Trial Outcomes & Findings for Long-term Open-label Trial in Idiopathic Restless Legs Syndrome (RLS) (NCT NCT00498186)
NCT ID: NCT00498186
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
PHASE2
Target enrollment
295 participants
Primary outcome timeframe
Up to five years
Results posted on
2014-10-02
Participant Flow
A total of 295 subjects belong to the Enrolled Set (ES) and all of them received at least one dose of trial medication, so they all belong to the Safety Set (SS).
Participant Flow information and Baseline Characteristics belong to the Safety Set (SS).
Participant milestones
| Measure |
Rotigotine
Rotigotine trans-dermal patch
|
|---|---|
|
Overall Study
STARTED
|
295
|
|
Overall Study
COMPLETED
|
122
|
|
Overall Study
NOT COMPLETED
|
173
|
Reasons for withdrawal
| Measure |
Rotigotine
Rotigotine trans-dermal patch
|
|---|---|
|
Overall Study
Protocol Violation
|
10
|
|
Overall Study
Lack of Efficacy
|
31
|
|
Overall Study
Adverse Event
|
89
|
|
Overall Study
Unsatisfactory compliance of subject
|
12
|
|
Overall Study
Withdrawal by Subject
|
18
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Other
|
10
|
Baseline Characteristics
Long-term Open-label Trial in Idiopathic Restless Legs Syndrome (RLS)
Baseline characteristics by cohort
| Measure |
Rotigotine
n=295 Participants
Rotigotine trans-dermal patch
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
208 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
87 Participants
n=5 Participants
|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
196 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
26.37 kg/ m^2
STANDARD_DEVIATION 3.84 • n=5 Participants
|
|
Height
|
167.5 cm
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Weight
|
74.21 kilogram (kg)
STANDARD_DEVIATION 13.19 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to five yearsPopulation: Of the 295 subjects who entered the study, 295 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=295 Participants
Rotigotine trans-dermal patch
|
|---|---|
|
Number of Subjects With at Least One Adverse Event, as Reported Spontaneously by the Subject or Observed by the Investigator, During the 5-year Open-label Extension.
|
273 participants
|
SECONDARY outcome
Timeframe: Up to five yearsPopulation: Of the 295 subjects who entered the study, 295 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=295 Participants
Rotigotine trans-dermal patch
|
|---|---|
|
Number of Subjects Who Withdrew From the Trial Due to an Adverse Event During the 5-year Open Label Extension
|
93 participants
|
Adverse Events
Rotigotine
Serious events: 79 serious events
Other events: 272 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rotigotine
n=295 participants at risk
Rotigotine trans-dermal patch
|
|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Cardiac disorders
Coronary artery disease
|
0.68%
2/295 • Number of events 2 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Cardiac disorders
Cardiac failure
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Cardiac disorders
Myocardial infarction
|
1.4%
4/295 • Number of events 5 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Cardiac disorders
Angina pectoris
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Cardiac disorders
Bradycardia
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Cardiac disorders
Tachycardia
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Endocrine disorders
Goitre
|
0.68%
2/295 • Number of events 2 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Eye disorders
Diplopia
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Nausea
|
0.68%
2/295 • Number of events 2 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Gastrointestinal disorders
Haematochezia
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
General disorders
Fatigue
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
General disorders
Hernia
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
General disorders
Inflammation
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
General disorders
Cyst
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
General disorders
Necrosis
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
General disorders
Oedema peripheral
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Infections and infestations
Appendicitis
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Infections and infestations
Gastroenteritis
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Infections and infestations
Perianal abscess
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Infections and infestations
Pneumonia
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Infections and infestations
Pyelonephritis
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Infections and infestations
Pyelonephritis chronic
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
1.0%
3/295 • Number of events 3 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Investigations
Blood pressure increased
|
0.34%
1/295 • Number of events 2 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Toe deformity
|
1.4%
4/295 • Number of events 4 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Impingement syndrome
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
3.7%
11/295 • Number of events 13 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Lumbal spinal stenosis
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland adenoma
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
1.0%
3/295 • Number of events 3 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Nervous system disorders
Polyneuropathy
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Nervous system disorders
Cerebellar infarction
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Nervous system disorders
Syncope
|
1.0%
3/295 • Number of events 3 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Nervous system disorders
Tension headache
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Nervous system disorders
Migraine
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Nervous system disorders
Presyncope
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Nervous system disorders
Restless legs syndrome
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Renal and urinary disorders
Bladder prolapse
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoe syndrome
|
0.68%
2/295 • Number of events 2 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Surgical and medical procedures
Abdominoplasty
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Surgical and medical procedures
Bladder operation
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.68%
2/295 • Number of events 2 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Surgical and medical procedures
Limb operation
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Surgical and medical procedures
Hysterectomy
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Surgical and medical procedures
Angioplasty
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Vascular disorders
Arterial occlusive disease
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Vascular disorders
Arteriosclerosis
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Vascular disorders
Vascular occlusion
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Vascular disorders
Deep vein thrombosis
|
0.34%
1/295 • Number of events 1 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Vascular disorders
Varicose vein
|
1.0%
3/295 • Number of events 3 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
Other adverse events
| Measure |
Rotigotine
n=295 participants at risk
Rotigotine trans-dermal patch
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
11.9%
35/295 • Number of events 44 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
General disorders
Application site erythema
|
32.5%
96/295 • Number of events 132 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
General disorders
Application site reaction
|
25.1%
74/295 • Number of events 90 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
General disorders
Application site pruritus
|
18.3%
54/295 • Number of events 71 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
General disorders
Fatigue
|
10.5%
31/295 • Number of events 36 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Infections and infestations
Influenza
|
5.1%
15/295 • Number of events 17 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Infections and infestations
Bronchitis
|
6.8%
20/295 • Number of events 26 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Infections and infestations
Nasopharyngitis
|
18.6%
55/295 • Number of events 78 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
21/295 • Number of events 25 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.6%
40/295 • Number of events 50 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
6.4%
19/295 • Number of events 19 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Nervous system disorders
Headache
|
5.4%
16/295 • Number of events 21 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Nervous system disorders
Dizziness
|
5.4%
16/295 • Number of events 20 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Psychiatric disorders
Depression
|
7.5%
22/295 • Number of events 25 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Psychiatric disorders
Insomnia
|
5.8%
17/295 • Number of events 18 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Psychiatric disorders
Sleep disorder
|
7.1%
21/295 • Number of events 22 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Erythemas
|
5.8%
17/295 • Number of events 17 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.1%
15/295 • Number of events 16 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
|
Vascular disorders
Hypertension
|
8.8%
26/295 • Number of events 28 • Adverse Events (AEs) were collected over the whole trial period up to 5 years from Visit 1 to the Safety Follow- up Visit.
Serious and non- serious Adverse Events (AEs) refer to the Safety Set (SS). The SS includes all subjects who received at least one dose of trial medication.
|
Additional Information
UCB Clinical Trial Call Center
UCB
Phone: +1 877 822 9493 (UCB)
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