An Open-Label Extension Trial to Assess the Safety of Lon... | NCT00501969

ID	Type	Description	Link
2004-000148-26	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Rotigotine	Experimental	Rotigotine	Drug: Rotigotine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rotigotine	Drug	Rotigotine trans-dermal patches once daily: 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours) 50 cm2 (10 mg/24 hours) 60 cm2 (12 mg/24 hours) 70 cm2 (14 mg/24 hours) 80 cm2 (16 mg/24 hours)

Outcomes Module

Primary Outcomes

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.	five years

Secondary Outcomes

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

Eligibility Module

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

Label	URL
FDA Safety Alerts and Recalls	View source

Results Section

Participant Flow Module

ID	Title	Description
FG000	Rotigotine	Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000
Between 18 and 65 years	BG000183
>=65 years	BG000

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00064.4± 9.2

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000144
Male	BG000251

Region of Enrollment

Number

participants

Title

Denominators

Categories

Finland

Title	Measurements
	BG0008

Spain

Title	Measurements
	BG000

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 395 subjects who entered the study, 395 are included in this summary based on the Safety Set (SS).

Number

Subjects

five years

ID	Title	Description
OG000	Rotigotine	Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.

Units	Counts
Participants	OG000395

Title

Denominators

Categories

Title	Measurements
	OG000357

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.

Of the 395 subjects who entered the study, 395 are included in this summary based on the Safety Set (SS).

Number

Subjects

five years

ID	Title	Description
OG000	Rotigotine	Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.

Units	Counts
Participants	OG000395

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.

Of the 395 subjects who entered the study, 395 are included in this summary based on the Safety Set (SS). Last observation carried forward (LOCF) was utilized.

Mean

Standard Deviation

Score on a scale

Visit 13 (end of year 1), Visit 17 (end of year 2), Visit 21 (end of year 3), Visit 25(end of year 4)

ID	Title	Description
OG000	Rotigotine	Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 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 events2 affected395 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Myocardial infarction	Cardiac disorders	MedDRA (9.1)	Non-systematic Assessment	EG0003 events3 affected395 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected395 at risk
Angina pectoris	Cardiac disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Cardiac failure	Cardiac disorders	MedDRA (9.1)	Non-systematic Assessment	EG0004 events4 affected395 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected395 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected395 at risk
Coronary artery disease	Cardiac disorders	MedDRA (9.1)	Non-systematic Assessment	EG0003 events3 affected395 at risk
Cardiac arrest	Cardiac disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Toxic nodular goitre	Endocrine disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Keratoconus	Eye disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Maculopathy	Eye disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected395 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Rectal prolapse	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Periodontitis	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Vomiting	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Chest pain	General disorders	MedDRA (9.1)	Non-systematic Assessment	EG0003 events3 affected395 at risk
Application site reaction	General disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected395 at risk
Gait disturbance	General disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected395 at risk
Unevaluable event	General disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Pyrexia	General disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Hernia	General disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Implant site haematoma	General disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Cholangitis	Hepatobiliary disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Transplant rejection	Immune system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Pneumonia	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0008 events7 affected395 at risk
Bronchitis acute	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Lobar pneumonia	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Urinary tract infection	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0005 events5 affected395 at risk
Cellulitis	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0003 events3 affected395 at risk
Arthritis infective	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Intervertebral discitis	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Gastroenteritis	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Sepsis	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Lower respiratory tract infection viral	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Erysipelas	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Abscess	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0003 events3 affected395 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected395 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected395 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0004 events4 affected395 at risk
Wound	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected395 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Traumatic fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Comminuted fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Narcotic intoxication	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Hepatic enzyme increased	Investigations	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Diabetes mellitus non-insulin-dependent	Metabolism and nutrition disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0005 events4 affected395 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0004 events4 affected395 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected395 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected395 at risk
Bursa disorder	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected395 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected395 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Malignant neoplasm of spinal cord	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Parkinson's disease	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG00022 events18 affected395 at risk
Parkinsonism	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0005 events4 affected395 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0003 events3 affected395 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected395 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Syncope	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0003 events3 affected395 at risk
Loss of consciousness	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected395 at risk
Radicular pain	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Cauda equina syndrome	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Dyskinesia	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected395 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected395 at risk
Sciatica	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0004 events2 affected395 at risk
Dementia	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Monoparesis	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Tremor	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Convulsion	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Sudden onset of sleep	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Dysphasia	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Hallucination	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG0004 events4 affected395 at risk
Hallucination, visual	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG0004 events4 affected395 at risk
Delirium	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events2 affected395 at risk
Obsessive-compulsive disorder	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Sleep attacks	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Delusional disorder, persecutory type	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Major depression	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Pathological gambling	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events1 affected395 at risk
Psychotic disorder	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Suicidal ideation	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Urinary retention	Renal and urinary disorders	MedDRA (9.1)	Non-systematic Assessment	EG0007 events6 affected395 at risk
Haematuria	Renal and urinary disorders	MedDRA (9.1)	Non-systematic Assessment	EG0003 events3 affected395 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Bladder disorder	Renal and urinary disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Renal colic	Renal and urinary disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (9.1)	Non-systematic Assessment	EG0003 events3 affected395 at risk
Cystocele	Reproductive system and breast disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Prostatism	Reproductive system and breast disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0004 events2 affected395 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0003 events3 affected395 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Deep brain stimulation	Surgical and medical procedures	MedDRA (9.1)	Non-systematic Assessment	EG0003 events3 affected395 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA (9.1)	Non-systematic Assessment	EG0003 events3 affected395 at risk
Drug therapy changed	Surgical and medical procedures	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Rehabilitation therapy	Surgical and medical procedures	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Cataract operation	Surgical and medical procedures	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Spinal operation	Surgical and medical procedures	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Open reduction of fracture	Surgical and medical procedures	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (9.1)	Non-systematic Assessment	EG0003 events3 affected395 at risk
Thrombophlebitis	Vascular disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Cardiovascular insufficiency	Vascular disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events1 affected395 at risk
Haematoma	Vascular disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Hypertension	Vascular disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk
Circulatory collapse	Vascular disorders	MedDRA (9.1)	Non-systematic Assessment	EG0002 events1 affected395 at risk
Aortic aneurysm	Vascular disorders	MedDRA (9.1)	Non-systematic Assessment	EG0001 events1 affected395 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG00062 events54 affected395 at risk
Constipation	Gastrointestinal disorders	MedDRA (9.1)	Non-systematic Assessment	EG00029 events26 affected395 at risk
Application site erythema	General disorders	MedDRA (9.1)	Non-systematic Assessment	EG00045 events40 affected395 at risk
Application site pruritus	General disorders	MedDRA (9.1)	Non-systematic Assessment	EG00039 events38 affected395 at risk
Application site reaction	General disorders	MedDRA (9.1)	Non-systematic Assessment	EG00032 events29 affected395 at risk
Oedema peripheral	General disorders	MedDRA (9.1)	Non-systematic Assessment	EG00035 events33 affected395 at risk
Urinary tract infection	Infections and infestations	MedDRA (9.1)	Non-systematic Assessment	EG00046 events27 affected395 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (9.1)	Non-systematic Assessment	EG000117 events61 affected395 at risk
Weight decreased	Investigations	MedDRA (9.1)	Non-systematic Assessment	EG00052 events43 affected395 at risk
Weight increased	Investigations	MedDRA (9.1)	Non-systematic Assessment	EG00032 events30 affected395 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG00057 events48 affected395 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Non-systematic Assessment	EG00036 events32 affected395 at risk
Somnolence	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG000170 events133 affected395 at risk
Dyskinesia	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG00074 events55 affected395 at risk
Parkinson's disease	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG00052 events44 affected395 at risk
Dizziness	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG00031 events27 affected395 at risk
Headache	Nervous system disorders	MedDRA (9.1)	Non-systematic Assessment	EG00033 events27 affected395 at risk
Hallucination	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG00035 events32 affected395 at risk
Hallucination, visual	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG00027 events20 affected395 at risk
Insomnia	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG00052 events45 affected395 at risk
Depression	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG00033 events31 affected395 at risk
Abnormal dreams	Psychiatric disorders	MedDRA (9.1)	Non-systematic Assessment	EG00023 events20 affected395 at risk
Orthostatic hypotension	Vascular disorders	MedDRA (9.1)	Non-systematic Assessment	EG00021 events20 affected395 at risk
Hypertension	Vascular disorders	MedDRA (9.1)	Non-systematic Assessment	EG00026 events24 affected395 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Bedford Park			Australia