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TRUST: Transdermal Rotigotine User Surveillance Study

Sponsor
UCB Pharma (Industry)
Overall Status
Completed
CT.gov ID
NCT00599339
Collaborator
(none)
2,195
Enrollment
211
Locations
94
Duration (Months)
10.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will be conducted in an observational multiple-cohort design aimed at acquiring clinical, treatment, health status, and economic data. Patients with Parkinson's disease (PD) will be enrolled.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    All patients attending the physician and fulfilling the eligibility criteria are included.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    2195 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Naturalistic, Multisite, Observational Study of Rotigotine Transdermal Patch and Other Currently Prescribed Therapies in Patients With Idiopathic Parkinson's Disease
    Study Start Date :
    Jun 1, 2006
    Actual Primary Completion Date :
    Apr 1, 2014
    Actual Study Completion Date :
    Apr 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    Neupro

    Neupro at study onset
    Dopamine Agonist

    Other Dopamine-Agonist at study onset
    L-Dopa

    L-Dopa
    Neupro + L-Dopa

    Neupro in combination with L-Dopa at study onset
    Dopamine Agonist + L-Dopa

    Other Dopamine Agonist in combination with L-Dopa at study onset

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33) [From Baseline to Visit 7 (Month 33)]

      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).

    Secondary Outcome Measures

    1. Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33) [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).

    2. Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33) [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).

    3. Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33) [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).

    4. Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33) [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.

    5. Hoehn & Yahr Stage at Visit 7 (Month 33) [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

    6. Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 33 Months) [33 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with idiopathic early-stage Parkinson's Disease requiring dopaminergic monotherapy (rotigotine, other dopamine agonists or levodopa) at study onset

    • Patients with advanced-stage Parkinson's Disease requiring dopaminergic therapy with levodopa in combination with rotigotine or other dopamine agonists at study onset

    Exclusion Criteria:
    • Patients who are unable to comply with study requirements

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 813 Chomutov Czechia
    2 808 Hradec Kralove Czechia
    3 822 Hradec Kralove Czechia
    4 811 Litomysl Czechia
    5 803 Ostrava-Poruba Czechia
    6 809 Pardubice Czechia
    7 817 Pisek Czechia
    8 814 Plzen-Lochotin Czechia
    9 829 Praha 10 Czechia
    10 805 Praha 1 Czechia
    11 825 Praha 4 Czechia
    12 804 Praha 5 Czechia
    13 832 Rakovnik Czechia
    14 819 Zlin Czechia
    15 752 Aalborg Denmark
    16 751 Aarhus Denmark
    17 750 Sonderborg Denmark
    18 242 Aalen Germany
    19 143 Achim Germany
    20 240 Alzenau Germany
    21 145 Annaberg-Buchholz Germany
    22 245 Aschaffenburg Germany
    23 185 Augsburg Germany
    24 130 Bad Neustadt Germany
    25 131 Bamberg Germany
    26 103 Berg Germany
    27 102 Berlin Germany
    28 110 Berlin Germany
    29 113 Berlin Germany
    30 119 Berlin Germany
    31 142 Berlin Germany
    32 150 Berlin Germany
    33 157 Berlin Germany
    34 163 Berlin Germany
    35 166 Berlin Germany
    36 195 Berlin Germany
    37 198 Berlin Germany
    38 206 Berlin Germany
    39 207 Berlin Germany
    40 224 Berlin Germany
    41 243 Berlin Germany
    42 108 Bielefeld Germany
    43 127 Bielefield Germany
    44 178 Blankenburg (Harz) Germany
    45 149 Bochum Germany
    46 151 Bochum Germany
    47 216 Bochum Germany
    48 220 Brandenburg Germany
    49 236 Butzbach Germany
    50 237 Butzbach Germany
    51 203 Böblingen Germany
    52 133 Dresden Germany
    53 199 Dresden Germany
    54 232 Dresden Germany
    55 219 Duisburg Germany
    56 112 Düsseldorf Germany
    57 141 Düsseldorf Germany
    58 129 Emmendingen Germany
    59 162 Erbach Germany
    60 202 Flensburg Germany
    61 156 Friedberg (Hessen) Germany
    62 247 Gera Germany
    63 223 Greifswald Germany
    64 249 Hagen Germany
    65 167 Halle (Saale) Germany
    66 121 Hamburg Germany
    67 140 Hamburg Germany
    68 176 Hamburg Germany
    69 217 Hamburg Germany
    70 241 Heidenheim Germany
    71 138 Hemmoor Germany
    72 173 Herborn Germany
    73 214 Jena Germany
    74 248 Jena Germany
    75 181 Jülich Germany
    76 105 Karlstadt Germany
    77 106 Karlstadt Germany
    78 244 Kassel Germany
    79 124 Köln Germany
    80 153 Köln Germany
    81 179 Köln Germany
    82 175 Leutkirch Germany
    83 152 Lutherstadt Eisleben Germany
    84 230 Magdeburg Germany
    85 235 Mannheim Germany
    86 148 München Germany
    87 189 München Germany
    88 191 München Germany
    89 169 Naumburg (Saale) Germany
    90 182 Neuburg Germany
    91 118 Oberhausen Germany
    92 164 Oberursel (Taunus) Germany
    93 171 Oldenburg Germany
    94 196 Oranienburg Germany
    95 114 Rheda-Wiedenbrück Germany
    96 188 Rottenburg Am Neckar Germany
    97 187 Schriesheim Germany
    98 107 Schwerin Germany
    99 134 Singen Germany
    100 229 Stadtroda Germany
    101 180 Starnberg Germany
    102 146 Stuttgart Germany
    103 186 Stuttgart Germany
    104 211 Stuttgart Germany
    105 226 Tübingen Germany
    106 139 Ulm Germany
    107 172 Unterhaching Germany
    108 239 Westerstede Germany
    109 233 Wiesbaden Germany
    110 122 Wolfach Germany
    111 194 Zwickau Germany
    112 607 Alexandroupoli Greece
    113 600 Athens Greece
    114 602 Athens Greece
    115 605 Athens Greece
    116 610 Athens Greece
    117 608 Chaidari Greece
    118 611 Marousi Greece
    119 601 Melissia Greece
    120 604 Thessaloniki Greece
    121 606 Thessaloniki Greece
    122 664 Acquaviva Delle Fonti Italy
    123 654 Ancona Italy
    124 665 Bari Italy
    125 655 Cagliari Italy
    126 666 Casarano Italy
    127 662 Cassino Italy
    128 653 Ferrara Italy
    129 661 Imperia Italy
    130 650 Lido Di Camaiore Italy
    131 663 Lodi Italy
    132 658 Messina Italy
    133 660 Napoli Italy
    134 667 Pisa Italy
    135 657 Roma Italy
    136 656 San Giovannni Rotondo Italy
    137 669 Torino Italy
    138 704 Aguascalientes Mexico
    139 707 Guadalajara Mexico
    140 703 Merida Mexico
    141 701 Mexico D.F. Mexico
    142 702 Mexico D.F. Mexico
    143 706 Monterrey Mexico
    144 710 Morelia Michoacan Mexico
    145 708 San Luis Potosi Mexico
    146 705 Zapopan Mexico
    147 425 Arad Romania
    148 406 Bacau Romania
    149 407 Bacau Romania
    150 417 Bistrita Romania
    151 412 Bucharest Romania
    152 418 Bucharest Romania
    153 423 Bucharest Romania
    154 424 Bucharest Romania
    155 434 Bucharest Romania
    156 436 Bucharest Romania
    157 427 Constanta Romania
    158 411 Craiova Romania
    159 433 Craiova Romania
    160 404 Drobeta Turnu Severin Romania
    161 437 Foscani, Jud. Vrancea Romania
    162 405 Galati Romania
    163 420 Galati Romania
    164 403 Lasi Romania
    165 409 Lasi Romania
    166 415 Medgidia Romania
    167 402 Orastie Romania
    168 401 Pitesti Romania
    169 428 Pitesti Romania
    170 422 Resista Romania
    171 435 Râmnicu Vâlcea Romania
    172 408 Satu Mare Romania
    173 429 Sfantu Gheorghe Romania
    174 413 Sibiu Romania
    175 416 Targoviste Romania
    176 414 Timisoara Romania
    177 421 Timisoara Romania
    178 432 Târgu-Mureş Romania
    179 521 Banska Bystrica Slovakia
    180 500 Bratislava Slovakia
    181 502 Bratislava Slovakia
    182 507 Bratislava Slovakia
    183 514 Bratislava Slovakia
    184 501 Dolni Kubin Slovakia
    185 505 Dubnica Nad Vahom Slovakia
    186 522 Krompachy Slovakia
    187 520 Lucenec Slovakia
    188 508 Skalica Slovakia
    189 503 Spisska Nova Ves Slovakia
    190 509 Stara Lubovna Slovakia
    191 510 Trencin Slovakia
    192 519 Vranov Slovakia
    193 516 Zilina Slovakia
    194 518 Zvolen Slovakia
    195 308 Alzira (Valencia) Spain
    196 320 Badalona Spain
    197 301 Barcelona Spain
    198 303 Barcelona Spain
    199 305 Barcelona Spain
    200 318 Barcelona Spain
    201 315 Burgos Spain
    202 313 Ciudad Real Spain
    203 306 Madrid Spain
    204 307 Madrid Spain
    205 314 Palma de Mallorca Spain
    206 312 Valencia Spain
    207 355 Biel Switzerland
    208 353 Sargans Switzerland
    209 354 St. Gallen Switzerland
    210 351 Tschugg Switzerland
    211 350 Zürich Switzerland

    Sponsors and Collaborators

    • UCB Pharma

    Investigators

    • Study Director: UCB Clinical Trial Call Center, +1 877 822 9493 (UCB)

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    UCB Pharma
    ClinicalTrials.gov Identifier:
    NCT00599339
    Other Study ID Numbers:
    • SP0854
    First Posted:
    Jan 23, 2008
    Last Update Posted:
    Aug 9, 2018
    Last Verified:
    Jul 1, 2015
    Keywords provided by UCB Pharma
    Rotigotine
    Neupro
    Additional relevant MeSH terms:
    Parkinson Disease

    Study Results

    Participant Flow

    Recruitment Details 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]).
    Pre-assignment Detail 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.
    Arm/Group Title Overall
    Arm/Group Description 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.
    Period Title: Overall Study
    STARTED 2195
    Safety Set 2179
    COMPLETED 1531
    NOT COMPLETED 664

    Baseline Characteristics

    Arm/Group Title Overall
    Arm/Group Description 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 Participants 2159
    Age (Count of Participants)
    <=18 years
    0
    0%
    Between 18 and 65 years
    724
    33.5%
    >=65 years
    1435
    66.5%
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    67.7
    (9.4)
    Sex: Female, Male (Count of Participants)
    Female
    956
    44.3%
    Male
    1203
    55.7%

    Outcome Measures

    1. Primary Outcome
    Title Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III at Visit 7 (Month 33)
    Description 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).
    Time Frame From Baseline to Visit 7 (Month 33)

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Neupro Monotherapy (>= 3 Months) Neupro Monotherapy (< 3 Months) Other Dopamine Agonist (>= 3 Months) Other Dopamine Agonist (< 3 Months) L-Dopa Monotherapy (>= 3 Months) L-Dopa Monotherapy (< 3 Months) Multiple Dopamine Agonists (>= 3 Months) Multiple Dopamine Agonists (< 3 Months) Neupro + L-Dopa (>= 3 Months) Neupro + L-Dopa (< 3 Months) Other Dopamine Agonist + L-Dopa (>= 3 Months) Other Dopamine Agonist + L-Dopa (< 3 Months) Multiple Dopamine Agonists + L-Dopa (>= 3 Months) Multiple Dopamine Agonists + L-Dopa (< 3 Months) Not Treated (>= 3 Months) Not Treated (< 3 Months)
    Arm/Group Description 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.
    Measure Participants 203 11 145 10 233 23 13 2 400 6 377 11 35 2 13 36
    Mean (Standard Deviation) [units on a scale]
    -2.5
    (14.7)
    -2.5
    (10.3)
    -2.2
    (11.1)
    -5.6
    (16.9)
    0.2
    (13.2)
    0.0
    (12.2)
    -1.2
    (13.8)
    3.5
    (6.4)
    -1.2
    (14.2)
    -1.5
    (17.5)
    -2.5
    (13.9)
    8.6
    (13.5)
    1.5
    (14.7)
    20.0
    (29.7)
    -3.2
    (10.8)
    4.1
    (15.0)
    2. Secondary Outcome
    Title Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 32 of Part IV at Visit 7 (Month 33)
    Description 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).
    Time Frame From Baseline to Visit 7 (Month 33)

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Neupro Monotherapy (>= 3 Months) Neupro Monotherapy (< 3 Months) Other Dopamine Agonist (>= 3 Months) Other Dopamine Agonist (< 3 Months) L-Dopa Monotherapy (>= 3 Months) L-Dopa Monotherapy (< 3 Months) Multiple Dopamine Agonists (>= 3 Months) Multiple Dopamine Agonists (< 3 Months) Neupro + L-Dopa (>= 3 Months) Neupro + L-Dopa (< 3 Months) Other Dopamine Agonist + L-Dopa (>= 3 Months) Other Dopamine Agonist + L-Dopa (< 3 Months) Multiple Dopamine Agonists + L-Dopa (>= 3 Months) Multiple Dopamine Agonists + L-Dopa (< 3 Months) Not Treated (>= 3 Months) Not Treated (< 3 Months)
    Arm/Group Description 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.
    Measure Participants 204 11 145 10 233 23 13 2 400 6 377 11 35 2 13 37
    Mean (Standard Deviation) [units on a scale]
    -0.1
    (0.7)
    -0.2
    (0.6)
    -0.1
    (0.5)
    0.0
    (0.8)
    0.1
    (0.8)
    -0.1
    (0.5)
    -0.1
    (0.5)
    0.0
    (0.0)
    0.1
    (0.7)
    0.2
    (1.0)
    0.2
    (0.7)
    0.2
    (0.6)
    0.2
    (0.7)
    0.5
    (0.7)
    -0.2
    (0.4)
    0.1
    (0.8)
    3. Secondary Outcome
    Title Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 33 of Part IV at Visit 7 (Month 33)
    Description 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).
    Time Frame From Baseline to Visit 7 (Month 33)

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Neupro Monotherapy (>= 3 Months) Neupro Monotherapy (< 3 Months) Other Dopamine Agonist (>= 3 Months) Other Dopamine Agonist (< 3 Months) L-Dopa Monotherapy (>= 3 Months) L-Dopa Monotherapy (< 3 Months) Multiple Dopamine Agonists (>= 3 Months) Multiple Dopamine Agonists (< 3 Months) Neupro + L-Dopa (>= 3 Months) Neupro + L-Dopa (< 3 Months) Other Dopamine Agonist + L-Dopa (>= 3 Months) Other Dopamine Agonist + L-Dopa (< 3 Months) Multiple Dopamine Agonists + L-Dopa (>= 3 Months) Multiple Dopamine Agonists + L-Dopa (< 3 Months) Not Treated (>= 3 Months) Not Treated (< 3 Months)
    Arm/Group Description 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.
    Measure Participants 204 11 145 10 233 23 13 2 400 6 377 11 35 2 13 37
    Mean (Standard Deviation) [units on a scale]
    -0.1
    (0.7)
    -0.2
    (0.4)
    -0.1
    (0.4)
    -0.1
    (0.7)
    0.0
    (0.8)
    -0.0
    (0.7)
    -0.1
    (0.6)
    0.0
    (0.0)
    0.0
    (0.7)
    0.0
    (0.6)
    0.1
    (0.7)
    -0.1
    (0.7)
    0.2
    (0.8)
    0.0
    (0.0)
    -0.1
    (0.3)
    0.2
    (0.6)
    4. Secondary Outcome
    Title Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Question 39 of Part IV at Visit 7 (Month 33)
    Description 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).
    Time Frame 33 months

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Neupro Monotherapy (>= 3 Months) Neupro Monotherapy (< 3 Months) Other Dopamine Agonist (>= 3 Months) Other Dopamine Agonist (< 3 Months) L-Dopa Monotherapy (>= 3 Months) L-Dopa Monotherapy (< 3 Months) Multiple Dopamine Agonists (>= 3 Months) Multiple Dopamine Agonists (< 3 Months) Neupro + L-Dopa (>= 3 Months) Neupro + L-Dopa (< 3 Months) Other Dopamine Agonist + L-Dopa (>= 3 Months) Other Dopamine Agonist + L-Dopa (< 3 Months) Multiple Dopamine Agonists + L-Dopa (>= 3 Months) Multiple Dopamine Agonists + L-Dopa (< 3 Months) Not Treated (>= 3 Months) Not Treated (< 3 Months)
    Arm/Group Description 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.
    Measure Participants 204 11 145 10 233 23 13 2 400 6 377 11 35 2 13 37
    Mean (Standard Deviation) [units on a scale]
    -0.2
    (0.9)
    0.5
    (0.9)
    -0.1
    (0.8)
    0.1
    (0.9)
    0.1
    (0.9)
    0.1
    (1.1)
    -0.4
    (0.9)
    0.0
    (0.0)
    0.0
    (0.8)
    0.0
    (0.0)
    0.2
    (0.9)
    0.2
    (0.9)
    -0.0
    (1.0)
    1.5
    (2.1)
    0.0
    (0.4)
    0.3
    (0.9)
    5. Secondary Outcome
    Title Change From Baseline in Nocturnal Dystonia Cramp Score (NADCS) at Visit 7 (Month 33)
    Description 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.
    Time Frame 33 months

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Neupro Monotherapy (>= 3 Months) Neupro Monotherapy (< 3 Months) Other Dopamine Agonist (>= 3 Months) Other Dopamine Agonist (< 3 Months) L-Dopa Monotherapy (>= 3 Months) L-Dopa Monotherapy (< 3 Months) Multiple Dopamine Agonists (>= 3 Months) Multiple Dopamine Agonists (< 3 Months) Neupro + L-Dopa (>= 3 Months) Neupro + L-Dopa (< 3 Months) Other Dopamine Agonist + L-Dopa (>= 3 Months) Other Dopamine Agonist + L-Dopa (< 3 Months) Multiple Dopamine Agonists + L-Dopa (>= 3 Months) Multiple Dopamine Agonists + L-Dopa (< 3 Months) Not Treated (>= 3 Months) Not Treated (< 3 Months)
    Arm/Group Description 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.
    Measure Participants 204 11 145 10 232 23 13 2 400 6 376 11 34 2 13 37
    Mean (Standard Deviation) [units on a scale]
    -0.27
    (1.79)
    1.36
    (3.51)
    -0.15
    (1.48)
    0.05
    (2.53)
    -0.09
    (1.84)
    -0.26
    (2.30)
    -0.73
    (1.49)
    0.75
    (1.06)
    -0.03
    (2.06)
    -0.42
    (2.01)
    -0.03
    (2.07)
    1.05
    (1.39)
    -0.01
    (1.90)
    3.25
    (4.60)
    -0.38
    (1.10)
    0.22
    (2.19)
    6. Secondary Outcome
    Title Hoehn & Yahr Stage at Visit 7 (Month 33)
    Description 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
    Time Frame 33 months

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Neupro Monotherapy (>= 3 Months) Neupro Monotherapy (< 3 Months) Other Dopamine Agonist (>= 3 Months) Other Dopamine Agonist (< 3 Months) L-Dopa Monotherapy (>= 3 Months) L-Dopa Monotherapy (< 3 Months) Multiple Dopamine Agonists (>= 3 Months) Multiple Dopamine Agonists (< 3 Months) Neupro + L-Dopa (>= 3 Months) Neupro + L-Dopa (< 3 Months) Other Dopamine Agonist + L-Dopa (>= 3 Months) Other Dopamine Agonist + L-Dopa (< 3 Months) Multiple Dopamine Agonists + L-Dopa (>= 3 Months) Multiple Dopamine Agonists + L-Dopa (< 3 Months) Not Treated (>= 3 Months) Not Treated (< 3 Months)
    Arm/Group Description 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.
    Measure Participants 207 11 146 11 234 23 13 2 401 6 378 11 36 2 13 37
    0
    2
    0.1%
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    2
    NaN
    0
    NaN
    1
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    1
    55
    2.5%
    1
    NaN
    48
    NaN
    0
    NaN
    29
    NaN
    1
    NaN
    0
    NaN
    1
    NaN
    29
    NaN
    2
    NaN
    37
    NaN
    0
    NaN
    2
    NaN
    0
    NaN
    4
    NaN
    3
    NaN
    2
    112
    5.2%
    4
    NaN
    76
    NaN
    6
    NaN
    118
    NaN
    12
    NaN
    7
    NaN
    1
    NaN
    186
    NaN
    2
    NaN
    192
    NaN
    2
    NaN
    15
    NaN
    1
    NaN
    7
    NaN
    19
    NaN
    3
    28
    1.3%
    4
    NaN
    19
    NaN
    4
    NaN
    70
    NaN
    8
    NaN
    5
    NaN
    0
    NaN
    131
    NaN
    2
    NaN
    119
    NaN
    4
    NaN
    13
    NaN
    0
    NaN
    1
    NaN
    11
    NaN
    4
    8
    0.4%
    2
    NaN
    2
    NaN
    0
    NaN
    14
    NaN
    2
    NaN
    1
    NaN
    0
    NaN
    46
    NaN
    0
    NaN
    24
    NaN
    4
    NaN
    3
    NaN
    1
    NaN
    1
    NaN
    3
    NaN
    5
    1
    0%
    0
    NaN
    0
    NaN
    0
    NaN
    3
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    6
    NaN
    0
    NaN
    4
    NaN
    1
    NaN
    2
    NaN
    0
    NaN
    0
    NaN
    1
    NaN
    No Data/Missing
    1
    0%
    0
    NaN
    1
    NaN
    1
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    1
    NaN
    0
    NaN
    1
    NaN
    0
    NaN
    1
    NaN
    0
    NaN
    0
    NaN
    0
    NaN
    7. Secondary Outcome
    Title Reported Adverse Events of Cardiac Valve Fibrosis During the Study (up to 33 Months)
    Description 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.
    Time Frame 33 months

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Associated With Rotigotine Not Associated With Rotigotine
    Arm/Group Description 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. 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.
    Measure Participants 1390 1328
    Cardiac valve disease
    1
    1
    Cardiac valve sclerosis
    0
    2
    Aortic valve sclerosis
    1
    0

    Adverse Events

    Time Frame Adverse Events (AEs) were collected during the course of the study from Baseline (Visit 1) up to Visit 7 (Month 33 ± 30 days).
    Adverse Event Reporting Description 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.
    Arm/Group Title Associated With Rotigotine Not Associated With Rotigotine
    Arm/Group Description 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. 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.
    All Cause Mortality
    Associated With Rotigotine Not Associated With Rotigotine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Associated With Rotigotine Not Associated With Rotigotine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 261/1390 (18.8%) 269/1328 (20.3%)
    Blood and lymphatic system disorders
    Anaemia 1/1390 (0.1%) 1 3/1328 (0.2%) 3
    Haemorrhagic anaemia 1/1390 (0.1%) 1 0/1328 (0%) 0
    Iron deficiency anaemia 2/1390 (0.1%) 2 0/1328 (0%) 0
    Pancytopenia 1/1390 (0.1%) 1 0/1328 (0%) 0
    Neutropenia 1/1390 (0.1%) 1 0/1328 (0%) 0
    Cardiac disorders
    Myocardial infarction 7/1390 (0.5%) 7 7/1328 (0.5%) 7
    Angina pectoris 3/1390 (0.2%) 3 3/1328 (0.2%) 3
    Acute myocardial infarction 1/1390 (0.1%) 1 2/1328 (0.2%) 2
    Acute coronary syndrome 0/1390 (0%) 0 2/1328 (0.2%) 2
    Angina unstable 1/1390 (0.1%) 1 1/1328 (0.1%) 1
    Myocardial ischaemia 0/1390 (0%) 0 1/1328 (0.1%) 1
    Cardiac failure 4/1390 (0.3%) 5 9/1328 (0.7%) 9
    Cardiac failure acute 1/1390 (0.1%) 1 0/1328 (0%) 0
    Cardio-respiratory distress 0/1390 (0%) 0 1/1328 (0.1%) 1
    Cardiogenic shock 0/1390 (0%) 0 1/1328 (0.1%) 1
    Cardiopulmonary failure 1/1390 (0.1%) 1 0/1328 (0%) 0
    Arrhythmia 0/1390 (0%) 0 3/1328 (0.2%) 3
    Bradycardia 1/1390 (0.1%) 1 2/1328 (0.2%) 2
    Bradyarrhythmia 0/1390 (0%) 0 2/1328 (0.2%) 2
    Tachyarrhythmia 0/1390 (0%) 0 2/1328 (0.2%) 2
    Atrial fibrillation 2/1390 (0.1%) 2 4/1328 (0.3%) 4
    Supraventricular tachycardia 1/1390 (0.1%) 1 1/1328 (0.1%) 1
    Atrial flutter 0/1390 (0%) 0 1/1328 (0.1%) 1
    Cardio-respiratory arrest 1/1390 (0.1%) 1 4/1328 (0.3%) 4
    Cardiac arrest 2/1390 (0.1%) 2 0/1328 (0%) 0
    Coronary artery disease 0/1390 (0%) 0 2/1328 (0.2%) 2
    Arteriosclerosis coronary artery 0/1390 (0%) 0 1/1328 (0.1%) 1
    Coronary artery occlusion 1/1390 (0.1%) 1 0/1328 (0%) 0
    Coronary artery restenosis 0/1390 (0%) 0 1/1328 (0.1%) 1
    Coronary artery stenosis 0/1390 (0%) 0 1/1328 (0.1%) 1
    Atrioventricular block third degree 3/1390 (0.2%) 3 0/1328 (0%) 0
    Mitral valve incompetence 0/1390 (0%) 0 3/1328 (0.2%) 3
    Ischaemic cardiomyopathy 1/1390 (0.1%) 1 1/1328 (0.1%) 1
    Tricuspid valve incompetence 0/1390 (0%) 0 2/1328 (0.2%) 2
    Aortic valve sclerosis 1/1390 (0.1%) 1 0/1328 (0%) 0
    Cardiac disorder 1/1390 (0.1%) 1 0/1328 (0%) 0
    Hypertensive heart disease 0/1390 (0%) 0 1/1328 (0.1%) 1
    Palpitations 1/1390 (0.1%) 1 0/1328 (0%) 0
    Cardiac valve disease 0/1390 (0%) 0 1/1328 (0.1%) 1
    Pericardial effusion 0/1390 (0%) 0 1/1328 (0.1%) 1
    Congenital, familial and genetic disorders
    Atrial septal defect 0/1390 (0%) 0 1/1328 (0.1%) 1
    Ear and labyrinth disorders
    Vertigo 3/1390 (0.2%) 3 0/1328 (0%) 0
    Vertigo positional 0/1390 (0%) 0 1/1328 (0.1%) 1
    Endocrine disorders
    Thyroiditis 0/1390 (0%) 0 1/1328 (0.1%) 1
    Cushing's syndrome 0/1390 (0%) 0 1/1328 (0.1%) 1
    Acromegaly 1/1390 (0.1%) 1 0/1328 (0%) 0
    Goitre 0/1390 (0%) 0 1/1328 (0.1%) 1
    Hyperthyroidism 1/1390 (0.1%) 2 0/1328 (0%) 0
    Hypothyroidism 1/1390 (0.1%) 1 0/1328 (0%) 0
    Eye disorders
    Cataract 0/1390 (0%) 0 2/1328 (0.2%) 2
    Retinal haemorrhage 0/1390 (0%) 0 1/1328 (0.1%) 1
    Macular degeneration 0/1390 (0%) 0 1/1328 (0.1%) 1
    Gastrointestinal disorders
    Inguinal hernia 5/1390 (0.4%) 5 5/1328 (0.4%) 5
    Diarrhoea 2/1390 (0.1%) 2 3/1328 (0.2%) 4
    Gastrointestinal haemorrhage 1/1390 (0.1%) 1 3/1328 (0.2%) 3
    Upper gastrointestinal haemorrhage 1/1390 (0.1%) 1 0/1328 (0%) 0
    Crohn's disease 1/1390 (0.1%) 1 1/1328 (0.1%) 1
    Enterocolitis 0/1390 (0%) 0 1/1328 (0.1%) 1
    Gastrointestinal inflammation 0/1390 (0%) 0 1/1328 (0.1%) 1
    Constipation 2/1390 (0.1%) 2 1/1328 (0.1%) 1
    Dysphagia 1/1390 (0.1%) 1 1/1328 (0.1%) 1
    Faecal incontinence 0/1390 (0%) 0 1/1328 (0.1%) 1
    Nausea 2/1390 (0.1%) 2 0/1328 (0%) 0
    Vomiting 0/1390 (0%) 0 1/1328 (0.1%) 1
    Colonic polyp 1/1390 (0.1%) 1 1/1328 (0.1%) 1
    Anal fistula 1/1390 (0.1%) 1 0/1328 (0%) 0
    Gastrointestinal fistula 1/1390 (0.1%) 1 0/1328 (0%) 0
    Ileus 1/1390 (0.1%) 1 0/1328 (0%) 0
    Mechanical ileus 1/1390 (0.1%) 1 0/1328 (0%) 0
    Abdominal hernia 0/1390 (0%) 0 1/1328 (0.1%) 1
    Pancreatitis necrotising 1/1390 (0.1%) 1 0/1328 (0%) 0
    Colitis ulcerative 0/1390 (0%) 0 1/1328 (0.1%) 2
    Hiatus hernia 1/1390 (0.1%) 1 0/1328 (0%) 0
    Duodenal ulcer 1/1390 (0.1%) 1 0/1328 (0%) 0
    Dyspepsia 1/1390 (0.1%) 1 0/1328 (0%) 0
    Faecaloma 1/1390 (0.1%) 1 0/1328 (0%) 0
    Gastritis 1/1390 (0.1%) 1 0/1328 (0%) 0
    Abdominal pain upper 0/1390 (0%) 0 1/1328 (0.1%) 1
    Intestinal haemorrhage 1/1390 (0.1%) 1 0/1328 (0%) 0
    Large intestine perforation 0/1390 (0%) 0 1/1328 (0.1%) 1
    Coeliac disease 1/1390 (0.1%) 1 0/1328 (0%) 0
    Varices oesophageal 0/1390 (0%) 0 1/1328 (0.1%) 1
    Pancreatic pseudocyst 1/1390 (0.1%) 1 0/1328 (0%) 0
    Peptic ulcer 1/1390 (0.1%) 1 0/1328 (0%) 0
    Ascites 1/1390 (0.1%) 1 0/1328 (0%) 0
    Umbilical hernia 0/1390 (0%) 0 1/1328 (0.1%) 1
    General disorders
    Death 7/1390 (0.5%) 7 5/1328 (0.4%) 5
    Sudden death 0/1390 (0%) 0 2/1328 (0.2%) 2
    General physical health deterioration 3/1390 (0.2%) 3 2/1328 (0.2%) 2
    Orthostatic intolerance 0/1390 (0%) 0 2/1328 (0.2%) 2
    Influenza like illness 0/1390 (0%) 0 1/1328 (0.1%) 1
    Multi-organ failure 1/1390 (0.1%) 1 0/1328 (0%) 0
    Unevaluable event 0/1390 (0%) 0 1/1328 (0.1%) 1
    Chest pain 2/1390 (0.1%) 2 3/1328 (0.2%) 3
    Pain 1/1390 (0.1%) 1 0/1328 (0%) 0
    Oedema peripheral 1/1390 (0.1%) 1 2/1328 (0.2%) 2
    Gait disturbance 1/1390 (0.1%) 1 1/1328 (0.1%) 1
    Application site rash 1/1390 (0.1%) 1 0/1328 (0%) 0
    Fatigue 1/1390 (0.1%) 1 0/1328 (0%) 0
    Drug intolerance 1/1390 (0.1%) 1 0/1328 (0%) 0
    Hepatobiliary disorders
    Cholelithiasis 2/1390 (0.1%) 2 2/1328 (0.2%) 2
    Cholecystitis 0/1390 (0%) 0 1/1328 (0.1%) 1
    Cholecystitis acute 0/1390 (0%) 0 1/1328 (0.1%) 1
    Cholangitis 1/1390 (0.1%) 1 2/1328 (0.2%) 2
    Hepatic cirrhosis 1/1390 (0.1%) 1 1/1328 (0.1%) 1
    Cirrhosis alcoholic 0/1390 (0%) 0 1/1328 (0.1%) 1
    Cholestasis 0/1390 (0%) 0 1/1328 (0.1%) 1
    Jaundice 0/1390 (0%) 0 1/1328 (0.1%) 1
    Autoimmune hepatitis 1/1390 (0.1%) 1 0/1328 (0%) 0
    Hepatitis alcoholic 0/1390 (0%) 0 1/1328 (0.1%) 1
    Gallbladder disorder 0/1390 (0%) 0 1/1328 (0.1%) 1
    Infections and infestations
    Pneumonia 4/1390 (0.3%) 4 8/1328 (0.6%) 8
    Bronchopneumonia 1/1390 (0.1%) 1 2/1328 (0.2%) 2
    Bronchitis acute 0/1390 (0%) 0 1/1328 (0.1%) 1
    Lung infection 1/1390 (0.1%) 1 0/1328 (0%) 0
    Gastroenteritis 1/1390 (0.1%) 1 1/1328 (0.1%) 1
    Abscess intestinal 0/1390 (0%) 0 1/1328 (0.1%) 1
    Appendicitis 0/1390 (0%) 0 1/1328 (0.1%) 1
    Gastrointestinal infection 0/1390 (0%) 0 1/1328 (0.1%) 1
    Rectal abscess 0/1390 (0%) 0 1/1328 (0.1%) 1
    Sepsis 2/1390 (0.1%) 2 4/1328 (0.3%) 4
    Urinary tract infection 3/1390 (0.2%) 3 1/1328 (0.1%) 1
    Cystitis 0/1390 (0%) 0 1/1328 (0.1%) 1
    Pyelonephritis 1/1390 (0.1%) 1 0/1328 (0%) 0
    Urethritis 0/1390 (0%) 0 1/1328 (0.1%) 1
    Chronic sinusitis 1/1390 (0.1%) 1 0/1328 (0%) 0
    Laryngotracheo bronchitis 0/1390 (0%) 0 1/1328 (0.1%) 1
    Tracheobronchitis 1/1390 (0.1%) 1 0/1328 (0%) 0
    Upper respiratory tract infection 0/1390 (0%) 0 1/1328 (0.1%) 1
    Pneumonia staphylococcal 0/1390 (0%) 0 1/1328 (0.1%) 1
    Staphylococcal infection 1/1390 (0.1%) 1 0/1328 (0%) 0
    Staphylococcal sepsis 1/1390 (0.1%) 1 0/1328 (0%) 0
    Arthritis infective 1/1390 (0.1%) 1 0/1328 (0%) 0
    Intervertebral discitis 0/1390 (0%) 0 1/1328 (0.1%) 1
    Endocarditis 0/1390 (0%) 0 2/1328 (0.2%) 2
    Opportunistic infection 1/1390 (0.1%) 1 0/1328 (0%) 0
    Postoperative wound infection 1/1390 (0.1%) 1 0/1328 (0%) 0
    Gastroenteritis Norwalk virus 0/1390 (0%) 0 1/1328 (0.1%) 1
    Pseudomembranous colitis 1/1390 (0.1%) 1 0/1328 (0%) 0
    Escherichia urinary tract infection 0/1390 (0%) 0 1/1328 (0.1%) 1
    Mycotoxicosis 1/1390 (0.1%) 1 0/1328 (0%) 0
    Helicobacter gastritis 0/1390 (0%) 0 1/1328 (0.1%) 1
    Herpes zoster 1/1390 (0.1%) 1 0/1328 (0%) 0
    Influenza 0/1390 (0%) 0 1/1328 (0.1%) 1
    Necrotising fasciitis 0/1390 (0%) 0 1/1328 (0.1%) 1
    Pseudomonas infection 1/1390 (0.1%) 1 0/1328 (0%) 0
    Pulmonary tuberculosis 0/1390 (0%) 0 1/1328 (0.1%) 1
    Viral infection 0/1390 (0%) 0 1/1328 (0.1%) 1
    Injury, poisoning and procedural complications
    Fall 8/1390 (0.6%) 8 8/1328 (0.6%) 9
    Road traffic accident 1/1390 (0.1%) 1 2/1328 (0.2%) 2
    Femur fracture 5/1390 (0.4%) 5 1/1328 (0.1%) 1
    Hip fracture 1/1390 (0.1%) 1 3/1328 (0.2%) 3
    Ankle fracture 1/1390 (0.1%) 1 1/1328 (0.1%) 1
    Femoral neck fracture 0/1390 (0%) 0 2/1328 (0.2%) 2
    Lower limb fracture 2/1390 (0.1%) 2 0/1328 (0%) 0
    Fibula fracture 1/1390 (0.1%) 1 0/1328 (0%) 0
    Lumbar vertebral fracture 1/1390 (0.1%) 1 3/1328 (0.2%) 3
    Thoracic vertebral fracture 2/1390 (0.1%) 2 1/1328 (0.1%) 1
    Cervical vertebral fracture 1/1390 (0.1%) 1 0/1328 (0%) 0
    Dislocation of vertebra 1/1390 (0.1%) 1 0/1328 (0%) 0
    Spinal fracture 0/1390 (0%) 0 1/1328 (0.1%) 1
    Humerus fracture 2/1390 (0.1%) 2 2/1328 (0.2%) 2
    Upper limb fracture 1/1390 (0.1%) 1 2/1328 (0.2%) 2
    Clavicle fracture 0/1390 (0%) 0 1/1328 (0.1%) 1
    Forearm fracture 1/1390 (0.1%) 1 0/1328 (0%) 0
    Hand fracture 0/1390 (0%) 0 1/1328 (0.1%) 1
    Ulna fracture 0/1390 (0%) 0 1/1328 (0.1%) 1
    Meniscus lesion 3/1390 (0.2%) 3 1/1328 (0.1%) 1
    Joint injury 2/1390 (0.1%) 2 0/1328 (0%) 0
    Limb injury 0/1390 (0%) 0 1/1328 (0.1%) 1
    Device dislocation 2/1390 (0.1%) 2 0/1328 (0%) 0
    Device malfunction 0/1390 (0%) 0 1/1328 (0.1%) 1
    Dislocation of joint prosthesis 1/1390 (0.1%) 1 0/1328 (0%) 0
    Implantable defibrillator malfunction 0/1390 (0%) 0 1/1328 (0.1%) 1
    Pelvic fracture 2/1390 (0.1%) 2 2/1328 (0.2%) 2
    Acetabulum fracture 1/1390 (0.1%) 1 0/1328 (0%) 0
    Subdural haematoma 1/1390 (0.1%) 1 1/1328 (0.1%) 1
    Subdural haemorrhage 1/1390 (0.1%) 1 0/1328 (0%) 0
    Traumatic brain injury 1/1390 (0.1%) 1 0/1328 (0%) 0
    Rib fracture 1/1390 (0.1%) 1 3/1328 (0.2%) 3
    Procedural pain 0/1390 (0%) 0 1/1328 (0.1%) 1
    Procedural site reaction 1/1390 (0.1%) 1 0/1328 (0%) 0
    Wound dehiscence 0/1390 (0%) 0 1/1328 (0.1%) 1
    Head injury 1/1390 (0.1%) 1 0/1328 (0%) 0
    Pharyngeal injury 1/1390 (0.1%) 1 0/1328 (0%) 0
    Vertebral injury 0/1390 (0%) 0 1/1328 (0.1%) 1
    Contusion 1/1390 (0.1%) 1 1/1328 (0.1%) 1
    Skin laceration 1/1390 (0.1%) 1 0/1328 (0%) 0
    Joint dislocation 0/1390 (0%) 0 2/1328 (0.2%) 2
    Feeding tube complication 1/1390 (0.1%) 1 0/1328 (0%) 0
    Brachial plexus injury 1/1390 (0.1%) 1 0/1328 (0%) 0
    Skull fracture 1/1390 (0.1%) 1 0/1328 (0%) 0
    Investigations
    Blood glucose increased 0/1390 (0%) 0 1/1328 (0.1%) 1
    Prostatic specific antigen increased 0/1390 (0%) 0 1/1328 (0.1%) 1
    Electrocardiogram QT corrected interval prolonged 1/1390 (0.1%) 1 0/1328 (0%) 0
    Heart rate increased 0/1390 (0%) 0 1/1328 (0.1%) 1
    Investigation 0/1390 (0%) 0 1/1328 (0.1%) 1
    Metabolism and nutrition disorders
    Dehydration 7/1390 (0.5%) 7 1/1328 (0.1%) 1
    Hypovolaemia 0/1390 (0%) 0 1/1328 (0.1%) 1
    Diabetes mellitus 1/1390 (0.1%) 1 1/1328 (0.1%) 2
    Diabetes mellitus non-insulin-dependent 0/1390 (0%) 0 1/1328 (0.1%) 1
    Hypoglycaemia 0/1390 (0%) 0 2/1328 (0.2%) 2
    Anorexia 0/1390 (0%) 0 1/1328 (0.1%) 1
    Hypochloraemia 1/1390 (0.1%) 1 0/1328 (0%) 0
    Starvation 1/1390 (0.1%) 1 0/1328 (0%) 0
    Hyperglycaemia 0/1390 (0%) 0 1/1328 (0.1%) 1
    Hypokalaemia 0/1390 (0%) 0 1/1328 (0.1%) 1
    Hyponatraemia 1/1390 (0.1%) 1 0/1328 (0%) 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis 9/1390 (0.6%) 9 10/1328 (0.8%) 11
    Spinal osteoarthritis 2/1390 (0.1%) 2 0/1328 (0%) 0
    Back pain 4/1390 (0.3%) 4 8/1328 (0.6%) 10
    Mobility decreased 0/1390 (0%) 0 1/1328 (0.1%) 1
    Musculoskeletal stiffness 1/1390 (0.1%) 1 0/1328 (0%) 0
    Neck pain 0/1390 (0%) 0 1/1328 (0.1%) 1
    Pain in extremity 0/1390 (0%) 0 1/1328 (0.1%) 1
    Posture abnormal 0/1390 (0%) 0 1/1328 (0.1%) 1
    Intervertebral disc protrusion 6/1390 (0.4%) 7 6/1328 (0.5%) 6
    Intervertebral disc disorder 2/1390 (0.1%) 2 2/1328 (0.2%) 2
    Lumbar spinal stenosis 4/1390 (0.3%) 4 5/1328 (0.4%) 5
    Cervical spinal stenosis 1/1390 (0.1%) 1 0/1328 (0%) 0
    Arthropathy 4/1390 (0.3%) 6 0/1328 (0%) 0
    Exostosis 1/1390 (0.1%) 1 0/1328 (0%) 0
    Osteonecrosis 0/1390 (0%) 0 1/1328 (0.1%) 1
    Osteosclerosis 1/1390 (0.1%) 1 0/1328 (0%) 0
    Spinal disorder 1/1390 (0.1%) 1 0/1328 (0%) 0
    Bone pain 1/1390 (0.1%) 1 2/1328 (0.2%) 2
    Osteochondrosis 1/1390 (0.1%) 1 1/1328 (0.1%) 1
    Arthralgia 0/1390 (0%) 0 2/1328 (0.2%) 2
    Synovial cyst 0/1390 (0%) 0 2/1328 (0.2%) 2
    Tendon disorder 1/1390 (0.1%) 1 0/1328 (0%) 0
    Tendonitis 0/1390 (0%) 0 1/1328 (0.1%) 1
    Rotator cuff syndrome 1/1390 (0.1%) 1 0/1328 (0%) 0
    Muscle tightness 1/1390 (0.1%) 1 0/1328 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer 4/1390 (0.3%) 4 3/1328 (0.2%) 3
    Breast cancer metastatic 1/1390 (0.1%) 1 0/1328 (0%) 0
    Breast cancer recurrent 1/1390 (0.1%) 1 0/1328 (0%) 0
    Prostate cancer 2/1390 (0.1%) 2 2/1328 (0.2%) 2
    Bladder cancer 0/1390 (0%) 0 1/1328 (0.1%) 1
    Metastatic carcinoma of the bladder 1/1390 (0.1%) 3 0/1328 (0%) 0
    Colon cancer 1/1390 (0.1%) 1 0/1328 (0%) 0
    Colon cancer recurrent 0/1390 (0%) 0 1/1328 (0.1%) 1
    Gastric cancer 0/1390 (0%) 0 1/1328 (0.1%) 1
    Gastric cancer recurrent 0/1390 (0%) 0 1/1328 (0.1%) 1
    Neoplasm malignant 0/1390 (0%) 0 1/1328 (0.1%) 1
    Squamous cell carcinoma 0/1390 (0%) 0 1/1328 (0.1%) 1
    Renal cell carcinoma stage unspecified 0/1390 (0%) 0 2/1328 (0.2%) 2
    Benign neoplasm of thyroid gland 1/1390 (0.1%) 1 1/1328 (0.1%) 1
    Colon neoplasm 1/1390 (0.1%) 1 0/1328 (0%) 0
    Pituitary tumour benign 0/1390 (0%) 0 1/1328 (0.1%) 1
    Genital neoplasm malignant female 0/1390 (0%) 0 1/1328 (0.1%) 1
    Gastrointestinal carcinoma 0/1390 (0%) 0 1/1328 (0.1%) 1
    Chronic myeloid leukaemia 0/1390 (0%) 0 1/1328 (0.1%) 1
    Colon adenoma 0/1390 (0%) 0 1/1328 (0.1%) 1
    Meningeal neoplasm 0/1390 (0%) 0 1/1328 (0.1%) 1
    Malignant neoplasm of conjunctiva 0/1390 (0%) 0 1/1328 (0.1%) 1
    Oesophageal adenocarcinoma metastatic 0/1390 (0%) 0 1/1328 (0.1%) 1
    Pancreatic carcinoma 0/1390 (0%) 0 1/1328 (0.1%) 1
    Gammopathy 1/1390 (0.1%) 1 0/1328 (0%) 0
    Prostatic adenoma 0/1390 (0%) 0 1/1328 (0.1%) 1
    Lung neoplasm malignant 0/1390 (0%) 0 1/1328 (0.1%) 1
    Malignant melanoma 1/1390 (0.1%) 1 0/1328 (0%) 0
    Benign neoplasm of bladder 1/1390 (0.1%) 1 0/1328 (0%) 0
    Bladder neoplasm 1/1390 (0.1%) 1 0/1328 (0%) 0
    Uterine leiomyoma 1/1390 (0.1%) 1 0/1328 (0%) 0
    Uterine cancer 0/1390 (0%) 0 1/1328 (0.1%) 1
    Nervous system disorders
    Parkinson's disease 39/1390 (2.8%) 47 32/1328 (2.4%) 38
    Parkinsonism 1/1390 (0.1%) 1 2/1328 (0.2%) 3
    Ischaemic stroke 8/1390 (0.6%) 8 7/1328 (0.5%) 7
    Cerebrovascular accident 2/1390 (0.1%) 3 3/1328 (0.2%) 3
    Cerebral haemorrhage 0/1390 (0%) 0 4/1328 (0.3%) 6
    Ischaemic cerebral infarction 1/1390 (0.1%) 1 1/1328 (0.1%) 1
    Cerebellar haematoma 0/1390 (0%) 0 1/1328 (0.1%) 1
    Cerebellar infarction 0/1390 (0%) 0 1/1328 (0.1%) 1
    Syncope 9/1390 (0.6%) 9 4/1328 (0.3%) 5
    Loss of consciousness 1/1390 (0.1%) 1 0/1328 (0%) 0
    Somnolence 0/1390 (0%) 0 1/1328 (0.1%) 1
    Dementia 4/1390 (0.3%) 4 5/1328 (0.4%) 5
    Progressive supranuclear palsy 1/1390 (0.1%) 1 1/1328 (0.1%) 1
    Carotid artery stenosis 0/1390 (0%) 0 4/1328 (0.3%) 4
    Cerebral hypoperfusion 0/1390 (0%) 0 1/1328 (0.1%) 1
    Hypokinesia 2/1390 (0.1%) 2 1/1328 (0.1%) 1
    Dyskinesia 0/1390 (0%) 0 1/1328 (0.1%) 1
    Movement disorder 0/1390 (0%) 0 1/1328 (0.1%) 1
    Multiple system atrophy 0/1390 (0%) 0 2/1328 (0.2%) 2
    Fine motor delay 0/1390 (0%) 0 1/1328 (0.1%) 1
    Nervous system disorder 1/1390 (0.1%) 1 0/1328 (0%) 0
    Dizziness 2/1390 (0.1%) 2 2/1328 (0.2%) 2
    Pseudoradicular syndrome 2/1390 (0.1%) 2 1/1328 (0.1%) 1
    Spinal cord haemorrhage 0/1390 (0%) 0 1/1328 (0.1%) 1
    Transient ischaemic attack 2/1390 (0.1%) 2 1/1328 (0.1%) 1
    Reversible ischaemic neurological deficit 0/1390 (0%) 0 1/1328 (0.1%) 1
    Headache 3/1390 (0.2%) 3 0/1328 (0%) 0
    Sciatica 0/1390 (0%) 0 2/1328 (0.2%) 2
    Lumbar radiculopathy 1/1390 (0.1%) 1 0/1328 (0%) 0
    Tremor 2/1390 (0.1%) 2 2/1328 (0.2%) 2
    Polyneuropathy 0/1390 (0%) 0 2/1328 (0.2%) 2
    Coma 1/1390 (0.1%) 1 0/1328 (0%) 0
    Diabetic hyperosmolar coma 0/1390 (0%) 0 1/1328 (0.1%) 1
    Aphasia 2/1390 (0.1%) 2 0/1328 (0%) 0
    Carpal tunnel syndrome 0/1390 (0%) 0 1/1328 (0.1%) 1
    Phrenic nerve paralysis 1/1390 (0.1%) 1 0/1328 (0%) 0
    Epilepsy 1/1390 (0.1%) 1 0/1328 (0%) 0
    Myoclonic epilepsy 1/1390 (0.1%) 1 0/1328 (0%) 0
    Autonomic nervous system imbalance 0/1390 (0%) 0 1/1328 (0.1%) 2
    Dystonia 1/1390 (0.1%) 1 0/1328 (0%) 0
    Hypertensive encephalopathy 0/1390 (0%) 0 1/1328 (0.1%) 1
    Hepatic encephalopathy 1/1390 (0.1%) 1 0/1328 (0%) 0
    Normal pressure hydrocephalus 1/1390 (0.1%) 1 0/1328 (0%) 0
    Cognitive disorder 1/1390 (0.1%) 1 0/1328 (0%) 0
    Migraine 0/1390 (0%) 0 1/1328 (0.1%) 1
    Drop attacks 1/1390 (0.1%) 1 0/1328 (0%) 0
    Paraesthesia 1/1390 (0.1%) 1 1/1328 (0.1%) 1
    Monoparesis 0/1390 (0%) 0 1/1328 (0.1%) 1
    Neuropathy peripheral 0/1390 (0%) 0 1/1328 (0.1%) 1
    Psychiatric disorders
    Depression 0/1390 (0%) 0 8/1328 (0.6%) 8
    Hallucination 2/1390 (0.1%) 2 2/1328 (0.2%) 2
    Hallucination, visual 2/1390 (0.1%) 2 1/1328 (0.1%) 1
    Confusional state 4/1390 (0.3%) 4 1/1328 (0.1%) 1
    Disorientation 1/1390 (0.1%) 1 1/1328 (0.1%) 1
    Anxiety 2/1390 (0.1%) 2 3/1328 (0.2%) 3
    Nervousness 1/1390 (0.1%) 1 0/1328 (0%) 0
    Delirium 1/1390 (0.1%) 1 1/1328 (0.1%) 1
    Sleep attacks 2/1390 (0.1%) 2 0/1328 (0%) 0
    Somatoform disorder 1/1390 (0.1%) 1 1/1328 (0.1%) 1
    Completed suicide 0/1390 (0%) 0 1/1328 (0.1%) 1
    Suicide attempt 1/1390 (0.1%) 1 0/1328 (0%) 0
    Anxiety disorder 0/1390 (0%) 0 1/1328 (0.1%) 1
    Cyclothymic disorder 1/1390 (0.1%) 1 0/1328 (0%) 0
    Insomnia 0/1390 (0%) 0 1/1328 (0.1%) 1
    Binge eating 0/1390 (0%) 0 1/1328 (0.1%) 1
    Impulse-control disorder 1/1390 (0.1%) 1 0/1328 (0%) 0
    Restlessness 0/1390 (0%) 0 1/1328 (0.1%) 1
    Mental disorder due to a general medical condition 0/1390 (0%) 0 1/1328 (0.1%) 1
    Mental status changes 1/1390 (0.1%) 1 0/1328 (0%) 0
    Psychotic disorder 1/1390 (0.1%) 1 0/1328 (0%) 0
    Hypersexuality 1/1390 (0.1%) 1 0/1328 (0%) 0
    Sleep disorder 0/1390 (0%) 0 1/1328 (0.1%) 1
    Post-traumatic stress disorder 0/1390 (0%) 0 1/1328 (0.1%) 1
    Renal and urinary disorders
    Renal failure acute 1/1390 (0.1%) 1 3/1328 (0.2%) 3
    Renal failure 1/1390 (0.1%) 1 1/1328 (0.1%) 1
    Acute prerenal failure 0/1390 (0%) 0 1/1328 (0.1%) 1
    Renal failure chronic 1/1390 (0.1%) 1 0/1328 (0%) 0
    Urethral stenosis 2/1390 (0.1%) 2 2/1328 (0.2%) 2
    Bladder disorder 0/1390 (0%) 0 1/1328 (0.1%) 1
    Urinary tract obstruction 1/1390 (0.1%) 1 0/1328 (0%) 0
    Neurogenic bladder 1/1390 (0.1%) 1 0/1328 (0%) 0
    Hydronephrosis 1/1390 (0.1%) 1 0/1328 (0%) 0
    Haematuria 1/1390 (0.1%) 1 0/1328 (0%) 0
    Reproductive system and breast disorders
    Uterine prolapse 1/1390 (0.1%) 1 0/1328 (0%) 0
    Vaginal prolapse 1/1390 (0.1%) 1 0/1328 (0%) 0
    Benign prostatic hyperplasia 0/1390 (0%) 0 2/1328 (0.2%) 2
    Ovarian cyst 0/1390 (0%) 0 1/1328 (0.1%) 1
    Epididymitis 0/1390 (0%) 0 1/1328 (0.1%) 1
    Vaginal haemorrhage 1/1390 (0.1%) 1 0/1328 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 4/1390 (0.3%) 4 2/1328 (0.2%) 2
    Sleep apnoea syndrome 4/1390 (0.3%) 4 1/1328 (0.1%) 1
    Hyperventilation 1/1390 (0.1%) 1 1/1328 (0.1%) 1
    Dyspnoea exertional 0/1390 (0%) 0 1/1328 (0.1%) 1
    Pickwickian syndrome 0/1390 (0%) 0 1/1328 (0.1%) 1
    Acute pulmonary oedema 0/1390 (0%) 0 1/1328 (0.1%) 1
    Pulmonary congestion 0/1390 (0%) 0 1/1328 (0.1%) 1
    Pulmonary oedema 0/1390 (0%) 0 1/1328 (0.1%) 1
    Pulmonary embolism 3/1390 (0.2%) 3 0/1328 (0%) 0
    Respiratory failure 2/1390 (0.1%) 2 0/1328 (0%) 0
    Acute respiratory failure 1/1390 (0.1%) 1 0/1328 (0%) 0
    Chronic obstructive pulmonary disease 2/1390 (0.1%) 2 0/1328 (0%) 0
    Pleural effusion 1/1390 (0.1%) 1 0/1328 (0%) 0
    Pneumothorax 0/1390 (0%) 0 1/1328 (0.1%) 1
    Pneumonia aspiration 0/1390 (0%) 0 1/1328 (0.1%) 1
    Pharyngeal haemorrhage 1/1390 (0.1%) 1 0/1328 (0%) 0
    Skin and subcutaneous tissue disorders
    Pyoderma gangrenosum 0/1390 (0%) 0 1/1328 (0.1%) 1
    Skin ulcer 1/1390 (0.1%) 1 0/1328 (0%) 0
    Angioneurotic oedema 1/1390 (0.1%) 1 0/1328 (0%) 0
    Decubitus ulcer 1/1390 (0.1%) 1 0/1328 (0%) 0
    Surgical and medical procedures
    Therapy regimen changed 3/1390 (0.2%) 3 1/1328 (0.1%) 1
    Device therapy 0/1390 (0%) 0 1/1328 (0.1%) 1
    Drug therapy changed 1/1390 (0.1%) 1 0/1328 (0%) 0
    Hospitalisation 0/1390 (0%) 0 1/1328 (0.1%) 1
    Rehabilitation therapy 0/1390 (0%) 0 1/1328 (0.1%) 1
    Deep brain stimulation 0/1390 (0%) 0 1/1328 (0.1%) 1
    Vascular disorders
    Hypertensive crisis 2/1390 (0.1%) 2 4/1328 (0.3%) 4
    Hypertension 4/1390 (0.3%) 4 2/1328 (0.2%) 2
    Femoral arterial stenosis 1/1390 (0.1%) 1 0/1328 (0%) 0
    Femoral artery occlusion 1/1390 (0.1%) 1 0/1328 (0%) 0
    Iliac artery stenosis 0/1390 (0%) 0 1/1328 (0.1%) 1
    Peripheral arterial occlusive disease 0/1390 (0%) 0 1/1328 (0.1%) 1
    Peripheral ischaemia 0/1390 (0%) 0 1/1328 (0.1%) 1
    Subclavian artery stenosis 0/1390 (0%) 0 1/1328 (0.1%) 1
    Deep vein thrombosis 1/1390 (0.1%) 1 1/1328 (0.1%) 1
    Jugular vein thrombosis 0/1390 (0%) 0 1/1328 (0.1%) 1
    Thrombophlebitis 1/1390 (0.1%) 1 0/1328 (0%) 0
    Circulatory collapse 1/1390 (0.1%) 1 1/1328 (0.1%) 1
    Hypovolaemic shock 0/1390 (0%) 0 1/1328 (0.1%) 1
    Hypotension 2/1390 (0.1%) 2 1/1328 (0.1%) 1
    Arterial occlusive disease 0/1390 (0%) 0 2/1328 (0.2%) 2
    Varicose ulceration 0/1390 (0%) 0 1/1328 (0.1%) 1
    Varicose vein 1/1390 (0.1%) 2 0/1328 (0%) 0
    Aortic aneurysm rupture 1/1390 (0.1%) 1 0/1328 (0%) 0
    Lymphoedema 0/1390 (0%) 0 1/1328 (0.1%) 1
    Venous thrombosis 1/1390 (0.1%) 1 0/1328 (0%) 0
    Femoral artery aneurysm 0/1390 (0%) 0 1/1328 (0.1%) 1
    Other (Not Including Serious) Adverse Events
    Associated With Rotigotine Not Associated With Rotigotine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 237/1390 (17.1%) 245/1328 (18.4%)
    Gastrointestinal disorders
    Nausea 105/1390 (7.6%) 120 85/1328 (6.4%) 101
    General disorders
    Fatigue 67/1390 (4.8%) 76 77/1328 (5.8%) 82
    Injury, poisoning and procedural complications
    Fall 49/1390 (3.5%) 60 67/1328 (5%) 79
    Psychiatric disorders
    Depression 54/1390 (3.9%) 55 72/1328 (5.4%) 74

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title UCB Clinical Trial Call Center
    Organization UCB
    Phone +1 877 822 9493 (UCB)
    Email
    Responsible Party:
    UCB Pharma
    ClinicalTrials.gov Identifier:
    NCT00599339
    Other Study ID Numbers:
    • SP0854
    First Posted:
    Jan 23, 2008
    Last Update Posted:
    Aug 9, 2018
    Last Verified:
    Jul 1, 2015