Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT00292227
Status:
COMPLETED
Last Update Posted:
2014-10-27
First Post:
2006-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Cardiac Effects of Rotigotine Transdermal System in Subjects With Advanced-stage Idiopathic Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C047508', 'term': 'rotigotine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+1 877 822 9493', 'title': 'UCB Clinical Trial Call Center', 'organization': 'UCB'}, 'certainAgreement': {'otherDetails': 'UCB has \\> 60 days but \\<= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events are reported for the whole study period including the adverse events that occured during moxifloxacin or placebo infusion on day 32 or day 39.', 'eventGroups': [{'id': 'EG000', 'title': 'Rotigotine Patch', 'description': 'Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.', 'otherNumAtRisk': 66, 'otherNumAffected': 63, 'seriousNumAtRisk': 66, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Patch', 'description': 'Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.', 'otherNumAtRisk': 64, 'otherNumAffected': 54, 'seriousNumAtRisk': 64, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': "Meniere's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Visual Disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 71, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 26, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Lip Dry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Lip Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Aphthous Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Application Site Irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Application Site Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Application Site Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Application Site Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Infusion Related Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Infusion Site Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Infusion Site Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Injection Site Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Tooth Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Herpes Simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Tinea Cruris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Failure Of Implant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Medical Device Site Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Joint Sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Limb Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Arthropod Bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Soft Tissue Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Traumatic Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Tooth Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Nail Avulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Skin Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Blood Glucose Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Blood Potassium Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Serum Ferritin Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Serum Ferritin Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Plantar Fasciitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 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'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 29, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': "Parkinson's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Disorientation', 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'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Abnormal Dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Nightmare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Psychotic Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Bruxism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Polyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pharyngolaryngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Postnasal Drip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Dermatitis Contact', 'stats': 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1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Varicose Vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Orthostatic Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'seriousEvents': [{'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI at Time of Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine Patch', 'description': 'Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}, {'id': 'OG001', 'title': 'Placebo Patch', 'description': 'Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.46', 'spread': '5.96', 'groupId': 'OG000'}, {'value': '1.13', 'spread': '6.86', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '90', 'paramValue': '-0.75', 'ciLowerLimit': '-2.63', 'ciUpperLimit': '1.12', 'estimateComment': 'The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.', 'groupDescription': 'The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.', 'testedNonInferiority': True, 'nonInferiorityComment': 'A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 20:00h, Day 42 20:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 20:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; only non-missing values were analyzed.'}, {'type': 'PRIMARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 1 Hour After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine Patch', 'description': 'Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}, {'id': 'OG001', 'title': 'Placebo Patch', 'description': 'Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.82', 'spread': '8.32', 'groupId': 'OG000'}, {'value': '1.67', 'spread': '7.25', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '90', 'paramValue': '-0.01', 'ciLowerLimit': '-2.21', 'ciUpperLimit': '2.19', 'estimateComment': 'The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.', 'groupDescription': 'The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.', 'testedNonInferiority': True, 'nonInferiorityComment': 'A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 21:00h, Day 42 21:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 21:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; only non-missing values were analyzed.'}, {'type': 'PRIMARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 2 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine Patch', 'description': 'Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}, {'id': 'OG001', 'title': 'Placebo Patch', 'description': 'Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.55', 'spread': '6.96', 'groupId': 'OG000'}, {'value': '1.78', 'spread': '6.76', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '90', 'paramValue': '0.84', 'ciLowerLimit': '-1.12', 'ciUpperLimit': '2.80', 'estimateComment': 'The direction of the estimate is Rotigotine - Placebo Mean difference was estimated from the ANCOVA model.', 'groupDescription': 'The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.', 'testedNonInferiority': True, 'nonInferiorityComment': 'A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 22:00h, Day 42 22:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 22:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; only non-missing values were analyzed.'}, {'type': 'PRIMARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 3 Hours After Patch Application on Day 42(Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine Patch', 'description': 'Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}, {'id': 'OG001', 'title': 'Placebo Patch', 'description': 'Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.02', 'spread': '7.98', 'groupId': 'OG000'}, {'value': '0.89', 'spread': '6.52', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '90', 'paramValue': '0.26', 'ciLowerLimit': '-1.80', 'ciUpperLimit': '2.32', 'estimateComment': 'The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.', 'groupDescription': 'The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.', 'testedNonInferiority': True, 'nonInferiorityComment': 'A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 23:00h, Day 42 23:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 23:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; only non-missing values were analyzed.'}, {'type': 'PRIMARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 4 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine Patch', 'description': 'Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}, {'id': 'OG001', 'title': 'Placebo Patch', 'description': 'Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.54', 'spread': '8.09', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '7.29', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '90', 'paramValue': '-0.11', 'ciLowerLimit': '-2.25', 'ciUpperLimit': '2.02', 'estimateComment': 'The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.', 'groupDescription': 'The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.', 'testedNonInferiority': True, 'nonInferiorityComment': 'A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 00:00h, Day 43 00:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 00:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; only non-missing values were analyzed.'}, {'type': 'PRIMARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 5 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine Patch', 'description': 'Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}, {'id': 'OG001', 'title': 'Placebo Patch', 'description': 'Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.17', 'spread': '7.97', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '8.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '90', 'paramValue': '0.07', 'ciLowerLimit': '-2.14', 'ciUpperLimit': '2.28', 'estimateComment': 'The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.', 'groupDescription': 'The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.', 'testedNonInferiority': True, 'nonInferiorityComment': 'A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 1:00h, Day 43 1:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 1:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; only non-missing values were analyzed.'}, {'type': 'PRIMARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 6 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine Patch', 'description': 'Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}, {'id': 'OG001', 'title': 'Placebo Patch', 'description': 'Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.62', 'spread': '8.57', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '7.39', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '90', 'paramValue': '-0.56', 'ciLowerLimit': '-2.84', 'ciUpperLimit': '1.72', 'estimateComment': 'The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.', 'groupDescription': 'The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.', 'testedNonInferiority': True, 'nonInferiorityComment': 'A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 2:00h, Day 43 2:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 2:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; only non-missing values were analyzed.'}, {'type': 'PRIMARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 7 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine Patch', 'description': 'Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}, {'id': 'OG001', 'title': 'Placebo Patch', 'description': 'Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.63', 'spread': '7.84', 'groupId': 'OG000'}, {'value': '-0.26', 'spread': '6.44', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '90', 'paramValue': '-0.26', 'ciLowerLimit': '-2.29', 'ciUpperLimit': '1.78', 'estimateComment': 'The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.', 'groupDescription': 'The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.', 'testedNonInferiority': True, 'nonInferiorityComment': 'A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 3:00h, Day 43 3:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 3:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; only non-missing values were analyzed.'}, {'type': 'PRIMARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 8 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine Patch', 'description': 'Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}, {'id': 'OG001', 'title': 'Placebo Patch', 'description': 'Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.31', 'spread': '8.41', 'groupId': 'OG000'}, {'value': '0.95', 'spread': '5.75', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '90', 'paramValue': '-1.17', 'ciLowerLimit': '-3.25', 'ciUpperLimit': '0.91', 'estimateComment': 'The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.', 'groupDescription': 'The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.', 'testedNonInferiority': True, 'nonInferiorityComment': 'A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 4:00h, Day 43 4:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 4:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; only non-missing values were analyzed.'}, {'type': 'PRIMARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 9 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine Patch', 'description': 'Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}, {'id': 'OG001', 'title': 'Placebo Patch', 'description': 'Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.39', 'spread': '7.10', 'groupId': 'OG000'}, {'value': '-1.97', 'spread': '7.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '90', 'paramValue': '1.69', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '3.73', 'estimateComment': 'The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.', 'groupDescription': 'The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.', 'testedNonInferiority': True, 'nonInferiorityComment': 'A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 5:00h, Day 43 5:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 5:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; only non-missing values were analyzed.'}, {'type': 'PRIMARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 10 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine Patch', 'description': 'Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}, {'id': 'OG001', 'title': 'Placebo Patch', 'description': 'Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.92', 'spread': '7.70', 'groupId': 'OG000'}, {'value': '0.58', 'spread': '6.52', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '90', 'paramValue': '0.31', 'ciLowerLimit': '-1.70', 'ciUpperLimit': '2.32', 'estimateComment': 'The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.', 'groupDescription': 'The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.', 'testedNonInferiority': True, 'nonInferiorityComment': 'A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 6:00h, Day 43 6:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 6:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; only non-missing values were analyzed.'}, {'type': 'PRIMARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 11 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine Patch', 'description': 'Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}, {'id': 'OG001', 'title': 'Placebo Patch', 'description': 'Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.94', 'spread': '9.64', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '5.90', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '90', 'paramValue': '1.65', 'ciLowerLimit': '-0.65', 'ciUpperLimit': '3.96', 'estimateComment': 'The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.', 'groupDescription': 'The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.', 'testedNonInferiority': True, 'nonInferiorityComment': 'A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 7:00h, Day 43 7:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 7:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; only non-missing values were analyzed.'}, {'type': 'PRIMARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 12 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine Patch', 'description': 'Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}, {'id': 'OG001', 'title': 'Placebo Patch', 'description': 'Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.16', 'spread': '5.65', 'groupId': 'OG000'}, {'value': '1.31', 'spread': '5.26', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '90', 'paramValue': '-0.21', 'ciLowerLimit': '-1.78', 'ciUpperLimit': '1.36', 'estimateComment': 'The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.', 'groupDescription': 'The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.', 'testedNonInferiority': True, 'nonInferiorityComment': 'A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 8:00h, Day 43 8:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 8:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; only non-missing values were analyzed.'}, {'type': 'PRIMARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 13 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine Patch', 'description': 'Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}, {'id': 'OG001', 'title': 'Placebo Patch', 'description': 'Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.83', 'spread': '6.70', 'groupId': 'OG000'}, {'value': '1.40', 'spread': '5.78', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '90', 'paramValue': '-0.53', 'ciLowerLimit': '-2.37', 'ciUpperLimit': '1.30', 'estimateComment': 'The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.', 'groupDescription': 'The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.', 'testedNonInferiority': True, 'nonInferiorityComment': 'A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 9:00h, Day 43 9:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 9:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; only non-missing values were analyzed.'}, {'type': 'PRIMARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 14 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine Patch', 'description': 'Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}, {'id': 'OG001', 'title': 'Placebo Patch', 'description': 'Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.83', 'spread': '6.96', 'groupId': 'OG000'}, {'value': '2.12', 'spread': '6.01', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '90', 'paramValue': '-0.41', 'ciLowerLimit': '-2.30', 'ciUpperLimit': '1.49', 'estimateComment': 'The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.', 'groupDescription': 'The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.', 'testedNonInferiority': True, 'nonInferiorityComment': 'A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 10:00h, Day 43 10:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 10:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; only non-missing values were analyzed.'}, {'type': 'PRIMARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 15 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine Patch', 'description': 'Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}, {'id': 'OG001', 'title': 'Placebo Patch', 'description': 'Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.15', 'spread': '6.42', 'groupId': 'OG000'}, {'value': '1.60', 'spread': '6.21', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '90', 'paramValue': '-0.50', 'ciLowerLimit': '-2.34', 'ciUpperLimit': '1.35', 'estimateComment': 'The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.', 'groupDescription': 'The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.', 'testedNonInferiority': True, 'nonInferiorityComment': 'A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 11:00h, Day 43 11:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 11:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; only non-missing values were analyzed.'}, {'type': 'PRIMARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 16 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine Patch', 'description': 'Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}, {'id': 'OG001', 'title': 'Placebo Patch', 'description': 'Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.21', 'spread': '6.96', 'groupId': 'OG000'}, {'value': '1.99', 'spread': '6.46', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '90', 'paramValue': '0.21', 'ciLowerLimit': '-1.76', 'ciUpperLimit': '2.17', 'estimateComment': 'The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.', 'groupDescription': 'The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.', 'testedNonInferiority': True, 'nonInferiorityComment': 'A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 12:00h, Day 43 12:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 12:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; only non-missing values were analyzed.'}, {'type': 'PRIMARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 17 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine Patch', 'description': 'Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}, {'id': 'OG001', 'title': 'Placebo Patch', 'description': 'Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.35', 'spread': '6.10', 'groupId': 'OG000'}, {'value': '2.59', 'spread': '5.82', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '90', 'paramValue': '-1.23', 'ciLowerLimit': '-2.99', 'ciUpperLimit': '0.53', 'estimateComment': 'The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.', 'groupDescription': 'The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.', 'testedNonInferiority': True, 'nonInferiorityComment': 'A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 13:00h, Day 43 13:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 13:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; only non-missing values were analyzed.'}, {'type': 'PRIMARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 18 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine Patch', 'description': 'Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}, {'id': 'OG001', 'title': 'Placebo Patch', 'description': 'Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.31', 'spread': '8.48', 'groupId': 'OG000'}, {'value': '1.29', 'spread': '6.43', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '90', 'paramValue': '-1.62', 'ciLowerLimit': '-3.87', 'ciUpperLimit': '0.63', 'estimateComment': 'The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.', 'groupDescription': 'The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.', 'testedNonInferiority': True, 'nonInferiorityComment': 'A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 14:00h, Day 43 14:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 14:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; only non-missing values were analyzed.'}, {'type': 'PRIMARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 19 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine Patch', 'description': 'Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}, {'id': 'OG001', 'title': 'Placebo Patch', 'description': 'Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.71', 'spread': '6.01', 'groupId': 'OG000'}, {'value': '1.51', 'spread': '5.65', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '90', 'paramValue': '-0.81', 'ciLowerLimit': '-2.55', 'ciUpperLimit': '0.93', 'estimateComment': 'The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.', 'groupDescription': 'The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.', 'testedNonInferiority': True, 'nonInferiorityComment': 'A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 15:00h, Day 43 15:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 15:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; only non-missing values were analyzed.'}, {'type': 'PRIMARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 20 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine Patch', 'description': 'Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}, {'id': 'OG001', 'title': 'Placebo Patch', 'description': 'Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.58', 'spread': '6.07', 'groupId': 'OG000'}, {'value': '1.90', 'spread': '5.95', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '90', 'paramValue': '-0.37', 'ciLowerLimit': '-2.13', 'ciUpperLimit': '1.39', 'estimateComment': 'The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.', 'groupDescription': 'The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.', 'testedNonInferiority': True, 'nonInferiorityComment': 'A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 16:00h, Day 43 16:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 16:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; only non-missing values were analyzed.'}, {'type': 'PRIMARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 21 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine Patch', 'description': 'Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}, {'id': 'OG001', 'title': 'Placebo Patch', 'description': 'Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.13', 'spread': '6.92', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '6.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '90', 'paramValue': '-0.68', 'ciLowerLimit': '-2.60', 'ciUpperLimit': '1.25', 'estimateComment': 'The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.', 'groupDescription': 'The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.', 'testedNonInferiority': True, 'nonInferiorityComment': 'A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 17:00h, Day 43 17:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 17:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; only non-missing values were analyzed.'}, {'type': 'PRIMARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 22 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine Patch', 'description': 'Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}, {'id': 'OG001', 'title': 'Placebo Patch', 'description': 'Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.45', 'spread': '6.60', 'groupId': 'OG000'}, {'value': '0.27', 'spread': '6.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '90', 'paramValue': '1.17', 'ciLowerLimit': '-0.69', 'ciUpperLimit': '3.03', 'estimateComment': 'The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.', 'groupDescription': 'The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.', 'testedNonInferiority': True, 'nonInferiorityComment': 'A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 18:00h, Day 43 18:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 18:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; only non-missing values were analyzed.'}, {'type': 'PRIMARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 23 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine Patch', 'description': 'Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}, {'id': 'OG001', 'title': 'Placebo Patch', 'description': 'Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.50', 'spread': '6.70', 'groupId': 'OG000'}, {'value': '0.64', 'spread': '6.43', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '90', 'paramValue': '0.80', 'ciLowerLimit': '-1.14', 'ciUpperLimit': '2.73', 'estimateComment': 'The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.', 'groupDescription': 'The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.', 'testedNonInferiority': True, 'nonInferiorityComment': 'A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 19:00h, Day 43 19:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 19:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; only non-missing values were analyzed.'}, {'type': 'PRIMARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 24 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotigotine Patch', 'description': 'Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}, {'id': 'OG001', 'title': 'Placebo Patch', 'description': 'Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.96', 'spread': '7.08', 'groupId': 'OG000'}, {'value': '-0.58', 'spread': '5.79', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '90', 'paramValue': '-0.42', 'ciLowerLimit': '-2.33', 'ciUpperLimit': '1.50', 'estimateComment': 'The direction of the estimate is Rotigotine - Placebo. Mean difference was estimated from the ANCOVA model.', 'groupDescription': 'The analysis was based on a non-inferiority comparison of rotigotine vs placebo using a 1-sided 95% confidence interval (or, equivalently, the upper limit of 2-sided 90% confidence interval) for the time-matched changes from Baseline in QTcI.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'The ANCOVA model included the factors site, treatment, gender, and time-matched baseline QTcI as covariate.', 'testedNonInferiority': True, 'nonInferiorityComment': 'A standard deviation of 12ms was assumed for sample size calculation. Sample size was calculated to have 90% power to show the non-inferiority of rotigotine against placebo with respect to the non-inferiority margin of 10ms (α=0.05, 1-sided).'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 20:00h, Day 43 20:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 20:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; only non-missing values were analyzed.'}, {'type': 'SECONDARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 2 Hours Before Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moxifloxacin Infusion', 'description': 'Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.'}, {'id': 'OG001', 'title': 'Placebo Infusion', 'description': 'Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.70', 'spread': '5.76', 'groupId': 'OG000'}, {'value': '1.29', 'spread': '6.48', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.34', 'ciLowerLimit': '-1.04', 'ciUpperLimit': '1.71', 'estimateComment': 'The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.', 'groupDescription': 'For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANOVA model included the factors treatment, period, sequence, and subject(sequence).', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 8:00h, Day 32/ Day 39 8:00h', 'description': 'Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 8:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population within the placebo patch group; only non-missing values were analyzed.'}, {'type': 'SECONDARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 1 Hour Before Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moxifloxacin Infusion', 'description': 'Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.'}, {'id': 'OG001', 'title': 'Placebo Infusion', 'description': 'Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.84', 'spread': '5.97', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '6.03', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.48', 'ciLowerLimit': '-0.72', 'ciUpperLimit': '1.68', 'estimateComment': 'The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.', 'groupDescription': 'For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANOVA model included the factors treatment, period, sequence, and subject(sequence).', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 9:00h, Day 32/ Day 39 9:00h', 'description': 'Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 9:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population within the placebo patch group; only non-missing values were analyzed.'}, {'type': 'SECONDARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI at Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moxifloxacin Infusion', 'description': 'Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.'}, {'id': 'OG001', 'title': 'Placebo Infusion', 'description': 'Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.21', 'spread': '6.19', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '7.34', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '1.51', 'ciLowerLimit': '0.30', 'ciUpperLimit': '2.73', 'estimateComment': 'The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.', 'groupDescription': 'For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANOVA model included the factors treatment, period, sequence, and subject(sequence).', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 10:00h, Day 32/ Day 39 10:00h', 'description': 'Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 10:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population within the placebo patch group; only non-missing values were analyzed.'}, {'type': 'SECONDARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 1 Hour After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moxifloxacin Infusion', 'description': 'Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.'}, {'id': 'OG001', 'title': 'Placebo Infusion', 'description': 'Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.19', 'spread': '7.49', 'groupId': 'OG000'}, {'value': '3.70', 'spread': '5.72', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '13.50', 'ciLowerLimit': '11.78', 'ciUpperLimit': '15.22', 'estimateComment': 'The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.', 'groupDescription': 'For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANOVA model included the factors treatment, period, sequence, and subject(sequence).', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 11:00h, Day 32/ Day 39 11:00h', 'description': 'Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 11:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population within the placebo patch group; only non-missing values were analyzed.'}, {'type': 'SECONDARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 2 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moxifloxacin Infusion', 'description': 'Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.'}, {'id': 'OG001', 'title': 'Placebo Infusion', 'description': 'Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.44', 'spread': '7.94', 'groupId': 'OG000'}, {'value': '1.42', 'spread': '6.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '11.02', 'ciLowerLimit': '9.12', 'ciUpperLimit': '12.93', 'estimateComment': 'The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.', 'groupDescription': 'For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANOVA model included the factors treatment, period, sequence, and subject(sequence).', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 12:00h, Day 32/ Day 39 12:00h', 'description': 'Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 12:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population within the placebo patch group; only non-missing values were analyzed.'}, {'type': 'SECONDARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 3 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moxifloxacin Infusion', 'description': 'Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.'}, {'id': 'OG001', 'title': 'Placebo Infusion', 'description': 'Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.68', 'spread': '7.35', 'groupId': 'OG000'}, {'value': '1.44', 'spread': '5.91', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '11.30', 'ciLowerLimit': '9.94', 'ciUpperLimit': '12.67', 'estimateComment': 'The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.', 'groupDescription': 'For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANOVA model included the factors treatment, period, sequence, and subject(sequence).', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 13:00h, Day 32/ Day 39 13:00h', 'description': 'Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 13:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population within the placebo patch group; only non-missing values were analyzed.'}, {'type': 'SECONDARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 4 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moxifloxacin Infusion', 'description': 'Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.'}, {'id': 'OG001', 'title': 'Placebo Infusion', 'description': 'Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.48', 'spread': '6.95', 'groupId': 'OG000'}, {'value': '1.28', 'spread': '6.37', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '8.28', 'ciLowerLimit': '6.85', 'ciUpperLimit': '9.70', 'estimateComment': 'The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.', 'groupDescription': 'For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANOVA model included the factors treatment, period, sequence, and subject(sequence).', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 14:00h, Day 32/ Day 39 14:00h', 'description': 'Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 14:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population within the placebo patch group; only non-missing values were analyzed.'}, {'type': 'SECONDARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 5 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moxifloxacin Infusion', 'description': 'Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.'}, {'id': 'OG001', 'title': 'Placebo Infusion', 'description': 'Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.06', 'spread': '6.53', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '5.50', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '9.30', 'ciLowerLimit': '7.57', 'ciUpperLimit': '11.02', 'estimateComment': 'The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.', 'groupDescription': 'For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANOVA model included the factors treatment, period, sequence, and subject(sequence).', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 15:00h, Day 32/ Day 39 15:00h', 'description': 'Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 15:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population within the placebo patch group; only non-missing values were analyzed.'}, {'type': 'SECONDARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 6 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moxifloxacin Infusion', 'description': 'Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.'}, {'id': 'OG001', 'title': 'Placebo Infusion', 'description': 'Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.98', 'spread': '6.74', 'groupId': 'OG000'}, {'value': '1.10', 'spread': '4.93', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '8.87', 'ciLowerLimit': '7.47', 'ciUpperLimit': '10.28', 'estimateComment': 'The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.', 'groupDescription': 'For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANOVA model included the factors treatment, period, sequence, and subject(sequence).', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 16:00h, Day 32/ Day 39 16:00h', 'description': 'Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 16:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population within the placebo patch group; only non-missing values were analyzed.'}, {'type': 'SECONDARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 7 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moxifloxacin Infusion', 'description': 'Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.'}, {'id': 'OG001', 'title': 'Placebo Infusion', 'description': 'Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.97', 'spread': '6.47', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '6.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '8.60', 'ciLowerLimit': '7.25', 'ciUpperLimit': '9.96', 'estimateComment': 'The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.', 'groupDescription': 'For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANOVA model included the factors treatment, period, sequence, and subject(sequence).', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 17:00h, Day 32/ Day 39 17:00h', 'description': 'Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 17:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population within the placebo patch group; only non-missing values were analyzed.'}, {'type': 'SECONDARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 8 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moxifloxacin Infusion', 'description': 'Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.'}, {'id': 'OG001', 'title': 'Placebo Infusion', 'description': 'Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.74', 'spread': '5.84', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '5.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '7.52', 'ciLowerLimit': '6.31', 'ciUpperLimit': '8.72', 'estimateComment': 'The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.', 'groupDescription': 'For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANOVA model included the factors treatment, period, sequence, and subject(sequence).', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 18:00h, Day 32/ Day 39 18:00h', 'description': 'Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 18:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population within the placebo patch group; only non-missing values were analyzed.'}, {'type': 'SECONDARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 9 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moxifloxacin Infusion', 'description': 'Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.'}, {'id': 'OG001', 'title': 'Placebo Infusion', 'description': 'Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.33', 'spread': '6.26', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '5.51', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '7.58', 'ciLowerLimit': '6.21', 'ciUpperLimit': '8.95', 'estimateComment': 'The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.', 'groupDescription': 'For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANOVA model included the factors treatment, period, sequence, and subject(sequence).', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 19:00h, Day 32/ Day 39 19:00h', 'description': 'Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 19:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population within the placebo patch group; only non-missing values were analyzed.'}, {'type': 'SECONDARY', 'title': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 10 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Moxifloxacin Infusion', 'description': 'Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.'}, {'id': 'OG001', 'title': 'Placebo Infusion', 'description': 'Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.34', 'spread': '6.13', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '4.98', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '6.19', 'ciLowerLimit': '4.94', 'ciUpperLimit': '7.45', 'estimateComment': 'The direction of the estimate is Moxifloxacin - Placebo. Mean difference was estimated from the ANOVA model.', 'groupDescription': 'For the analysis of the assay sensitivity, an ANOVA with the factors treatment, period, sequence, and subject(sequence) for comparison of moxifloxacin vs placebo (cross-over comparison) was performed. The point estimates for the difference between placebo and positive control (moxifloxacin) and the respective 95% confidence intervals were calculated.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The ANOVA model included the factors treatment, period, sequence, and subject(sequence).', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2/ Day -1) 20:00h, Day 32/ Day 39 20:00h', 'description': 'Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 20:00h.', 'unitOfMeasure': 'milliseconds [ms]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population within the placebo patch group; only non-missing values were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rotigotine Patch (Infusion: Placebo-Placebo)', 'description': 'Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule. Placebo saline solution 250 mL infused over 1 hour on Day 32 and on Day 39.'}, {'id': 'FG001', 'title': 'Placebo Patch (Infusion: Moxifloxacin-Placebo)', 'description': 'Placebo Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule. Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour on Day 32. Placebo saline solution 250 mL infused over 1 hour on Day 39.'}, {'id': 'FG002', 'title': 'Placebo Patch (Infusion: Placebo-Moxifloxacin)', 'description': 'Placebo Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule. Placebo saline solution 250 mL infused over 1 hour on Day 32. Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour on Day 39.'}], 'periods': [{'title': 'Patch Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'Cross-over Period 1 (Day 32)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Cross-over Period 2 (Day 39)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Within the placebo patch group, subjects were randomized to the sequence of receiving either placebo saline iv solution or moxifloxacin iv solution on Days 32 and 39 in a cross-over design. This treatment was in addition to treatment with the placebo patch. Subjects in the rotigotine patch group received placebo iv solution on Day 32 and Day 39.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rotigotine Patch', 'description': 'Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}, {'id': 'BG001', 'title': 'Placebo Patch', 'description': 'Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.5', 'spread': '10.4', 'groupId': 'BG000'}, {'value': '63.1', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '63.3', 'spread': '10.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Africa', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-17', 'studyFirstSubmitDate': '2006-02-14', 'resultsFirstSubmitDate': '2009-09-09', 'studyFirstSubmitQcDate': '2006-02-14', 'lastUpdatePostDateStruct': {'date': '2014-10-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-02-02', 'studyFirstPostDateStruct': {'date': '2006-02-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-02-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI at Time of Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 20:00h, Day 42 20:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 20:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 1 Hour After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 21:00h, Day 42 21:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 21:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 2 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 22:00h, Day 42 22:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 22:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 3 Hours After Patch Application on Day 42(Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 23:00h, Day 42 23:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 23:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 4 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 00:00h, Day 43 00:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 00:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 5 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 1:00h, Day 43 1:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 1:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 6 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 2:00h, Day 43 2:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 2:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 7 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 3:00h, Day 43 3:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 3:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 8 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 4:00h, Day 43 4:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 4:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 9 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 5:00h, Day 43 5:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 5:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 10 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 6:00h, Day 43 6:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 6:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 11 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 7:00h, Day 43 7:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 7:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 12 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 8:00h, Day 43 8:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 8:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 13 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 9:00h, Day 43 9:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 9:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 14 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 10:00h, Day 43 10:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 10:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 15 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 11:00h, Day 43 11:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 11:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 16 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 12:00h, Day 43 12:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 12:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 17 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 13:00h, Day 43 13:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 13:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 18 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 14:00h, Day 43 14:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 14:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 19 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 15:00h, Day 43 15:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 15:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 20 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 16:00h, Day 43 16:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 16:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 21 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 17:00h, Day 43 17:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 17:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 22 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 18:00h, Day 43 18:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 18:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 23 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 19:00h, Day 43 19:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 19:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTc Based on the QTcI 24 Hours After Patch Application on Day 42 (Rotigotine Dose of 54 mg/Day) (Parallel-group Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 20:00h, Day 43 20:00h', 'description': 'Change in QTcI was analyzed by a parallel-group comparison between rotigotine patch and placebo patch. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). The baseline QTcI value was obtained from the average of the ECG assessment on Day -2 and Day -1. Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 20:00h.'}], 'secondaryOutcomes': [{'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 2 Hours Before Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 8:00h, Day 32/ Day 39 8:00h', 'description': 'Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 8:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 1 Hour Before Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 9:00h, Day 32/ Day 39 9:00h', 'description': 'Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 9:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI at Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 10:00h, Day 32/ Day 39 10:00h', 'description': 'Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 10:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 1 Hour After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 11:00h, Day 32/ Day 39 11:00h', 'description': 'Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 11:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 2 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 12:00h, Day 32/ Day 39 12:00h', 'description': 'Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 12:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 3 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 13:00h, Day 32/ Day 39 13:00h', 'description': 'Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 13:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 4 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 14:00h, Day 32/ Day 39 14:00h', 'description': 'Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 14:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 5 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 15:00h, Day 32/ Day 39 15:00h', 'description': 'Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 15:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 6 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 16:00h, Day 32/ Day 39 16:00h', 'description': 'Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 16:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 7 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 17:00h, Day 32/ Day 39 17:00h', 'description': 'Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 17:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 8 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 18:00h, Day 32/ Day 39 18:00h', 'description': 'Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 18:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 9 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 19:00h, Day 32/ Day 39 19:00h', 'description': 'Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 19:00h.'}, {'measure': 'Time-matched Change From Baseline (Average of Day -2 and Day -1) in QTcI 10 Hours After Start of Infusion on Day 32 or Day 39 (Positive Control) and Respective Day 39 or Day 32 (Corresponding Placebo) (Cross-over Comparison)', 'timeFrame': 'Baseline (Day -2/ Day -1) 20:00h, Day 32/ Day 39 20:00h', 'description': 'Change in QTcI was analyzed by a cross-over comparison between moxifloxacin infusion and placebo infusion. The QT interval refers to the respective time interval in the Electrocardiogram (ECG). The QT interval was corrected for heart rate using an individualized heart rate correction formula including QT/RR curvature optimization (QTcI). Absolute values are presented as unadjusted Mean and Standard Deviation. Baseline and final measures were taken at 20:00h.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["advanced-stage idiopathic Parkinson's disease"], 'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'references': [{'pmid': '18650802', 'type': 'RESULT', 'citation': "Malik M, Andreas JO, Hnatkova K, Hoeckendorff J, Cawello W, Middle M, Horstmann R, Braun M. Thorough QT/QTc study in patients with advanced Parkinson's disease: cardiac safety of rotigotine. Clin Pharmacol Ther. 2008 Nov;84(5):595-603. doi: 10.1038/clpt.2008.143. Epub 2008 Jul 23."}, {'pmid': '22401642', 'type': 'RESULT', 'citation': 'Elshoff JP, Braun M, Andreas JO, Middle M, Cawello W. Steady-state plasma concentration profile of transdermal rotigotine: an integrated analysis of three, open-label, randomized, phase I multiple dose studies. Clin Ther. 2012 Apr;34(4):966-78. doi: 10.1016/j.clinthera.2012.02.008. Epub 2012 Mar 7.'}], 'seeAlsoLinks': [{'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to assess whether rotigotine has an effect on the electrical activity of the heart. Moxifloxacin infusion is used as positive control to assess assay sensitivity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female at least 18 years of age\n* Advanced-stage idiopathic Parkinson's disease requiring treatment with levodopa.\n* Nonchildbearing potential\n\nExclusion Criteria:\n\n* Atypical Parkinson's syndrome(s).\n* History of pallidotomy, thalamotomy, deep brain stimulation, or fetal tissue transplant.\n* Significant tremor or dyskinesias.\n* Severe dysfunction of the autonomic nervous system.\n* History of transient ischemic attack or stroke within the last 12 months.\n* Conduction abnormality or relevant cardiac dysfunction and/or myocardial infarction within last 12 months.\n* History or current condition of additional risk factors for Torsade de Pointes (eg, heart failure, hypokalemia), or a family history of long QT syndrome and/or of Torsade de Pointes.\n* No stable sinus rhythm: more than 20 ectopics/h.\n* Any other clinically relevant ECG abnormality.\n* History or current condition of epilepsy and/or seizures.\n* History or current condition of atopic or eczematous dermatitis, psoriasis, or another active skin disease.\n* History or current condition of symptomatic orthostatic hypotension.\n* History or current condition of significant skin hypersensitivity to adhesives or other transdermal products or recent unresolved contact dermatitis.\n* History of glucose 6-phosphate dehydrogenase deficiency.\n* History of tendonitis or tendon rupture with quinolone antibiotics.\n* Renal or hepatic dysfunction.\n* Treatment with dopamine agonists, MAO A inhibitors, reserpine, or alpha-methyldopa\n* Therapy known to produce a nontrivial prolongation of the QT interval."}, 'identificationModule': {'nctId': 'NCT00292227', 'briefTitle': "Cardiac Effects of Rotigotine Transdermal System in Subjects With Advanced-stage Idiopathic Parkinson's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': "Double-blind, Randomized, Placebo- and Positive-controlled, Parallel-group Trial to Assess the Potential Electrocardiographic Effects of Rotigotine Transdermal System up to 120 cm2/54.0 mg/Day in Subjects With Advanced-stage Idiopathic Parkinson's Disease: A Thorough QT/QTc Trial.", 'orgStudyIdInfo': {'id': 'SP0864'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rotigotine', 'description': 'Rotigotine Patch', 'interventionNames': ['Drug: Rotigotine', 'Other: Placebo infusion']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo patch', 'interventionNames': ['Other: Placebo', 'Drug: Moxifloxacin infusion', 'Other: Placebo infusion']}], 'interventions': [{'name': 'Rotigotine', 'type': 'DRUG', 'otherNames': ['Neupro'], 'description': 'Rotigotine patch applied once daily for a 24-hour period.\n\nRotigotine dose schedule (patch application days):\n\nDay 1 through Day 7: 9.0 mg/day; Day 8 through Day 14: 18.0 mg/day; Day 15 through Day 21: 27.0 mg/day; Day 22 through Day 28: 36.0 mg/day; Day 29 through Day 35: 45.0 mg/day; Day 36 through Day 42: 54.0 mg/day; Day 43 through Day 44: 45.0 mg/day; Day 45 through Day 46: 36.0 mg/day; Day 47 through Day 48: 27.0 mg/day; Day 49 through Day 50: 18.0 mg/day; Day 51 through Day 52: 9.0 mg/day;', 'armGroupLabels': ['Rotigotine']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo patch applied once daily for a 24-hour period. Size and number of patches matching to rotigotine dose schedule (patch application days):\n\nDay 1 through Day 7: 9.0 mg/day; Day 8 through Day 14: 18.0 mg/day; Day 15 through Day 21: 27.0 mg/day; Day 22 through Day 28: 36.0 mg/day; Day 29 through Day 35: 45.0 mg/day; Day 36 through Day 42: 54.0 mg/day; Day 43 through Day 44: 45.0 mg/day; Day 45 through Day 46: 36.0 mg/day; Day 47 through Day 48: 27.0 mg/day; Day 49 through Day 50: 18.0 mg/day; Day 51 through Day 52: 9.0 mg/day;', 'armGroupLabels': ['Placebo']}, {'name': 'Moxifloxacin infusion', 'type': 'DRUG', 'description': 'Moxifloxacin 400 mg/250 mL iv solution infused over 1h once either on Day 32 or on Day 39', 'armGroupLabels': ['Placebo']}, {'name': 'Placebo infusion', 'type': 'OTHER', 'description': 'Placebo saline solution 250 mL infused over 1h once either on Day 32 or on Day 39', 'armGroupLabels': ['Placebo']}, {'name': 'Placebo infusion', 'type': 'OTHER', 'description': 'Placebo saline solution 250 mL infused over 1h once on both Day 32 and on Day 39', 'armGroupLabels': ['Rotigotine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bloemfontein', 'country': 'South Africa', 'facility': 'Farmovs-Parexel (Pty) Ltd', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}, {'city': 'George', 'country': 'South Africa', 'facility': 'Qdot, a division of Parexel International DA (Pty) Ltd.', 'geoPoint': {'lat': -33.963, 'lon': 22.46173}}], 'overallOfficials': [{'name': 'UCB Clinical Trial Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': '+1 877 822 9493 (UCB)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}