Trial Outcomes & Findings for An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's Disease (NCT NCT00501969)
NCT ID: NCT00501969
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
395 participants
Primary outcome timeframe
five years
Results posted on
2014-10-02
Participant Flow
An Open-Label Extension to the Double-Blind SP515 (NCT00244387) Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects with Advanced-Stage Idiopathic Parkinson's Disease who are not well controlled on L-Dopa from August 2004 to December 2008
Participant milestones
| Measure |
Rotigotine
Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
|
|---|---|
|
Overall Study
STARTED
|
395
|
|
Overall Study
COMPLETED
|
189
|
|
Overall Study
NOT COMPLETED
|
206
|
Reasons for withdrawal
| Measure |
Rotigotine
Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
|
|---|---|
|
Overall Study
Major Protocol Violation
|
4
|
|
Overall Study
Lack of Efficacy
|
29
|
|
Overall Study
Adverse Event
|
76
|
|
Overall Study
Unsatisfactory compliance of subject
|
7
|
|
Overall Study
Subject withdrew consent
|
51
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Other: Tired Of Clinical Trial Process
|
1
|
|
Overall Study
Other: Sponsors Request
|
10
|
|
Overall Study
Other: Sponsor Termination at Site
|
1
|
|
Overall Study
Other: Sponsor Stopped Study
|
12
|
|
Overall Study
Other: Severe Dementia Unable Sign PIC
|
1
|
|
Overall Study
Other: Patients + Investigator Agreement
|
1
|
|
Overall Study
Other: Patient is Going to Have DBS
|
1
|
|
Overall Study
Other: Pat Pending Surgery for PD
|
1
|
|
Overall Study
Other: DX Changed - Parkinsons to PSNP
|
1
|
|
Overall Study
Other: As Required by Local EC
|
2
|
|
Overall Study
Other: Admin Request from the Sponsor
|
3
|
|
Overall Study
Other: Sponsor Termination/Commercial RX
|
1
|
Baseline Characteristics
An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Rotigotine
n=395 Participants
Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
183 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
212 Participants
n=5 Participants
|
|
Age, Continuous
|
64.4 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
144 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
251 Participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
35 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
22 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
33 participants
n=5 Participants
|
|
Region of Enrollment
France
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
50 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
65 participants
n=5 Participants
|
|
Region of Enrollment
Croatia
|
27 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
30 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
52 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
8 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
16 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: five yearsPopulation: Of the 395 subjects who entered the study, 395 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=395 Participants
Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
|
|---|---|
|
Number of Subjects With at Least One Adverse Event During This Open-label Extension Study
|
357 Subjects
|
SECONDARY outcome
Timeframe: five yearsPopulation: Of the 395 subjects who entered the study, 395 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=395 Participants
Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
|
|---|---|
|
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event
|
76 Subjects
|
SECONDARY outcome
Timeframe: Visit 13 (end of year 1), Visit 17 (end of year 2), Visit 21 (end of year 3), Visit 25(end of year 4)Population: 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.
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=395 Participants
Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
|
|---|---|
|
Mean Epworth Sleepiness Scale Score During the Open-label Extension
Visit 13 (end of year 1) (n=377)
|
7.4 Score on a scale
Standard Deviation 4.7
|
|
Mean Epworth Sleepiness Scale Score During the Open-label Extension
Visit 17 (end of year 2) (n=377)
|
7.8 Score on a scale
Standard Deviation 5.1
|
|
Mean Epworth Sleepiness Scale Score During the Open-label Extension
Visit 21 (end of year 3) (n=377)
|
8.0 Score on a scale
Standard Deviation 5.1
|
|
Mean Epworth Sleepiness Scale Score During the Open-label Extension
Visit 25 (end of year 4) (n=377)
|
8.3 Score on a scale
Standard Deviation 5.2
|
Adverse Events
Rotigotine
Serious events: 148 serious events
Other events: 305 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rotigotine
n=395 participants at risk
Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.51%
2/395 • Number of events 2 • Up to five years
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Cardiac disorders
Myocardial infarction
|
0.76%
3/395 • Number of events 3 • Up to five years
|
|
Cardiac disorders
Myocardial ischaemia
|
0.51%
2/395 • Number of events 2 • Up to five years
|
|
Cardiac disorders
Angina pectoris
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Cardiac disorders
Cardiac failure
|
1.0%
4/395 • Number of events 4 • Up to five years
|
|
Cardiac disorders
Sick sinus syndrome
|
0.51%
2/395 • Number of events 2 • Up to five years
|
|
Cardiac disorders
Atrial fibrillation
|
0.51%
2/395 • Number of events 2 • Up to five years
|
|
Cardiac disorders
Coronary artery disease
|
0.76%
3/395 • Number of events 3 • Up to five years
|
|
Cardiac disorders
Cardiac arrest
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Endocrine disorders
Toxic nodular goitre
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Eye disorders
Keratoconus
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Eye disorders
Maculopathy
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.51%
2/395 • Number of events 2 • Up to five years
|
|
Gastrointestinal disorders
Gastric perforation
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Gastrointestinal disorders
Gastric polyps
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Gastrointestinal disorders
Periodontitis
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Gastrointestinal disorders
Dysphagia
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Gastrointestinal disorders
Diarrhoea
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Gastrointestinal disorders
Vomiting
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
General disorders
Chest pain
|
0.76%
3/395 • Number of events 3 • Up to five years
|
|
General disorders
Application site reaction
|
0.51%
2/395 • Number of events 2 • Up to five years
|
|
General disorders
Gait disturbance
|
0.51%
2/395 • Number of events 2 • Up to five years
|
|
General disorders
Unevaluable event
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
General disorders
Pyrexia
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
General disorders
Hernia
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
General disorders
Implant site haematoma
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Hepatobiliary disorders
Cholangitis
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Immune system disorders
Transplant rejection
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Infections and infestations
Pneumonia
|
1.8%
7/395 • Number of events 8 • Up to five years
|
|
Infections and infestations
Bronchitis acute
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Infections and infestations
Lobar pneumonia
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Infections and infestations
Urinary tract infection
|
1.3%
5/395 • Number of events 5 • Up to five years
|
|
Infections and infestations
Cellulitis
|
0.76%
3/395 • Number of events 3 • Up to five years
|
|
Infections and infestations
Arthritis infective
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Infections and infestations
Intervertebral discitis
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Infections and infestations
Gastroenteritis
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Infections and infestations
Sepsis
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Infections and infestations
Gastroenteritis viral
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Infections and infestations
Erysipelas
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Infections and infestations
Abscess
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.76%
3/395 • Number of events 3 • Up to five years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.51%
2/395 • Number of events 2 • Up to five years
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.51%
2/395 • Number of events 2 • Up to five years
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Injury, poisoning and procedural complications
Fall
|
1.0%
4/395 • Number of events 4 • Up to five years
|
|
Injury, poisoning and procedural complications
Wound
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.51%
2/395 • Number of events 2 • Up to five years
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Injury, poisoning and procedural complications
Concussion
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Injury, poisoning and procedural complications
Narcotic intoxication
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Injury, poisoning and procedural complications
Head injury
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Injury, poisoning and procedural complications
Overdose
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Investigations
Hepatic enzyme increased
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Metabolism and nutrition disorders
Diabetes mellitus non-insulin-dependent
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.0%
4/395 • Number of events 5 • Up to five years
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
4/395 • Number of events 4 • Up to five years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.51%
2/395 • Number of events 2 • Up to five years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.51%
2/395 • Number of events 2 • Up to five years
|
|
Musculoskeletal and connective tissue disorders
Bursa disorder
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.51%
2/395 • Number of events 2 • Up to five years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.51%
2/395 • Number of events 2 • Up to five years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of spinal cord
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Nervous system disorders
Parkinson's disease
|
4.6%
18/395 • Number of events 22 • Up to five years
|
|
Nervous system disorders
Parkinsonism
|
1.0%
4/395 • Number of events 5 • Up to five years
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.76%
3/395 • Number of events 3 • Up to five years
|
|
Nervous system disorders
Cerebrovascular accident
|
0.51%
2/395 • Number of events 2 • Up to five years
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Nervous system disorders
Syncope
|
0.76%
3/395 • Number of events 3 • Up to five years
|
|
Nervous system disorders
Loss of consciousness
|
0.51%
2/395 • Number of events 2 • Up to five years
|
|
Nervous system disorders
Radicular pain
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Nervous system disorders
Cauda equina syndrome
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Nervous system disorders
Dyskinesia
|
0.51%
2/395 • Number of events 2 • Up to five years
|
|
Nervous system disorders
Transient ischaemic attack
|
0.51%
2/395 • Number of events 2 • Up to five years
|
|
Nervous system disorders
Sciatica
|
0.51%
2/395 • Number of events 4 • Up to five years
|
|
Nervous system disorders
Dementia
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Nervous system disorders
Monoparesis
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Nervous system disorders
Neuropathy peripheral
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Nervous system disorders
Tremor
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Nervous system disorders
Convulsion
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Nervous system disorders
Sudden onset of sleep
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Nervous system disorders
Dysphasia
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Psychiatric disorders
Hallucination
|
1.0%
4/395 • Number of events 4 • Up to five years
|
|
Psychiatric disorders
Hallucination, visual
|
1.0%
4/395 • Number of events 4 • Up to five years
|
|
Psychiatric disorders
Delirium
|
0.51%
2/395 • Number of events 2 • Up to five years
|
|
Psychiatric disorders
Obsessive-compulsive disorder
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Psychiatric disorders
Sleep attacks
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Psychiatric disorders
Delusional disorder, persecutory type
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Psychiatric disorders
Major depression
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Psychiatric disorders
Pathological gambling
|
0.25%
1/395 • Number of events 2 • Up to five years
|
|
Psychiatric disorders
Psychotic disorder
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Psychiatric disorders
Suicidal ideation
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Renal and urinary disorders
Urinary retention
|
1.5%
6/395 • Number of events 7 • Up to five years
|
|
Renal and urinary disorders
Haematuria
|
0.76%
3/395 • Number of events 3 • Up to five years
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Renal and urinary disorders
Bladder disorder
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Renal and urinary disorders
Renal colic
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.76%
3/395 • Number of events 3 • Up to five years
|
|
Reproductive system and breast disorders
Cystocele
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Reproductive system and breast disorders
Prostatism
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.51%
2/395 • Number of events 4 • Up to five years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.76%
3/395 • Number of events 3 • Up to five years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Surgical and medical procedures
Deep brain stimulation
|
0.76%
3/395 • Number of events 3 • Up to five years
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.76%
3/395 • Number of events 3 • Up to five years
|
|
Surgical and medical procedures
Drug therapy changed
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Surgical and medical procedures
Rehabilitation therapy
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Surgical and medical procedures
Cataract operation
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Surgical and medical procedures
Spinal operation
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Surgical and medical procedures
Open reduction of fracture
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Vascular disorders
Deep vein thrombosis
|
0.76%
3/395 • Number of events 3 • Up to five years
|
|
Vascular disorders
Thrombophlebitis
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Vascular disorders
Orthostatic hypotension
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Vascular disorders
Cardiovascular insufficiency
|
0.25%
1/395 • Number of events 2 • Up to five years
|
|
Vascular disorders
Haematoma
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Vascular disorders
Hypertension
|
0.25%
1/395 • Number of events 1 • Up to five years
|
|
Vascular disorders
Circulatory collapse
|
0.25%
1/395 • Number of events 2 • Up to five years
|
|
Vascular disorders
Aortic aneurysm
|
0.25%
1/395 • Number of events 1 • Up to five years
|
Other adverse events
| Measure |
Rotigotine
n=395 participants at risk
Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
13.7%
54/395 • Number of events 62 • Up to five years
|
|
Gastrointestinal disorders
Constipation
|
6.6%
26/395 • Number of events 29 • Up to five years
|
|
General disorders
Application site erythema
|
10.1%
40/395 • Number of events 45 • Up to five years
|
|
General disorders
Application site pruritus
|
9.6%
38/395 • Number of events 39 • Up to five years
|
|
General disorders
Application site reaction
|
7.3%
29/395 • Number of events 32 • Up to five years
|
|
General disorders
Oedema peripheral
|
8.4%
33/395 • Number of events 35 • Up to five years
|
|
Infections and infestations
Urinary tract infection
|
6.8%
27/395 • Number of events 46 • Up to five years
|
|
Injury, poisoning and procedural complications
Fall
|
15.4%
61/395 • Number of events 117 • Up to five years
|
|
Investigations
Weight decreased
|
10.9%
43/395 • Number of events 52 • Up to five years
|
|
Investigations
Weight increased
|
7.6%
30/395 • Number of events 32 • Up to five years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.2%
48/395 • Number of events 57 • Up to five years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.1%
32/395 • Number of events 36 • Up to five years
|
|
Nervous system disorders
Somnolence
|
33.7%
133/395 • Number of events 170 • Up to five years
|
|
Nervous system disorders
Dyskinesia
|
13.9%
55/395 • Number of events 74 • Up to five years
|
|
Nervous system disorders
Parkinson's disease
|
11.1%
44/395 • Number of events 52 • Up to five years
|
|
Nervous system disorders
Dizziness
|
6.8%
27/395 • Number of events 31 • Up to five years
|
|
Nervous system disorders
Headache
|
6.8%
27/395 • Number of events 33 • Up to five years
|
|
Psychiatric disorders
Hallucination
|
8.1%
32/395 • Number of events 35 • Up to five years
|
|
Psychiatric disorders
Hallucination, visual
|
5.1%
20/395 • Number of events 27 • Up to five years
|
|
Psychiatric disorders
Insomnia
|
11.4%
45/395 • Number of events 52 • Up to five years
|
|
Psychiatric disorders
Depression
|
7.8%
31/395 • Number of events 33 • Up to five years
|
|
Psychiatric disorders
Abnormal dreams
|
5.1%
20/395 • Number of events 23 • Up to five years
|
|
Vascular disorders
Orthostatic hypotension
|
5.1%
20/395 • Number of events 21 • Up to five years
|
|
Vascular disorders
Hypertension
|
6.1%
24/395 • Number of events 26 • Up to five years
|
Additional Information
UCB Clinical Trial Call Center
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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