Trial Outcomes & Findings for An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advance-Stage Parkinson's Disease (NCT NCT00594386)
NCT ID: NCT00594386
Last Updated: 2014-10-02
Results Overview
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
258 participants
Primary outcome timeframe
6 years
Results posted on
2014-10-02
Participant Flow
A multicenter Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's Disease with 41 sites in United States and Canada from August 2002 to December 2008
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
258
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
258
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Major protocol violation
|
2
|
|
Overall Study
Lack of Efficacy
|
12
|
|
Overall Study
Adverse Event
|
68
|
|
Overall Study
Unsatisfactory compliance of subject
|
11
|
|
Overall Study
Subject withdrew consent
|
35
|
|
Overall Study
Study ended per sponsor
|
115
|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Other: Patient went off patch (hospital)
|
1
|
|
Overall Study
Other: Subject moved to Seattle
|
1
|
|
Overall Study
Other: Subject admitted to nursing home
|
1
|
|
Overall Study
Other: Study terminated per investigator
|
2
|
|
Overall Study
Other: Sponsor closure of study
|
1
|
|
Overall Study
Other: Site terminated participation
|
1
|
|
Overall Study
Other: Patient wants prescription Neupro
|
1
|
|
Overall Study
Other: Loss of drivers license
|
1
|
Baseline Characteristics
An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advance-Stage Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Rotigotine
n=258 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
98 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
160 Participants
n=5 Participants
|
|
Age, Continuous
|
66.4 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
173 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
243 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 yearsPopulation: Of the 258 subjects who entered the study, 258 are included in this summary based on the Safety Set (SS).
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Outcome measures
| Measure |
Rotigotine
n=258 Participants
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.
|
|---|---|
|
Number of Subjects With at Least One Adverse Event During This Open-label Extension Study
|
258 Subjects
|
SECONDARY outcome
Timeframe: 6 yearsPopulation: Of the 258 subjects who entered the study, 258 are included in this summary based on the Safety Set (SS).
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Outcome measures
| Measure |
Rotigotine
n=258 Participants
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.
|
|---|---|
|
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event.
|
68 Subjects
|
SECONDARY outcome
Timeframe: Visit 11 (end of year 1), Visit 15 (end of year 2), Visit 19 (end of year 3), Visit 23 (end of year 4), Visit 27 (end of year 5), Visit 31 (end of year 6), End of Treatment (last study visit or early withdrawal visit)Population: Of the 258 subjects who entered the study, 258 are included in this summary based on the Safety Set (SS). Last observation carried forward (LOCF) was utilized.
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.
Outcome measures
| Measure |
Rotigotine
n=258 Participants
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.
|
|---|---|
|
Mean Epworth Sleepiness Scale Score During the Open-label Extension.
Visit 11 (end of year 1) (n=254)
|
8.6 Score on a scale
Standard Deviation 4.9
|
|
Mean Epworth Sleepiness Scale Score During the Open-label Extension.
Visit 15 (end of year 2) (n=254)
|
8.9 Score on a scale
Standard Deviation 4.9
|
|
Mean Epworth Sleepiness Scale Score During the Open-label Extension.
Visit 19 (end of year 3) (n=254)
|
9.3 Score on a scale
Standard Deviation 5.1
|
|
Mean Epworth Sleepiness Scale Score During the Open-label Extension.
Visit 23 (end of year 4) (n=254)
|
9.8 Score on a scale
Standard Deviation 5.2
|
|
Mean Epworth Sleepiness Scale Score During the Open-label Extension.
Visit 27 (end of year 5) (n=254)
|
9.7 Score on a scale
Standard Deviation 5.3
|
|
Mean Epworth Sleepiness Scale Score During the Open-label Extension.
Visit 31 (end of year 6) (n=254)
|
10.0 Score on a scale
Standard Deviation 5.4
|
|
Mean Epworth Sleepiness Scale Score During the Open-label Extension.
End of Treatment (n=258)
|
10.0 Score on a scale
Standard Deviation 5.4
|
Adverse Events
Rotigotine
Serious events: 165 serious events
Other events: 253 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rotigotine
n=258 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Cardiac disorders
Myocardial infarction
|
1.9%
5/258 • Number of events 5 • Up to 6 years
|
|
Cardiac disorders
Acute myocardial infarction
|
0.78%
2/258 • Number of events 2 • Up to 6 years
|
|
Cardiac disorders
Acute coronary syndrome
|
0.39%
1/258 • Number of events 2 • Up to 6 years
|
|
Cardiac disorders
Angina unstable
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Cardiac disorders
Cardiac failure congestive
|
2.7%
7/258 • Number of events 12 • Up to 6 years
|
|
Cardiac disorders
Coronary artery disease
|
2.3%
6/258 • Number of events 6 • Up to 6 years
|
|
Cardiac disorders
Coronary artery occlusion
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.78%
2/258 • Number of events 3 • Up to 6 years
|
|
Cardiac disorders
Sick sinus syndrome
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.78%
2/258 • Number of events 2 • Up to 6 years
|
|
Cardiac disorders
Bradycardia
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Cardiac disorders
Tachycardia
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Cardiac disorders
Cardiac aneurysm
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Gastrointestinal disorders
Ileus
|
1.2%
3/258 • Number of events 4 • Up to 6 years
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.78%
2/258 • Number of events 3 • Up to 6 years
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.39%
1/258 • Number of events 3 • Up to 6 years
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Gastrointestinal disorders
Constipation
|
0.78%
2/258 • Number of events 2 • Up to 6 years
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Gastrointestinal disorders
Diarrhoea
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
General disorders
Chest pain
|
3.9%
10/258 • Number of events 11 • Up to 6 years
|
|
General disorders
Pain
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
General disorders
Asthenia
|
1.2%
3/258 • Number of events 3 • Up to 6 years
|
|
General disorders
Malaise
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
General disorders
Implant site pain
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
General disorders
Mechanical complication of implant
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
General disorders
Implant site erosion
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
General disorders
Gait disturbance
|
0.78%
2/258 • Number of events 2 • Up to 6 years
|
|
General disorders
Cardiac death
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
General disorders
Pyrexia
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
General disorders
Hernia
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
General disorders
Oedema peripheral
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Hepatobiliary disorders
Cholangitis
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Hepatobiliary disorders
Jaundice
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Infections and infestations
Pneumonia
|
2.3%
6/258 • Number of events 8 • Up to 6 years
|
|
Infections and infestations
Bronchitis
|
1.2%
3/258 • Number of events 3 • Up to 6 years
|
|
Infections and infestations
Lobar pneumonia
|
1.2%
3/258 • Number of events 3 • Up to 6 years
|
|
Infections and infestations
Lower respiratory tract infection
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Infections and infestations
Bronchitis acute
|
0.39%
1/258 • Number of events 2 • Up to 6 years
|
|
Infections and infestations
Cellulitis
|
2.7%
7/258 • Number of events 8 • Up to 6 years
|
|
Infections and infestations
Arthritis bacterial
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Infections and infestations
Bacterial infection
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Infections and infestations
Pneumonia bacterial
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Infections and infestations
Urinary tract infection
|
3.1%
8/258 • Number of events 9 • Up to 6 years
|
|
Infections and infestations
Device related infection
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Infections and infestations
Localised infection
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Infections and infestations
Infection
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Infections and infestations
Catheter related infection
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Infections and infestations
Incision site abscess
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Infections and infestations
Postoperative wound infection
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Infections and infestations
Sepsis
|
0.78%
2/258 • Number of events 2 • Up to 6 years
|
|
Infections and infestations
Septic shock
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Infections and infestations
Urosepsis
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Infections and infestations
Gastroenteritis
|
0.78%
2/258 • Number of events 2 • Up to 6 years
|
|
Infections and infestations
Rectal abscess
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Infections and infestations
Extradural abscess
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Infections and infestations
Pneumonia klebsiella
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Infections and infestations
Subcutaneous abscess
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Infections and infestations
Cellulitis streptococcal
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Infections and infestations
Mastoiditis
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Infections and infestations
Staphylococcal infection
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Infections and infestations
Escherichia sepsis
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
13/258 • Number of events 14 • Up to 6 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
2.3%
6/258 • Number of events 6 • Up to 6 years
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.9%
5/258 • Number of events 5 • Up to 6 years
|
|
Injury, poisoning and procedural complications
Concussion
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.78%
2/258 • Number of events 2 • Up to 6 years
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.78%
2/258 • Number of events 2 • Up to 6 years
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.78%
2/258 • Number of events 2 • Up to 6 years
|
|
Injury, poisoning and procedural complications
Hepatic trauma
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.39%
1/258 • Number of events 4 • Up to 6 years
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.39%
1/258 • Number of events 2 • Up to 6 years
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Investigations
Haematocrit decreased
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Investigations
Haemoglobin decreased
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Metabolism and nutrition disorders
Dehydration
|
3.5%
9/258 • Number of events 9 • Up to 6 years
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.6%
4/258 • Number of events 4 • Up to 6 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
1.6%
4/258 • Number of events 4 • Up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
1.2%
3/258 • Number of events 3 • Up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.78%
2/258 • Number of events 2 • Up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
6/258 • Number of events 6 • Up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.3%
6/258 • Number of events 8 • Up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.78%
2/258 • Number of events 3 • Up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Loose body in joint
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.2%
3/258 • Number of events 3 • Up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.78%
2/258 • Number of events 3 • Up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.78%
2/258 • Number of events 2 • Up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.2%
3/258 • Number of events 3 • Up to 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage unspecified
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Nervous system disorders
Parkinson's disease
|
9.7%
25/258 • Number of events 28 • Up to 6 years
|
|
Nervous system disorders
Parkinsonian crisis
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Nervous system disorders
Cerebrovascular accident
|
3.1%
8/258 • Number of events 9 • Up to 6 years
|
|
Nervous system disorders
Embolic stroke
|
0.78%
2/258 • Number of events 2 • Up to 6 years
|
|
Nervous system disorders
Brain stem infarction
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Nervous system disorders
Syncope
|
3.1%
8/258 • Number of events 9 • Up to 6 years
|
|
Nervous system disorders
Syncope vasovagal
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Nervous system disorders
Depressed level of consciousness
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Nervous system disorders
Transient ischaemic attack
|
1.6%
4/258 • Number of events 5 • Up to 6 years
|
|
Nervous system disorders
Dyskinesia
|
1.2%
3/258 • Number of events 3 • Up to 6 years
|
|
Nervous system disorders
Akinesia
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Nervous system disorders
Dementia
|
1.2%
3/258 • Number of events 3 • Up to 6 years
|
|
Nervous system disorders
Tremor
|
0.78%
2/258 • Number of events 2 • Up to 6 years
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Nervous system disorders
Convulsion
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Nervous system disorders
Cervical myelopathy
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Nervous system disorders
Presyncope
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Psychiatric disorders
Hallucination
|
3.1%
8/258 • Number of events 8 • Up to 6 years
|
|
Psychiatric disorders
Hallucination, visual
|
0.78%
2/258 • Number of events 2 • Up to 6 years
|
|
Psychiatric disorders
Mental status changes
|
1.2%
3/258 • Number of events 3 • Up to 6 years
|
|
Psychiatric disorders
Confusional state
|
1.2%
3/258 • Number of events 3 • Up to 6 years
|
|
Psychiatric disorders
Sleep attacks
|
1.2%
3/258 • Number of events 3 • Up to 6 years
|
|
Psychiatric disorders
Agitation
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Psychiatric disorders
Anxiety
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Psychiatric disorders
Pathological gambling
|
0.78%
2/258 • Number of events 2 • Up to 6 years
|
|
Psychiatric disorders
Delirium
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Psychiatric disorders
Delusion
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Psychiatric disorders
Depression
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Psychiatric disorders
Mania
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Psychiatric disorders
Completed suicide
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Renal and urinary disorders
Renal failure acute
|
1.2%
3/258 • Number of events 3 • Up to 6 years
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Renal and urinary disorders
Renal failure chronic
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Renal and urinary disorders
Renal failure
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.78%
2/258 • Number of events 2 • Up to 6 years
|
|
Renal and urinary disorders
Urinary retention
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Renal and urinary disorders
Nephrosclerosis
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Renal and urinary disorders
Renal mass
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Renal and urinary disorders
Urethral obstruction
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Renal and urinary disorders
Haematuria
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Renal and urinary disorders
Calculus ureteric
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Reproductive system and breast disorders
Rectocele
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Reproductive system and breast disorders
Breast mass
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Reproductive system and breast disorders
Prostatitis
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
2.3%
6/258 • Number of events 6 • Up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.6%
4/258 • Number of events 6 • Up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.6%
4/258 • Number of events 4 • Up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.78%
2/258 • Number of events 2 • Up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.78%
2/258 • Number of events 2 • Up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal mass
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Surgical and medical procedures
Deep brain stimulation
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Surgical and medical procedures
Intervertebral disc operation
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Vascular disorders
Hypotension
|
1.2%
3/258 • Number of events 3 • Up to 6 years
|
|
Vascular disorders
Orthostatic hypotension
|
0.78%
2/258 • Number of events 3 • Up to 6 years
|
|
Vascular disorders
Haemorrhage
|
0.78%
2/258 • Number of events 2 • Up to 6 years
|
|
Vascular disorders
Circulatory collapse
|
0.78%
2/258 • Number of events 2 • Up to 6 years
|
|
Vascular disorders
Aortic stenosis
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
|
Vascular disorders
Deep vein thrombosis
|
0.39%
1/258 • Number of events 2 • Up to 6 years
|
|
Vascular disorders
Arteriosclerosis
|
0.39%
1/258 • Number of events 1 • Up to 6 years
|
Other adverse events
| Measure |
Rotigotine
n=258 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.0%
18/258 • Number of events 19 • Up to 6 years
|
|
Eye disorders
Cataract
|
9.3%
24/258 • Number of events 33 • Up to 6 years
|
|
Gastrointestinal disorders
Constipation
|
22.5%
58/258 • Number of events 66 • Up to 6 years
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
8.9%
23/258 • Number of events 23 • Up to 6 years
|
|
Gastrointestinal disorders
Nausea
|
23.6%
61/258 • Number of events 94 • Up to 6 years
|
|
Gastrointestinal disorders
Vomiting
|
11.2%
29/258 • Number of events 32 • Up to 6 years
|
|
Gastrointestinal disorders
Diarrhoea
|
9.7%
25/258 • Number of events 28 • Up to 6 years
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
13/258 • Number of events 17 • Up to 6 years
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
13/258 • Number of events 14 • Up to 6 years
|
|
General disorders
Application site erythema
|
14.3%
37/258 • Number of events 44 • Up to 6 years
|
|
General disorders
Application site pruritus
|
13.2%
34/258 • Number of events 35 • Up to 6 years
|
|
General disorders
Application site reaction
|
5.4%
14/258 • Number of events 16 • Up to 6 years
|
|
General disorders
Oedema peripheral
|
31.0%
80/258 • Number of events 111 • Up to 6 years
|
|
General disorders
Fatigue
|
8.5%
22/258 • Number of events 23 • Up to 6 years
|
|
General disorders
Asthenia
|
7.0%
18/258 • Number of events 20 • Up to 6 years
|
|
Infections and infestations
Upper respiratory tract infection
|
15.1%
39/258 • Number of events 51 • Up to 6 years
|
|
Infections and infestations
Nasopharyngitis
|
12.4%
32/258 • Number of events 41 • Up to 6 years
|
|
Infections and infestations
Urinary tract infection
|
21.3%
55/258 • Number of events 86 • Up to 6 years
|
|
Infections and infestations
Pneumonia
|
5.4%
14/258 • Number of events 15 • Up to 6 years
|
|
Infections and infestations
Cellulitis
|
7.0%
18/258 • Number of events 21 • Up to 6 years
|
|
Injury, poisoning and procedural complications
Fall
|
38.8%
100/258 • Number of events 198 • Up to 6 years
|
|
Injury, poisoning and procedural complications
Excoriation
|
6.6%
17/258 • Number of events 26 • Up to 6 years
|
|
Injury, poisoning and procedural complications
Contusion
|
11.2%
29/258 • Number of events 54 • Up to 6 years
|
|
Injury, poisoning and procedural complications
Skin laceration
|
8.9%
23/258 • Number of events 30 • Up to 6 years
|
|
Investigations
Weight decreased
|
9.3%
24/258 • Number of events 26 • Up to 6 years
|
|
Metabolism and nutrition disorders
Dehydration
|
5.8%
15/258 • Number of events 15 • Up to 6 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.0%
13/258 • Number of events 14 • Up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
19.8%
51/258 • Number of events 65 • Up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
17.8%
46/258 • Number of events 65 • Up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
13.6%
35/258 • Number of events 46 • Up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.6%
17/258 • Number of events 19 • Up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.3%
60/258 • Number of events 77 • Up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.3%
24/258 • Number of events 30 • Up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.6%
17/258 • Number of events 18 • Up to 6 years
|
|
Nervous system disorders
Somnolence
|
58.1%
150/258 • Number of events 236 • Up to 6 years
|
|
Nervous system disorders
Dizziness
|
23.6%
61/258 • Number of events 72 • Up to 6 years
|
|
Nervous system disorders
Hypoaesthesia
|
7.8%
20/258 • Number of events 25 • Up to 6 years
|
|
Nervous system disorders
Parkinson's disease
|
7.8%
20/258 • Number of events 22 • Up to 6 years
|
|
Nervous system disorders
Headache
|
10.9%
28/258 • Number of events 36 • Up to 6 years
|
|
Nervous system disorders
Dyskinesia
|
9.7%
25/258 • Number of events 32 • Up to 6 years
|
|
Nervous system disorders
Memory impairment
|
5.8%
15/258 • Number of events 15 • Up to 6 years
|
|
Nervous system disorders
Balance disorder
|
5.0%
13/258 • Number of events 13 • Up to 6 years
|
|
Psychiatric disorders
Hallucination
|
20.9%
54/258 • Number of events 68 • Up to 6 years
|
|
Psychiatric disorders
Insomnia
|
21.7%
56/258 • Number of events 66 • Up to 6 years
|
|
Psychiatric disorders
Depression
|
17.8%
46/258 • Number of events 51 • Up to 6 years
|
|
Psychiatric disorders
Confusional state
|
15.1%
39/258 • Number of events 44 • Up to 6 years
|
|
Psychiatric disorders
Anxiety
|
13.2%
34/258 • Number of events 38 • Up to 6 years
|
|
Renal and urinary disorders
Urinary incontinence
|
10.9%
28/258 • Number of events 30 • Up to 6 years
|
|
Renal and urinary disorders
Pollakiuria
|
6.6%
17/258 • Number of events 21 • Up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.2%
29/258 • Number of events 36 • Up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.5%
27/258 • Number of events 30 • Up to 6 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.9%
23/258 • Number of events 26 • Up to 6 years
|
|
Vascular disorders
Hypertension
|
14.0%
36/258 • Number of events 41 • Up to 6 years
|
Additional Information
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- Principal investigator is a sponsor employee UCB has \> 60 days but \<= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
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