Trial Outcomes & Findings for An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease (NCT NCT00599196)
NCT ID: NCT00599196
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
381 participants
Primary outcome timeframe
six years
Results posted on
2014-10-02
Participant Flow
An Open-Label Extension to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects with Early-Stage Idiopathic Parkinson's Disease from August 2002 to December 2008
One subject was excluded from the safety set because he withdrew consent prior to receiving any Open Label study medication.
Participant milestones
| Measure |
Rotigotine
Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
|
|---|---|
|
Overall Study
STARTED
|
381
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
381
|
Reasons for withdrawal
| Measure |
Rotigotine
Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
22
|
|
Overall Study
Adverse Event
|
93
|
|
Overall Study
Unsatisfactory compliance of subject
|
3
|
|
Overall Study
Subject withdrew consent
|
43
|
|
Overall Study
Study ended per sponsor
|
197
|
|
Overall Study
Lost to Follow-up
|
17
|
|
Overall Study
Other: Patient Leaving For Israel
|
1
|
|
Overall Study
Other: Spouse Withdrew Consent
|
1
|
|
Overall Study
Other: Diagnosis No Longer Idiopathic Pd
|
1
|
|
Overall Study
Other: Pt Moved To Australia
|
1
|
|
Overall Study
Other: Patient Stopped Due To Moving
|
1
|
|
Overall Study
Other: Inv Switched Dopamine Agonist
|
1
|
Baseline Characteristics
An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Rotigotine
n=380 Participants
Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 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
|
215 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
165 Participants
n=5 Participants
|
|
Age, Continuous
|
61.6 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
150 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
230 Participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
16 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
30 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
38 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
4 participants
n=5 Participants
|
|
Region of Enrollment
France
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
44 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
65 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Croatia
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
7 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
42 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
5 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: six yearsPopulation: Of the 381 subjects who entered the study, 380 are included in this summary based on the Safety Set (SS). One subject was excluded from the safety set because he withdrew consent prior to receiving any Open Label study medication.
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=380 Participants
Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 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
|
369 Subjects
|
SECONDARY outcome
Timeframe: six yearsPopulation: Of the 381 subjects who entered the study, 380 are included in this summary based on the Safety Set (SS). One subject was excluded from the safety set because he withdrew consent prior to receiving any Open Label study medication.
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=380 Participants
Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 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
|
93 Subjects
|
SECONDARY outcome
Timeframe: Visit 10 (end of year 1), Visit 14 (end of year 2), Visit 18 (end of year 3), Visit 22 (end of year 4), Visit 26 (end of year 5), Visit 30 (end of year 6), End of Treatment (last study visit or early withdrawal visit)Population: Of the 380 subjects who are included in the Safety Set (SS), 5 subjects discontinued prior to entering the maintenance phase (n=375), however 2 of these subjects returned for the End of Treatment visit (n=377). Last observation carried forward (LOCF) was utilized for subjects who entered the maintenance phase.
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=377 Participants
Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 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 10 (end of year 1) (n=375)
|
5.8 Score on a scale
Standard Deviation 3.8
|
|
Mean Epworth Sleepiness Scale Score During the Open-label Extension
Visit 14 (end of year 2) (n=375)
|
6.2 Score on a scale
Standard Deviation 4.1
|
|
Mean Epworth Sleepiness Scale Score During the Open-label Extension
Visit 18 (end of year 3) (n=375)
|
6.7 Score on a scale
Standard Deviation 4.5
|
|
Mean Epworth Sleepiness Scale Score During the Open-label Extension
Visit 22 (end of year 4) (n=375)
|
6.7 Score on a scale
Standard Deviation 4.6
|
|
Mean Epworth Sleepiness Scale Score During the Open-label Extension
Visit 26 (end of year 5) (n=375)
|
6.7 Score on a scale
Standard Deviation 4.5
|
|
Mean Epworth Sleepiness Scale Score During the Open-label Extension
Visit 30 (end of year 6) (n=375)
|
6.8 Score on a scale
Standard Deviation 4.5
|
|
Mean Epworth Sleepiness Scale Score During the Open-label Extension
End of Treatment (n=377)
|
6.8 Score on a scale
Standard Deviation 4.5
|
Adverse Events
Rotigotine
Serious events: 131 serious events
Other events: 323 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rotigotine
n=380 participants at risk
Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 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
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Cardiac disorders
Myocardial infarction
|
2.6%
10/380 • Number of events 11 • up to 6 years
|
|
Cardiac disorders
Angina pectoris
|
0.53%
2/380 • Number of events 2 • up to 6 years
|
|
Cardiac disorders
Angina unstable
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Cardiac disorders
Acute myocardial infarction
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.53%
2/380 • Number of events 2 • up to 6 years
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.53%
2/380 • Number of events 2 • up to 6 years
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Cardiac disorders
Cardiac failure
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Cardiac disorders
Cardiac failure acute
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Cardiac disorders
Coronary artery disease
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Eye disorders
Angle closure glaucoma
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Eye disorders
Cataract
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.79%
3/380 • Number of events 3 • up to 6 years
|
|
Gastrointestinal disorders
Vomiting
|
0.53%
2/380 • Number of events 2 • up to 6 years
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.53%
2/380 • Number of events 2 • up to 6 years
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Gastrointestinal disorders
Volvulus
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Gastrointestinal disorders
Gastritis
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Gastrointestinal disorders
Constipation
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Gastrointestinal disorders
Duodenitis
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
General disorders
Application site irritation
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
General disorders
Application site rash
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
General disorders
Application site erythema
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
General disorders
Gait disturbance
|
0.53%
2/380 • Number of events 2 • up to 6 years
|
|
General disorders
Hernia
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
General disorders
Oedema peripheral
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
General disorders
Therapeutic response decreased
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
General disorders
Sudden death
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.3%
5/380 • Number of events 5 • up to 6 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.53%
2/380 • Number of events 2 • up to 6 years
|
|
Hepatobiliary disorders
Bile duct stone
|
0.53%
2/380 • Number of events 2 • up to 6 years
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Hepatobiliary disorders
Biliary tract disorder
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Immune system disorders
Autoimmune disorder
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Infections and infestations
Pneumonia
|
1.1%
4/380 • Number of events 4 • up to 6 years
|
|
Infections and infestations
Bronchitis acute
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Infections and infestations
Lobar pneumonia
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Infections and infestations
Postoperative wound infection
|
0.53%
2/380 • Number of events 2 • up to 6 years
|
|
Infections and infestations
Infection
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Infections and infestations
Wound infection
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Infections and infestations
Sepsis
|
0.53%
2/380 • Number of events 2 • up to 6 years
|
|
Infections and infestations
Urosepsis
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Infections and infestations
Pyelonephritis
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Infections and infestations
Urinary tract infection
|
0.26%
1/380 • Number of events 2 • up to 6 years
|
|
Infections and infestations
Appendicitis
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Infections and infestations
Gastroenteritis
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Infections and infestations
Meningoencephalitis herpetic
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Infections and infestations
Orchitis
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Infections and infestations
Sinusitis
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Infections and infestations
Tuberculosis
|
0.26%
1/380 • Number of events 3 • up to 6 years
|
|
Infections and infestations
Influenza
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Infections and infestations
Erysipelas
|
0.26%
1/380 • Number of events 3 • up to 6 years
|
|
Infections and infestations
Viral infection
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Injury, poisoning and procedural complications
Fall
|
2.4%
9/380 • Number of events 13 • up to 6 years
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.53%
2/380 • Number of events 2 • up to 6 years
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
1.6%
6/380 • Number of events 7 • up to 6 years
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.3%
5/380 • Number of events 5 • up to 6 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.53%
2/380 • Number of events 2 • up to 6 years
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Injury, poisoning and procedural complications
Contusion
|
0.79%
3/380 • Number of events 3 • up to 6 years
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.26%
1/380 • Number of events 2 • up to 6 years
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.53%
2/380 • Number of events 2 • up to 6 years
|
|
Injury, poisoning and procedural complications
Concussion
|
0.26%
1/380 • Number of events 2 • up to 6 years
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Injury, poisoning and procedural complications
Tooth injury
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Investigations
Hepatic enzyme increased
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.9%
11/380 • Number of events 12 • up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.26%
1/380 • Number of events 2 • up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.53%
2/380 • Number of events 2 • up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Muscle disorder
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Toe deformity
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.53%
2/380 • Number of events 3 • up to 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage unspecified
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric neoplasm
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to pleura
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Phaeochromocytoma
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Nervous system disorders
Parkinson's disease
|
2.4%
9/380 • Number of events 10 • up to 6 years
|
|
Nervous system disorders
Somnolence
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Syncope vasovagal
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dizziness
|
0.53%
2/380 • Number of events 2 • up to 6 years
|
|
Nervous system disorders
Sudden onset of sleep
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Nervous system disorders
Transient ischaemic attack
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Nervous system disorders
Tremor
|
0.26%
1/380 • Number of events 2 • up to 6 years
|
|
Nervous system disorders
Cerebrovascular accident
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Nervous system disorders
Movement disorder
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Nervous system disorders
Headache
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Nervous system disorders
Myelitis transverse
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Psychiatric disorders
Hallucination
|
1.1%
4/380 • Number of events 4 • up to 6 years
|
|
Psychiatric disorders
Hallucination, visual
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Psychiatric disorders
Depression
|
0.79%
3/380 • Number of events 3 • up to 6 years
|
|
Psychiatric disorders
Sleep attacks
|
0.53%
2/380 • Number of events 3 • up to 6 years
|
|
Psychiatric disorders
Paranoia
|
0.53%
2/380 • Number of events 2 • up to 6 years
|
|
Psychiatric disorders
Confusional state
|
0.53%
2/380 • Number of events 2 • up to 6 years
|
|
Psychiatric disorders
Impulse-control disorder
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Psychiatric disorders
Mania
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Psychiatric disorders
Psychotic disorder
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.53%
2/380 • Number of events 2 • up to 6 years
|
|
Renal and urinary disorders
Urinary incontinence
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Renal and urinary disorders
Urinary retention
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Renal and urinary disorders
Renal failure
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Renal and urinary disorders
Renal impairment
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.26%
1/380 • Number of events 2 • up to 6 years
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.53%
2/380 • Number of events 2 • up to 6 years
|
|
Reproductive system and breast disorders
Prostatitis
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.53%
2/380 • Number of events 2 • up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.53%
2/380 • Number of events 2 • up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.26%
1/380 • Number of events 2 • up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary necrosis
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.53%
2/380 • Number of events 2 • up to 6 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.53%
2/380 • Number of events 3 • up to 6 years
|
|
Surgical and medical procedures
Ankle operation
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Surgical and medical procedures
Cataract operation
|
0.53%
2/380 • Number of events 2 • up to 6 years
|
|
Surgical and medical procedures
Cholecystectomy
|
0.53%
2/380 • Number of events 2 • up to 6 years
|
|
Surgical and medical procedures
Colostomy closure
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Surgical and medical procedures
Deep brain stimulation
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Surgical and medical procedures
Lung lobectomy
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Vascular disorders
Cardiovascular insufficiency
|
0.53%
2/380 • Number of events 2 • up to 6 years
|
|
Vascular disorders
Orthostatic hypotension
|
0.53%
2/380 • Number of events 2 • up to 6 years
|
|
Vascular disorders
Hypotension
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Vascular disorders
Deep vein thrombosis
|
0.53%
2/380 • Number of events 2 • up to 6 years
|
|
Vascular disorders
Thrombophlebitis
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Vascular disorders
Aortic aneurysm
|
0.53%
2/380 • Number of events 2 • up to 6 years
|
|
Vascular disorders
Femoral arterial stenosis
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Vascular disorders
Lymphocele
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Vascular disorders
Hypertension
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
Vascular disorders
Aortic stenosis
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
|
General disorders
Chest discomfort
|
0.26%
1/380 • Number of events 1 • up to 6 years
|
Other adverse events
| Measure |
Rotigotine
n=380 participants at risk
Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
18.9%
72/380 • Number of events 115 • up to 6 years
|
|
Gastrointestinal disorders
Vomiting
|
6.6%
25/380 • Number of events 30 • up to 6 years
|
|
Gastrointestinal disorders
Constipation
|
8.9%
34/380 • Number of events 36 • up to 6 years
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
20/380 • Number of events 21 • up to 6 years
|
|
General disorders
Application site reaction
|
11.8%
45/380 • Number of events 54 • up to 6 years
|
|
General disorders
Application site pruritus
|
7.1%
27/380 • Number of events 32 • up to 6 years
|
|
General disorders
Application site erythema
|
6.8%
26/380 • Number of events 27 • up to 6 years
|
|
General disorders
Oedema peripheral
|
18.7%
71/380 • Number of events 93 • up to 6 years
|
|
General disorders
Fatigue
|
6.8%
26/380 • Number of events 30 • up to 6 years
|
|
Infections and infestations
Urinary tract infection
|
7.6%
29/380 • Number of events 41 • up to 6 years
|
|
Infections and infestations
Nasopharyngitis
|
6.3%
24/380 • Number of events 33 • up to 6 years
|
|
Infections and infestations
Influenza
|
5.3%
20/380 • Number of events 22 • up to 6 years
|
|
Injury, poisoning and procedural complications
Fall
|
11.3%
43/380 • Number of events 81 • up to 6 years
|
|
Investigations
Weight increased
|
5.0%
19/380 • Number of events 20 • up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.0%
57/380 • Number of events 78 • up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
27/380 • Number of events 36 • up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
36/380 • Number of events 48 • up to 6 years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
5.0%
19/380 • Number of events 21 • up to 6 years
|
|
Nervous system disorders
Somnolence
|
38.4%
146/380 • Number of events 234 • up to 6 years
|
|
Nervous system disorders
Dizziness
|
13.4%
51/380 • Number of events 62 • up to 6 years
|
|
Nervous system disorders
Headache
|
7.6%
29/380 • Number of events 32 • up to 6 years
|
|
Nervous system disorders
Parkinson's disease
|
6.1%
23/380 • Number of events 35 • up to 6 years
|
|
Psychiatric disorders
Insomnia
|
12.6%
48/380 • Number of events 57 • up to 6 years
|
|
Psychiatric disorders
Depression
|
10.0%
38/380 • Number of events 45 • up to 6 years
|
|
Psychiatric disorders
Hallucination
|
5.5%
21/380 • Number of events 32 • up to 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
27/380 • Number of events 31 • up to 6 years
|
|
Vascular disorders
Hypertension
|
10.8%
41/380 • Number of events 44 • up to 6 years
|
Additional Information
UCB Clinical Trial Call Center
UCB
Phone: +1 877 822 9493
Results disclosure agreements
- 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.
- Publication restrictions are in place
Restriction type: OTHER