCT00594165

ID	Type	Description	Link
SP512OL

Label	Type	Description	Intervention Names
Rotigotine	Experimental	Rotigotine	Drug: Rotigotine

Name	Type	Description	Arm Group Labels	Other Names
Rotigotine	Drug	Rotigotine trans-dermal patches: 10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours) Optimal dosing: During the first year: The maximum Rotigotine dose allowed is 6 mg/24 hours. After the first year: allowed dose increase of Rotigotine up to a maximum of 16 mg/24 hours.

Measure	Description	Time Frame
Number of Subjects With at Least One Adverse Event During This Open-label Extension Study	Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.	7 years

Measure	Description	Time Frame
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event.	Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.	7 years
Mean Epworth Sleepiness Scale Score During the Open-label Extension.

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

PubMed Identifier	Type	Citation	Retractions
22326237	Result	Elmer LW, Surmann E, Boroojerdi B, Jankovic J. Long-term safety and tolerability of rotigotine transdermal system in patients with early-stage idiopathic Parkinson's disease: a prospective, open-label extension study. Parkinsonism Relat Disord. 2012 Jun;18(5):488-93. doi: 10.1016/j.parkreldis.2012.01.008. Epub 2012 Feb 10.

Label	URL
FDA Safety Alerts and Recalls	View source

ID	Title	Description
FG000	Rotigotine	Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Subjects With at Least One Adverse Event During This Open-label Extension Study

Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

Of the 217 subjects who entered the study, 216 are included in this summary based on the Safety Set (SS). Subject 10806 received SP512OL study medication at the final visit of SP512DB but never returned to the clinic; this subject is excluded from the Safety Set.

Number

Subjects

7 years

ID	Title	Description
OG000	Rotigotine	Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.

Units	Counts
Participants	OG000216

Title

Denominators

Categories

Title	Measurements
	OG000214

Secondary

Number of Subjects Who Withdrew From the Trial Due to an Adverse Event.

Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

Number

subjects

7 years

ID	Title	Description
OG000	Rotigotine	Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.

Units	Counts
Participants	OG000

Secondary

Mean Epworth Sleepiness Scale Score During the Open-label Extension.

The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. The total ESS score is the sum of 8 item-scores and can range between 0 and 24. The higher the score, the higher the person's level of daytime sleepiness.

Mean

Standard Deviation

Score on a scale

Visit 9 (end of year 1), Visit 13 (end of year 2), Visit 17 (end of year 3), Visit 21(end of year 4), Visit 25 (end of year 5), Visit 29 (end of year 6), End of Treatment (last study visit or early withdrawal visit)

ID	Title	Description
OG000	Rotigotine	Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events1 affected216 at risk
Myocardial infarction	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0006 events6 affected216 at risk
Angina pectoris	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected216 at risk
Angina unstable	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected216 at risk
Coronary artery disease	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0003 events3 affected216 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected216 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected216 at risk
Arrhythmia	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0003 events3 affected216 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events2 affected216 at risk
Atrioventricular block third degree	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected216 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected216 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected216 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0001 events1 affected216 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 9.1	Non-systematic Assessment	EG0002 events1 affected216 at risk
Lower gastrointestinal haemmorrhage	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected216 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0004 events2 affected216 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected216 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected216 at risk
Abdominal strangulated hernia	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Constipation	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Faecal incontinence	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Erosive oesophagitis	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Chest pain	General disorders	MedDRA (9.1)	Non-systematic Assessment	EG0007 events6 affected216 at risk
Asthenia	General disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected216 at risk
Oedema peripheral	General disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected216 at risk
Pyrexia	General disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Application site reaction	General disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Cholangitis	Hepatobiliary disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Pneumonia	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0008 events5 affected216 at risk
Diverticulitis	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Gastroenteritis	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Appendicitis	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Urinary tract infection	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0003 events3 affected216 at risk
Infection	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0003 events2 affected216 at risk
Localised infection	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Wound infection	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Osteomyelitis	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Endocarditis	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Staphylococcal infection	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Cellulitis	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Sepsis	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0006 events5 affected216 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0003 events3 affected216 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0003 events3 affected216 at risk
Incision site haematoma	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Strernal fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Device dislocation	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Electrocardiogram ST-T change	Investigations	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Hepatic enzyme increased	Investigations	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected216 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0004 events4 affected216 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0003 events3 affected216 at risk
Scoliosis	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0003 events3 affected216 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected216 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected216 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0007 events5 affected216 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0003 events3 affected216 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected216 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0003 events1 affected216 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Acquired claw toe	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Non-systematic Assessment	EG0003 events3 affected216 at risk
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Ovarian epithelial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Renal cell carcinoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Parkinson's disease	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0007 events5 affected216 at risk
Parkinsonism	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Syncope	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0005 events4 affected216 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Somnolence	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Tremor	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected216 at risk
Carotid artery occulusion	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Dyskinesia	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Presyncope	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Nerve root compression	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Hallucination	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG0003 events3 affected216 at risk
Hallucination, visual	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Sleep attacks	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG0003 events2 affected216 at risk
Suicidal ideation	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Suicide attempt	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Abnormal behaviour	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Confusional state	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Urinary retention	Renal and urinary disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected216 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected216 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Accute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0004 events4 affected216 at risk
Obstructuve airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Spinal laminectomy	Surgical and medical procedures	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected216 at risk
Intervertebral disc operation	Surgical and medical procedures	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Cholecystectomy	Surgical and medical procedures	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA (9.1)	Non-systematic Assessment	EG0002 events1 affected216 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected216 at risk
Hypotension	Vascular disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Angiopathy	Vascular disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Haemorrhage	Vascular disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Bleeding varicose vein	Vascular disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk
Hypertension	Vascular disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected216 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (9.1)	Non-systematic Assessment	EG00019 events17 affected216 at risk
Cataract	Eye disorders	MedDRA (9.1)	Non-systematic Assessment	EG00039 events25 affected216 at risk
Nausea	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG000110 events66 affected216 at risk
Vomiting	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG00044 events26 affected216 at risk
Constipation	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG00042 events37 affected216 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG00019 events19 affected216 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG00021 events17 affected216 at risk
Dry mouth	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG00016 events15 affected216 at risk
Oedema peripheral	General disorders	MedDRA (9.1)	Non-systematic Assessment	EG000121 events79 affected216 at risk
Application site erythema	General disorders	MedDRA (9.1)	Non-systematic Assessment	EG00034 events31 affected216 at risk
Application site pruritus	General disorders	MedDRA (9.1)	Non-systematic Assessment	EG00025 events19 affected216 at risk
Application site irritation	General disorders	MedDRA (9.1)	Non-systematic Assessment	EG00014 events14 affected216 at risk
Fatigue	General disorders	MedDRA (9.1)	Non-systematic Assessment	EG00027 events24 affected216 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG00049 events33 affected216 at risk
Nasopharyngitis	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG00030 events25 affected216 at risk
Sinusitis	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG00021 events17 affected216 at risk
Urinary tract infection	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG00056 events33 affected216 at risk
Influenza	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG00018 events17 affected216 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG000142 events69 affected216 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG00014 events12 affected216 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG00018 events15 affected216 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG00020 events15 affected216 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG00016 events14 affected216 at risk
Weight decreased	Investigations	MedDRA (9.1)	Non-systematic Assessment	EG00016 events14 affected216 at risk
Blood cholesterol increased	Investigations	MedDRA (9.1)	Non-systematic Assessment	EG00011 events11 affected216 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG00069 events53 affected216 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG00063 events40 affected216 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG00012 events12 affected216 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG00082 events51 affected216 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG00016 events15 affected216 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG00025 events21 affected216 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG00016 events12 affected216 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG00012 events10 affected216 at risk
Somnolence	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG000198 events116 affected216 at risk
Dizziness	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG00080 events58 affected216 at risk
Paraesthesia	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG00023 events16 affected216 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG00021 events14 affected216 at risk
Headache	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG00032 events21 affected216 at risk
Tremor	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG00022 events19 affected216 at risk
Memory impairment	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG00014 events14 affected216 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG00017 events14 affected216 at risk
Balance disorder	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG00016 events14 affected216 at risk
Dyskinesia	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG00013 events12 affected216 at risk
Parkinson's disease	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG00012 events12 affected216 at risk
Insomnia	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG00055 events47 affected216 at risk
Depression	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG00045 events38 affected216 at risk
Anxiety	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG00028 events24 affected216 at risk
Hallucination	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG00028 events20 affected216 at risk
Confusional state	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG00019 events17 affected216 at risk
Sleep disorder	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG00016 events14 affected216 at risk
Abnormal dreams	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG00016 events13 affected216 at risk
Obsessive-compulsive disorder	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG00014 events12 affected216 at risk
Micturition urgency	Renal and urinary disorders	MedDRA (9.1)	Non-systematic Assessment	EG00014 events14 affected216 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA (9.1)	Non-systematic Assessment	EG00014 events12 affected216 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA (9.1)	Non-systematic Assessment	EG00020 events19 affected216 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG00029 events17 affected216 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG00013 events13 affected216 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG00015 events12 affected216 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG00017 events15 affected216 at risk
Hypertension	Vascular disorders	MedDRA (9.1)	Non-systematic Assessment	EG00027 events27 affected216 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (9.1)	Non-systematic Assessment	EG00014 events12 affected216 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Peoria	Arizona		United States

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