Trial Outcomes & Findings for Transdermal Rotigotine User Surveillance Study (NCT NCT00599339)

Last Updated: 2018-08-09

Results Overview

The Unified Parkinson's disease rating scale (UPDRS) Part III (Motor Examination) contains 31 questions. Each question ranges from 0 (best possible outcome) to 4 (worst outcome). The total score ranges from 0 (best possible outcome) to 124 (worst outcome).

Recruitment status

COMPLETED

Target enrollment

2195 participants

Primary outcome timeframe

From Baseline to Visit 7 (Month 33)

Results posted on

2018-08-09

Participant Flow

The study started to enroll subjects in June 2006. Overall, 2195 patients were enrolled in this study (Enrolled Set \[ES\]), of which 2179 were treated with rotigotine or another Parkinson's disease treatment according to the study protocol at least once (Safety Set \[SS\]).

There were 36 patients without valid data consent. Therefore only Safety data were analyzed for these 36 patients. Patients without valid data consent or an unknown study termination status were neither considered as completer nor as non-completer in the Clinical Study Report. These patients are considered as non-completers in the summary below.

Participant milestones

Participant milestones
Measure	Overall For this study, 5 groups of patients with different Parkinson's disease treatments were to be considered. Initial treatments were to include dopaminergic monotherapy with rotigotine, other dopamine agonists (eg, pramipexole, cabergoline, ropinirole), or L-dopa, treatment with L-dopa combined with rotigotine or other dopamine agonists. Treatment was to be performed according to standard medical practice. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Overall Study STARTED	2195
Overall Study Safety Set	2179
Overall Study COMPLETED	1531
Overall Study NOT COMPLETED	664

Reasons for withdrawal

Reasons for withdrawal
Measure	Overall For this study, 5 groups of patients with different Parkinson's disease treatments were to be considered. Initial treatments were to include dopaminergic monotherapy with rotigotine, other dopamine agonists (eg, pramipexole, cabergoline, ropinirole), or L-dopa, treatment with L-dopa combined with rotigotine or other dopamine agonists. Treatment was to be performed according to standard medical practice. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Overall Study Adverse Event	79
Overall Study Withdrawal by Subject	137
Overall Study Other Reason	179
Overall Study Lost to Follow-up	221
Overall Study No valid data consent	36
Overall Study Study Termination Status Unknown	12

Baseline Characteristics

Transdermal Rotigotine User Surveillance Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=2159 Participants For this study, 5 groups of patients with different Parkinson's disease treatments were to be considered. Initial treatments were to include dopaminergic monotherapy with rotigotine, other dopamine agonists (eg, pramipexole, cabergoline, ropinirole), or L-dopa, treatment with L-dopa combined with rotigotine or other dopamine agonists. Treatment was to be performed according to standard medical practice. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	724 Participants n=5 Participants
Age, Categorical >=65 years	1435 Participants n=5 Participants
Age, Continuous	67.7 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	956 Participants n=5 Participants
Sex: Female, Male Male	1203 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline to Visit 7 (Month 33)

Population: All enrolled and treated patients, having at least one valid on-treatment measurement in any efficacy variable are included in the Full Analysis Set (FAS). Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.

Outcome measures

Outcome measures
Measure	Neupro Monotherapy (>= 3 Months) n=203 Participants This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline.	Neupro Monotherapy (< 3 Months) n=11 Participants This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline.	Other Dopamine Agonist (>= 3 Months) n=145 Participants This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline.	Other Dopamine Agonist (< 3 Months) n=10 Participants This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline.	L-Dopa Monotherapy (>= 3 Months) n=233 Participants This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline.	L-Dopa Monotherapy (< 3 Months) n=23 Participants This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline.	Multiple Dopamine Agonists (>= 3 Months) n=13 Participants This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline.	Multiple Dopamine Agonists (< 3 Months) n=2 Participants This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline.	Neupro + L-Dopa (>= 3 Months) n=400 Participants This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline.	Neupro + L-Dopa (< 3 Months) n=6 Participants This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline.	Other Dopamine Agonist + L-Dopa (>= 3 Months) n=377 Participants This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline.	Other Dopamine Agonist + L-Dopa (< 3 Months) n=11 Participants This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline.	Multiple Dopamine Agonists + L-Dopa (>= 3 Months) n=35 Participants This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline.	Multiple Dopamine Agonists + L-Dopa (< 3 Months) n=2 Participants This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline.	Not Treated (>= 3 Months) n=13 Participants This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily not treated at Baseline.	Not Treated (< 3 Months) n=36 Participants This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily not treated at Baseline.
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33)	-2.5 units on a scale Standard Deviation 14.7	-2.5 units on a scale Standard Deviation 10.3	-2.2 units on a scale Standard Deviation 11.1	-5.6 units on a scale Standard Deviation 16.9	0.2 units on a scale Standard Deviation 13.2	0.0 units on a scale Standard Deviation 12.2	-1.2 units on a scale Standard Deviation 13.8	3.5 units on a scale Standard Deviation 6.4	-1.2 units on a scale Standard Deviation 14.2	-1.5 units on a scale Standard Deviation 17.5	-2.5 units on a scale Standard Deviation 13.9	8.6 units on a scale Standard Deviation 13.5	1.5 units on a scale Standard Deviation 14.7	20.0 units on a scale Standard Deviation 29.7	-3.2 units on a scale Standard Deviation 10.8	4.1 units on a scale Standard Deviation 15.0

SECONDARY outcome

Timeframe: From Baseline to Visit 7 (Month 33)

The Unified Parkinson's disease rating scale (UPDRS) question 32 of part IV asks. "What Proportion of the waking day are dyskinesias present?" Answers range from 0 (None) to 4 (76-100 % of the day).

Outcome measures

Outcome measures
Measure	Neupro Monotherapy (>= 3 Months) n=204 Participants This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline.	Neupro Monotherapy (< 3 Months) n=11 Participants This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline.	Other Dopamine Agonist (>= 3 Months) n=145 Participants This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline.	Other Dopamine Agonist (< 3 Months) n=10 Participants This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline.	L-Dopa Monotherapy (>= 3 Months) n=233 Participants This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline.	L-Dopa Monotherapy (< 3 Months) n=23 Participants This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline.	Multiple Dopamine Agonists (>= 3 Months) n=13 Participants This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline.	Multiple Dopamine Agonists (< 3 Months) n=2 Participants This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline.	Neupro + L-Dopa (>= 3 Months) n=400 Participants This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline.	Neupro + L-Dopa (< 3 Months) n=6 Participants This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline.	Other Dopamine Agonist + L-Dopa (>= 3 Months) n=377 Participants This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline.	Other Dopamine Agonist + L-Dopa (< 3 Months) n=11 Participants This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline.	Multiple Dopamine Agonists + L-Dopa (>= 3 Months) n=35 Participants This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline.	Multiple Dopamine Agonists + L-Dopa (< 3 Months) n=2 Participants This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline.	Not Treated (>= 3 Months) n=13 Participants This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily not treated at Baseline.	Not Treated (< 3 Months) n=37 Participants This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily not treated at Baseline.
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33)	-0.1 units on a scale Standard Deviation 0.7	-0.2 units on a scale Standard Deviation 0.6	-0.1 units on a scale Standard Deviation 0.5	0.0 units on a scale Standard Deviation 0.8	0.1 units on a scale Standard Deviation 0.8	-0.1 units on a scale Standard Deviation 0.5	-0.1 units on a scale Standard Deviation 0.5	0.0 units on a scale Standard Deviation 0.0	0.1 units on a scale Standard Deviation 0.7	0.2 units on a scale Standard Deviation 1.0	0.2 units on a scale Standard Deviation 0.7	0.2 units on a scale Standard Deviation 0.6	0.2 units on a scale Standard Deviation 0.7	0.5 units on a scale Standard Deviation 0.7	-0.2 units on a scale Standard Deviation 0.4	0.1 units on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: From Baseline to Visit 7 (Month 33)

The Unified Parkinson's disease rating scale (UPDRS) Part IV question 33 asks for complications of therapy in the past week, through the question "How disabling are the dyskinesias ? " Answers range from 0 (Not disabling) to 4 (Completely disabling).

Outcome measures

Outcome measures
Measure	Neupro Monotherapy (>= 3 Months) n=204 Participants This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline.	Neupro Monotherapy (< 3 Months) n=11 Participants This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline.	Other Dopamine Agonist (>= 3 Months) n=145 Participants This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline.	Other Dopamine Agonist (< 3 Months) n=10 Participants This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline.	L-Dopa Monotherapy (>= 3 Months) n=233 Participants This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline.	L-Dopa Monotherapy (< 3 Months) n=23 Participants This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline.	Multiple Dopamine Agonists (>= 3 Months) n=13 Participants This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline.	Multiple Dopamine Agonists (< 3 Months) n=2 Participants This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline.	Neupro + L-Dopa (>= 3 Months) n=400 Participants This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline.	Neupro + L-Dopa (< 3 Months) n=6 Participants This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline.	Other Dopamine Agonist + L-Dopa (>= 3 Months) n=377 Participants This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline.	Other Dopamine Agonist + L-Dopa (< 3 Months) n=11 Participants This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline.	Multiple Dopamine Agonists + L-Dopa (>= 3 Months) n=35 Participants This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline.	Multiple Dopamine Agonists + L-Dopa (< 3 Months) n=2 Participants This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline.	Not Treated (>= 3 Months) n=13 Participants This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily not treated at Baseline.	Not Treated (< 3 Months) n=37 Participants This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily not treated at Baseline.
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33)	-0.1 units on a scale Standard Deviation 0.7	-0.2 units on a scale Standard Deviation 0.4	-0.1 units on a scale Standard Deviation 0.4	-0.1 units on a scale Standard Deviation 0.7	0.0 units on a scale Standard Deviation 0.8	-0.0 units on a scale Standard Deviation 0.7	-0.1 units on a scale Standard Deviation 0.6	0.0 units on a scale Standard Deviation 0.0	0.0 units on a scale Standard Deviation 0.7	0.0 units on a scale Standard Deviation 0.6	0.1 units on a scale Standard Deviation 0.7	-0.1 units on a scale Standard Deviation 0.7	0.2 units on a scale Standard Deviation 0.8	0.0 units on a scale Standard Deviation 0.0	-0.1 units on a scale Standard Deviation 0.3	0.2 units on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: 33 months

The Unified Parkinson's disease rating scale (UPDRS) Part IV question 39 asks "What proportion of the waking day is the patient "off", on average?" Answers range from 0 (None) to 4 (76-100 % of the day).

Outcome measures

Outcome measures
Measure	Neupro Monotherapy (>= 3 Months) n=204 Participants This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline.	Neupro Monotherapy (< 3 Months) n=11 Participants This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline.	Other Dopamine Agonist (>= 3 Months) n=145 Participants This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline.	Other Dopamine Agonist (< 3 Months) n=10 Participants This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline.	L-Dopa Monotherapy (>= 3 Months) n=233 Participants This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline.	L-Dopa Monotherapy (< 3 Months) n=23 Participants This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline.	Multiple Dopamine Agonists (>= 3 Months) n=13 Participants This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline.	Multiple Dopamine Agonists (< 3 Months) n=2 Participants This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline.	Neupro + L-Dopa (>= 3 Months) n=400 Participants This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline.	Neupro + L-Dopa (< 3 Months) n=6 Participants This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline.	Other Dopamine Agonist + L-Dopa (>= 3 Months) n=377 Participants This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline.	Other Dopamine Agonist + L-Dopa (< 3 Months) n=11 Participants This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline.	Multiple Dopamine Agonists + L-Dopa (>= 3 Months) n=35 Participants This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline.	Multiple Dopamine Agonists + L-Dopa (< 3 Months) n=2 Participants This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline.	Not Treated (>= 3 Months) n=13 Participants This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily not treated at Baseline.	Not Treated (< 3 Months) n=37 Participants This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily not treated at Baseline.
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33)	-0.2 units on a scale Standard Deviation 0.9	0.5 units on a scale Standard Deviation 0.9	-0.1 units on a scale Standard Deviation 0.8	0.1 units on a scale Standard Deviation 0.9	0.1 units on a scale Standard Deviation 0.9	0.1 units on a scale Standard Deviation 1.1	-0.4 units on a scale Standard Deviation 0.9	0.0 units on a scale Standard Deviation 0.0	0.0 units on a scale Standard Deviation 0.8	0.0 units on a scale Standard Deviation 0.0	0.2 units on a scale Standard Deviation 0.9	0.2 units on a scale Standard Deviation 0.9	-0.0 units on a scale Standard Deviation 1.0	1.5 units on a scale Standard Deviation 2.1	0.0 units on a scale Standard Deviation 0.4	0.3 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 33 months

The NADCS assesses sleep-related motor complaints including nocturnal akinesia, dystonia and painful cramps by an ordinal severity scale. The NADCS total score ranges from 0 (normal) to 4 (maximum severity). NADCS value was missing for one subject at Visit 7.

Outcome measures

Outcome measures
Measure	Neupro Monotherapy (>= 3 Months) n=204 Participants This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline.	Neupro Monotherapy (< 3 Months) n=11 Participants This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline.	Other Dopamine Agonist (>= 3 Months) n=145 Participants This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline.	Other Dopamine Agonist (< 3 Months) n=10 Participants This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline.	L-Dopa Monotherapy (>= 3 Months) n=232 Participants This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline.	L-Dopa Monotherapy (< 3 Months) n=23 Participants This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline.	Multiple Dopamine Agonists (>= 3 Months) n=13 Participants This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline.	Multiple Dopamine Agonists (< 3 Months) n=2 Participants This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline.	Neupro + L-Dopa (>= 3 Months) n=400 Participants This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline.	Neupro + L-Dopa (< 3 Months) n=6 Participants This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline.	Other Dopamine Agonist + L-Dopa (>= 3 Months) n=376 Participants This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline.	Other Dopamine Agonist + L-Dopa (< 3 Months) n=11 Participants This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline.	Multiple Dopamine Agonists + L-Dopa (>= 3 Months) n=34 Participants This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline.	Multiple Dopamine Agonists + L-Dopa (< 3 Months) n=2 Participants This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline.	Not Treated (>= 3 Months) n=13 Participants This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily not treated at Baseline.	Not Treated (< 3 Months) n=37 Participants This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily not treated at Baseline.
Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33)	-0.27 units on a scale Standard Deviation 1.79	1.36 units on a scale Standard Deviation 3.51	-0.15 units on a scale Standard Deviation 1.48	0.05 units on a scale Standard Deviation 2.53	-0.09 units on a scale Standard Deviation 1.84	-0.26 units on a scale Standard Deviation 2.30	-0.73 units on a scale Standard Deviation 1.49	0.75 units on a scale Standard Deviation 1.06	-0.03 units on a scale Standard Deviation 2.06	-0.42 units on a scale Standard Deviation 2.01	-0.03 units on a scale Standard Deviation 2.07	1.05 units on a scale Standard Deviation 1.39	-0.01 units on a scale Standard Deviation 1.90	3.25 units on a scale Standard Deviation 4.60	-0.38 units on a scale Standard Deviation 1.10	0.22 units on a scale Standard Deviation 2.19

SECONDARY outcome

Timeframe: 33 months

The Hoehn and Yahr staging of Parkinson's disease in the "on" stage, if applicable, had to be completed by the physician. Possible staging: * 0 No signs of disease * 1 Unilateral disease * 2 Bilateral disease without impairment of balance * 3 Mild to moderate bilateral disease, some postural instability, physically dependent * 4 Severe disability, still able to walk or stand unassisted * 5 Wheelchair bound or bedridden unless aided

Outcome measures

Outcome measures
Measure	Neupro Monotherapy (>= 3 Months) n=207 Participants This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline.	Neupro Monotherapy (< 3 Months) n=11 Participants This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline.	Other Dopamine Agonist (>= 3 Months) n=146 Participants This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline.	Other Dopamine Agonist (< 3 Months) n=11 Participants This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline.	L-Dopa Monotherapy (>= 3 Months) n=234 Participants This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline.	L-Dopa Monotherapy (< 3 Months) n=23 Participants This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline.	Multiple Dopamine Agonists (>= 3 Months) n=13 Participants This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline.	Multiple Dopamine Agonists (< 3 Months) n=2 Participants This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline.	Neupro + L-Dopa (>= 3 Months) n=401 Participants This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline.	Neupro + L-Dopa (< 3 Months) n=6 Participants This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline.	Other Dopamine Agonist + L-Dopa (>= 3 Months) n=378 Participants This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline.	Other Dopamine Agonist + L-Dopa (< 3 Months) n=11 Participants This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline.	Multiple Dopamine Agonists + L-Dopa (>= 3 Months) n=36 Participants This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline.	Multiple Dopamine Agonists + L-Dopa (< 3 Months) n=2 Participants This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline.	Not Treated (>= 3 Months) n=13 Participants This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily not treated at Baseline.	Not Treated (< 3 Months) n=37 Participants This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily not treated at Baseline.
Hoehn & Yahr Stage at Visit 7 (Month 33) 0	2 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	2 participants	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Hoehn & Yahr Stage at Visit 7 (Month 33) 1	55 participants	1 participants	48 participants	0 participants	29 participants	1 participants	0 participants	1 participants	29 participants	2 participants	37 participants	0 participants	2 participants	0 participants	4 participants	3 participants
Hoehn & Yahr Stage at Visit 7 (Month 33) 2	112 participants	4 participants	76 participants	6 participants	118 participants	12 participants	7 participants	1 participants	186 participants	2 participants	192 participants	2 participants	15 participants	1 participants	7 participants	19 participants
Hoehn & Yahr Stage at Visit 7 (Month 33) 3	28 participants	4 participants	19 participants	4 participants	70 participants	8 participants	5 participants	0 participants	131 participants	2 participants	119 participants	4 participants	13 participants	0 participants	1 participants	11 participants
Hoehn & Yahr Stage at Visit 7 (Month 33) 4	8 participants	2 participants	2 participants	0 participants	14 participants	2 participants	1 participants	0 participants	46 participants	0 participants	24 participants	4 participants	3 participants	1 participants	1 participants	3 participants
Hoehn & Yahr Stage at Visit 7 (Month 33) 5	1 participants	0 participants	0 participants	0 participants	3 participants	0 participants	0 participants	0 participants	6 participants	0 participants	4 participants	1 participants	2 participants	0 participants	0 participants	1 participants
Hoehn & Yahr Stage at Visit 7 (Month 33) No Data/Missing	1 participants	0 participants	1 participants	1 participants	0 participants	0 participants	0 participants	0 participants	1 participants	0 participants	1 participants	0 participants	1 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: 33 months

Population: For analysis of Safety the patients in the Safety Set were sub-grouped into patients at risk developing an Adverse Event (AE) associated with rotigotine and patients at risk developing an AE not associated with rotigotine. This sub-grouping is non-disjunctive in nature, i.e. one patient might fall into both subgroups.

The analysis was performed for the non-disjunctive classification into patients at risk to develop an Adverse Event associated with Rotigotine and patients at risk to develop an Adverse Event not associated with Rotigotine.

Outcome measures

Outcome measures
Measure	Neupro Monotherapy (>= 3 Months) n=1390 Participants This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline.	Neupro Monotherapy (< 3 Months) n=1328 Participants This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline.	Other Dopamine Agonist (>= 3 Months) This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline.	Other Dopamine Agonist (< 3 Months) This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline.	L-Dopa Monotherapy (>= 3 Months) This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline.	L-Dopa Monotherapy (< 3 Months) This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline.	Multiple Dopamine Agonists (>= 3 Months) This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline.	Multiple Dopamine Agonists (< 3 Months) This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline.	Neupro + L-Dopa (>= 3 Months) This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline.	Neupro + L-Dopa (< 3 Months) This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline.	Other Dopamine Agonist + L-Dopa (>= 3 Months) This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline.	Other Dopamine Agonist + L-Dopa (< 3 Months) This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline.	Multiple Dopamine Agonists + L-Dopa (>= 3 Months) This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline.	Multiple Dopamine Agonists + L-Dopa (< 3 Months) This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline.	Not Treated (>= 3 Months) This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily not treated at Baseline.	Not Treated (< 3 Months) This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study. Thus, subjects presented in this group weren't necessarily not treated at Baseline.
Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 33 Months) Cardiac valve disease	1 Adverse Events	1 Adverse Events	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 33 Months) Cardiac valve sclerosis	0 Adverse Events	2 Adverse Events	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 33 Months) Aortic valve sclerosis	1 Adverse Events	0 Adverse Events	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Adverse Events

Associated With Rotigotine

Serious events: 261 serious events

Other events: 237 other events

Deaths: 0 deaths

Not Associated With Rotigotine

Serious events: 269 serious events

Other events: 245 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Associated With Rotigotine n=1390 participants at risk A patient was analyzed related to Adverse Events (AEs) associated with Rotigotine only if during the study he was at risk to develop an AE associated with Rotigotine. An Adverse Event was considered to be associated with Rotigotine if Rotigotine was administered at least once within 30 days prior to the onset of the adverse event. "Associated Event" does not necessarily mean related to treatment with Rotigotine.	Not Associated With Rotigotine n=1328 participants at risk A patient was analyzed related to Adverse Events (AEs) not associated with Rotigotine only if during the study he was at risk to develop an AE not associated with Rotigotine. An adverse event was considered not to be associated with Rotigotine, if no Rotigotine was administered in the 30 days period prior to the onset of the AE.
Gastrointestinal disorders Nausea	7.6% 105/1390 • Number of events 120 • Adverse Events (AEs) were collected during the course of the study from Baseline (Visit 1) up to Visit 7 (Month 33 ± 30 days). For analysis of Safety the patients in the Safety Set were sub-grouped into patients at risk developing an Adverse Event (AE) associated with rotigotine and patients at risk developing an AE not associated with rotigotine. This sub-grouping is non-disjunctive in nature, i.e. one patient might fall into both subgroups.	6.4% 85/1328 • Number of events 101 • Adverse Events (AEs) were collected during the course of the study from Baseline (Visit 1) up to Visit 7 (Month 33 ± 30 days). For analysis of Safety the patients in the Safety Set were sub-grouped into patients at risk developing an Adverse Event (AE) associated with rotigotine and patients at risk developing an AE not associated with rotigotine. This sub-grouping is non-disjunctive in nature, i.e. one patient might fall into both subgroups.
General disorders Fatigue	4.8% 67/1390 • Number of events 76 • Adverse Events (AEs) were collected during the course of the study from Baseline (Visit 1) up to Visit 7 (Month 33 ± 30 days). For analysis of Safety the patients in the Safety Set were sub-grouped into patients at risk developing an Adverse Event (AE) associated with rotigotine and patients at risk developing an AE not associated with rotigotine. This sub-grouping is non-disjunctive in nature, i.e. one patient might fall into both subgroups.	5.8% 77/1328 • Number of events 82 • Adverse Events (AEs) were collected during the course of the study from Baseline (Visit 1) up to Visit 7 (Month 33 ± 30 days). For analysis of Safety the patients in the Safety Set were sub-grouped into patients at risk developing an Adverse Event (AE) associated with rotigotine and patients at risk developing an AE not associated with rotigotine. This sub-grouping is non-disjunctive in nature, i.e. one patient might fall into both subgroups.
Injury, poisoning and procedural complications Fall	3.5% 49/1390 • Number of events 60 • Adverse Events (AEs) were collected during the course of the study from Baseline (Visit 1) up to Visit 7 (Month 33 ± 30 days). For analysis of Safety the patients in the Safety Set were sub-grouped into patients at risk developing an Adverse Event (AE) associated with rotigotine and patients at risk developing an AE not associated with rotigotine. This sub-grouping is non-disjunctive in nature, i.e. one patient might fall into both subgroups.	5.0% 67/1328 • Number of events 79 • Adverse Events (AEs) were collected during the course of the study from Baseline (Visit 1) up to Visit 7 (Month 33 ± 30 days). For analysis of Safety the patients in the Safety Set were sub-grouped into patients at risk developing an Adverse Event (AE) associated with rotigotine and patients at risk developing an AE not associated with rotigotine. This sub-grouping is non-disjunctive in nature, i.e. one patient might fall into both subgroups.
Psychiatric disorders Depression	3.9% 54/1390 • Number of events 55 • Adverse Events (AEs) were collected during the course of the study from Baseline (Visit 1) up to Visit 7 (Month 33 ± 30 days). For analysis of Safety the patients in the Safety Set were sub-grouped into patients at risk developing an Adverse Event (AE) associated with rotigotine and patients at risk developing an AE not associated with rotigotine. This sub-grouping is non-disjunctive in nature, i.e. one patient might fall into both subgroups.	5.4% 72/1328 • Number of events 74 • Adverse Events (AEs) were collected during the course of the study from Baseline (Visit 1) up to Visit 7 (Month 33 ± 30 days). For analysis of Safety the patients in the Safety Set were sub-grouped into patients at risk developing an Adverse Event (AE) associated with rotigotine and patients at risk developing an AE not associated with rotigotine. This sub-grouping is non-disjunctive in nature, i.e. one patient might fall into both subgroups.

Additional Information

UCB Clinical Trial Call Center

UCB

Phone: +1 877 822 9493 (UCB)

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60