Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-01-04 @ 9:25 AM
Study NCT ID:
NCT00623103
Status:
COMPLETED
Last Update Posted:
2011-11-28
First Post:
2008-02-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068836', 'term': 'Rivastigmine'}], 'ancestors': [{'id': 'D048448', 'term': 'Phenylcarbamates'}, {'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Exelon Capsule', 'description': 'Exelon Capsule', 'otherNumAtRisk': 294, 'otherNumAffected': 239, 'seriousNumAtRisk': 294, 'seriousNumAffected': 87}, {'id': 'EG001', 'title': 'Exelon Patch', 'description': 'Exelon Patch', 'otherNumAtRisk': 288, 'otherNumAffected': 215, 'seriousNumAtRisk': 288, 'seriousNumAffected': 83}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 117}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Application site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 40}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 49}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bradykinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'On and off phenomenon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Parkinsonian gait', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Parkinsonian rest tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 26}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 22}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 21}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 22}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 21}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hallucination, visual', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 16}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 23}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 10}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 17}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cardiac valve sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Sinus arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Inguinal hernia strangulated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Mesenteric occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Salivary hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Complication of device insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Device failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cystitis klebsiella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Freezing phenomenon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypokinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Lacunar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Monoparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'On and off phenomenon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': "Parkinson's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Parkinsonian gait', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Parkinsonian rest tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Psychomotor hyperactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Psychomotor skills impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Quadriplegia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Delusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hallucination, visual', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Psychotic disorder due to a general medical condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bladder trabeculation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Calculus bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Micturition urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urinary bladder polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Prostatic obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Brain hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 294, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 288, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivastigmine Capsule', 'description': 'Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.'}, {'id': 'OG001', 'title': 'Rivastigmine Patch', 'description': 'Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm\\^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm\\^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm\\^2 patch or the highest well tolerated dose was maintained until week 76.'}], 'classes': [{'title': 'Tremor', 'categories': [{'measurements': [{'value': '24.5', 'groupId': 'OG000', 'lowerLimit': '19.7', 'upperLimit': '29.8'}, {'value': '9.7', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': '13.7'}]}]}, {'title': 'Muscle Rigidity', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '7.0'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '8.4'}]}]}, {'title': 'Bradykinesia', 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '8.3'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '9.7'}]}]}, {'title': 'Fall', 'categories': [{'measurements': [{'value': '17.0', 'groupId': 'OG000', 'lowerLimit': '12.9', 'upperLimit': '21.8'}, {'value': '20.1', 'groupId': 'OG001', 'lowerLimit': '15.7', 'upperLimit': '25.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '76 Weeks', 'description': 'The AEs were summarized by presenting the number and percentage of patients having any of the 4 AEs or discontinued due to any of the 4 predefined AEs (tremor, muscle rigidity, bradykinesia, and fall)in each treatment group. The 95% CIs associated with the rates were also presented.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population consisted of all participants who received at least 1 dose of study drug and had 1 post-baseline safety measurement. Participants with observation at 76 weeks were included in this analysis.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Study Drug Discontinuations Due to Predefined AEs That Are Due, or Potentially Due, to Worsening of PD Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivastigmine Capsule', 'description': 'Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.'}, {'id': 'OG001', 'title': 'Rivastigmine Patch', 'description': 'Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm\\^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm\\^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm\\^2 patch or the highest well tolerated dose was maintained until week 76.'}], 'classes': [{'title': 'Tremor', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '4.8'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '2.5'}]}]}, {'title': 'Muscle Rigidity', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.9'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.9'}]}]}, {'title': 'Bradykinesia', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '3.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}, {'title': 'Fall', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '3.0'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '3.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '76 Weeks', 'description': 'The discontinuations due to these AEs were summarized by presenting the number and percentage of patients having any of the 4 AEs or discontinued due to any of the 4 predefined AEs (tremor, muscle rigidity, bradykinesia, and fall) in each treatment group. The 95% CIs associated with these rates were also presented.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population consisted of all participants who received at least 1 dose of study drug and had 1 post-baseline safety measurement. Participants with observation at 76 weeks were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination Scores at Weeks 8, 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivastigmine Capsule', 'description': 'Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.'}, {'id': 'OG001', 'title': 'Rivastigmine Patch', 'description': 'Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm\\^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm\\^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm\\^2 patch or the highest well tolerated dose was maintained until week 76.'}], 'classes': [{'title': 'Week 8 (n=276,277)', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '6.99', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '7.05', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=254,252)', 'categories': [{'measurements': [{'value': '0.5', 'spread': '7.72', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '7.44', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (n=229,237)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '8.19', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '7.90', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=203,206)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '8.66', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '9.57', 'groupId': 'OG001'}]}]}, {'title': 'Week 76 (n=183,175)', 'categories': [{'measurements': [{'value': '2.1', 'spread': '9.98', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '9.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Weeks 8, 16, 24, 52 and 76', 'description': "Unified Parkinson Disease Rating Scale (UPDRS) is a 6 part Parkinson's disease specific rating scale that estimates clinical function taking into consideration both disability (functional deficits) and impairment (objective clinical signs). Part III records the motor examination in Items 18-31 rated on a scale of 0 to 4 with (0 being absent/ normal and 4 being the worse) for a total possible score of 0 to 56.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all participants who received at least 1 dose of study drug and had 1 post-baseline safety measurement. "n" in each of the categories is the number of participants at each time point with non-missing baseline and post-baseline measurements.'}, {'type': 'SECONDARY', 'title': 'Change in Mattis Dementia Rating Scale (Mattis DRS-2) Scores at Weeks 16, 24, 52 and 76 Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivastigmine Capsule', 'description': 'Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.'}, {'id': 'OG001', 'title': 'Rivastigmine Patch', 'description': 'Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm\\^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm\\^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm\\^2 patch or the highest well tolerated dose was maintained until week 76.'}], 'classes': [{'title': 'Week 16', 'categories': [{'measurements': [{'value': '5.4', 'spread': '11.98', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '11.53', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '6.5', 'spread': '12.98', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '12.85', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '4.6', 'spread': '13.62', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '15.07', 'groupId': 'OG001'}]}]}, {'title': 'Week 76', 'categories': [{'measurements': [{'value': '3.9', 'spread': '16.82', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '17.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Weeks 16, 24, 52 and 76', 'description': 'Mattis DRS-2 is a measure of cognitive status. The total score is the sum of 5 subscale scores: Attention \\[0-37\\], Initiation/Perservation \\[0-37\\] (performing alternating movements), Construction \\[0-6\\] (copying designs), Conceptualization \\[0-39\\] (similarities) and Memory \\[0-25\\] (sentence recall, design recognition)for a total possible score of 0-144. Higher score is reflective of better cognitive function, lower scores associated with more pronounced cognitive deficit. The change from baseline was calculated such that a positive number indicates an improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF)'}, {'type': 'SECONDARY', 'title': 'Change in Ten Point Clock Test (TPCT) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivastigmine Capsule', 'description': 'Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.'}, {'id': 'OG001', 'title': 'Rivastigmine Patch', 'description': 'Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm\\^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm\\^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm\\^2 patch or the highest well tolerated dose was maintained until week 76.'}], 'classes': [{'title': 'Week 16', 'categories': [{'measurements': [{'value': '0.5', 'spread': '2.75', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '3.02', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '0.6', 'spread': '3.18', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '3.40', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.97', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '3.33', 'groupId': 'OG001'}]}]}, {'title': 'Week 76', 'categories': [{'measurements': [{'value': '0.0', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '3.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Weeks 16, 24, 52 and 76', 'description': 'The Ten Point Clock Test measures executive functioning and visuospatial skills. Participants are asked to put numbers on the face of a clock and then make the clock read 10 minutes after 11. Points are awarded on a scale of 0 to 10 for spacing of specific numbers and the positions of the hands. The change from baseline was calculated such that a positive number indicates improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF)'}, {'type': 'SECONDARY', 'title': 'Change in Neuropsychiatric Inventory-10 (NPI-10) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivastigmine Capsule', 'description': 'Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.'}, {'id': 'OG001', 'title': 'Rivastigmine Patch', 'description': 'Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm\\^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm\\^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm\\^2 patch or the highest well tolerated dose was maintained until week 76.'}], 'classes': [{'title': 'Week 16', 'categories': [{'measurements': [{'value': '-3.3', 'spread': '9.75', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '10.89', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '-2.6', 'spread': '10.31', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '10.27', 'groupId': 'OG001'}]}]}, {'title': 'Week 52', 'categories': [{'measurements': [{'value': '-1.7', 'spread': '11.40', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '11.26', 'groupId': 'OG001'}]}]}, {'title': 'Week 76', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '11.22', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '12.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 16, 24, 52 and 76 (or early discontinuation)', 'description': 'The parameter for analysis was the change from baseline of total score of 10 items on the NPI scale (NPI-10). The total score is a sum of the 10 domains, where the score for a domain is defined as the product of frequency (range: 1-4) and severity (range: 1-3). Each domain has a maximum score of 12 and all domains were equally weighted for total score(thus the range for the total score is 0 to 120 with 0 being completely healthy to 120 which is the worse score patient can get). The change from baseline was calculated such that a negative number indicates an improvement (symptom reduction).', 'unitOfMeasure': 'Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF)'}, {'type': 'SECONDARY', 'title': "Change in Alzheimer's Disease Cooperative Study-Activities Of Daily Living (ADCS-ADL) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline", 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivastigmine Capsule', 'description': 'Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.'}, {'id': 'OG001', 'title': 'Rivastigmine Patch', 'description': 'Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm\\^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm\\^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm\\^2 patch or the highest well tolerated dose was maintained until week 76.'}], 'classes': [{'title': 'Week 16 (n=273, 270)', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '9.60', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '10.38', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (n=273,270)', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '10.12', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '10.91', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=273,270)', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '11.13', 'groupId': 'OG000'}, {'value': '-5.4', 'spread': '13.57', 'groupId': 'OG001'}]}]}, {'title': 'Week 76 (n=273, 270)', 'categories': [{'measurements': [{'value': '-4.4', 'spread': '13.13', 'groupId': 'OG000'}, {'value': '-7.8', 'spread': '15.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Week 16, 24, 52 and 76 (or early discontinuation)', 'description': "The 23 item caregiver-based ADL scale of the dementia Alzheimer's disease Cooperative Study-Activities of Daily Living (ADCS-ADL) was used for analysis. This is a caregiver rated questionnaire of 23 items, with possible scores over a range of 0-78, where 78 denote full functioning with no impairment. The total score was derived by adding up the item scores of the 23 items.\n\nThe change from baseline was calculated such that a positive change indicates an improvement.", 'unitOfMeasure': 'Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population which included all patients who received at least 1 dose of study drug and had at least 1 pre- and post-baseline assessment for 1 of the efficacy variables. Last observation carried forward. (LOCF).'}, {'type': 'SECONDARY', 'title': 'UPDRS Part V Stage (Modified Hoehn and Yahr Staging)at Baseline, Week 8,16,24,52 and 76 (or Early Discontinuation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivastigmine Capsule', 'description': 'Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.'}, {'id': 'OG001', 'title': 'Rivastigmine Patch', 'description': 'Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm\\^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm\\^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm\\^2 patch or the highest well tolerated dose was maintained until week 76.'}], 'classes': [{'title': 'Baseline (n = 294,288)', 'categories': [{'measurements': [{'value': '2.7', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '0.70', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (n=17,18)', 'categories': [{'measurements': [{'value': '2.6', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '1.05', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=254,252)', 'categories': [{'measurements': [{'value': '2.8', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (229, 236)', 'categories': [{'measurements': [{'value': '2.7', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': 'Week 52 (n=202,208)', 'categories': [{'measurements': [{'value': '2.8', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '0.69', 'groupId': 'OG001'}]}]}, {'title': 'Week 76 (n=184, 175)', 'categories': [{'measurements': [{'value': '2.8', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '0.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Week 8, 16, 24, 52 and 76 (or early discontinuation)', 'description': "Unified Parkinson Disease Rating Scale (UPDRS) is a 6 part Parkinson's disease specific rating scale that estimates clinical function taking into consideration both disability (functional deficits) and impairment (objective clinical signs). UPDRS Part V is assessed by the modified Hoehn and Yahr Staging Scale. The scale ranges from 0 (no signs of disease) to 5 (wheelchair bound or bedridden unless aided).", 'unitOfMeasure': 'Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population consisted of all patients who have received at least one dose of study drug and have had at least 1 safety measurement after baseline. n=indicates patients with observation during different timepoints.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rivastigmine Capsule', 'description': 'Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.'}, {'id': 'FG001', 'title': 'Rivastigmine Patch', 'description': 'Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm\\^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm\\^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm\\^2 patch or the highest well tolerated dose was maintained until week 76.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '295'}, {'groupId': 'FG001', 'numSubjects': '288'}]}, {'type': 'Safety Set: Received Study Drug', 'achievements': [{'comment': 'One randomized participant did not receive study drug and was not included in the Safety set.', 'groupId': 'FG000', 'numSubjects': '294'}, {'groupId': 'FG001', 'numSubjects': '288'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '184'}, {'groupId': 'FG001', 'numSubjects': '175'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '113'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'Unsatisfactory therapeutic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'BG000'}, {'value': '288', 'groupId': 'BG001'}, {'value': '583', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rivastigmine Capsule', 'description': 'Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally0. The 12 mg/day dose or the highest dose tolerated was maintained until week 76.'}, {'id': 'BG001', 'title': 'Rivastigmine Patch', 'description': 'Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm\\^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm\\^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm\\^2 patch or the highest well tolerated dose was maintained until week 76.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '72.35', 'spread': '6.295', 'groupId': 'BG000'}, {'value': '72.26', 'spread': '6.352', 'groupId': 'BG001'}, {'value': '72.31', 'spread': '6.318', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '191', 'groupId': 'BG001'}, {'value': '398', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 583}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'lastUpdateSubmitDate': '2011-10-19', 'studyFirstSubmitDate': '2008-02-14', 'resultsFirstSubmitDate': '2011-10-19', 'studyFirstSubmitQcDate': '2008-02-22', 'lastUpdatePostDateStruct': {'date': '2011-11-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-10-19', 'studyFirstPostDateStruct': {'date': '2008-02-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Adverse Events (AEs) Due, or Potentially Due, to Worsening of Parkinson Disease (PD) Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall)', 'timeFrame': '76 Weeks', 'description': 'The AEs were summarized by presenting the number and percentage of patients having any of the 4 AEs or discontinued due to any of the 4 predefined AEs (tremor, muscle rigidity, bradykinesia, and fall)in each treatment group. The 95% CIs associated with the rates were also presented.'}, {'measure': 'Percentage of Participants With Study Drug Discontinuations Due to Predefined AEs That Are Due, or Potentially Due, to Worsening of PD Motor Symptoms (Tremor, Muscle Rigidity, Bradykinesia, Fall)', 'timeFrame': '76 Weeks', 'description': 'The discontinuations due to these AEs were summarized by presenting the number and percentage of patients having any of the 4 AEs or discontinued due to any of the 4 predefined AEs (tremor, muscle rigidity, bradykinesia, and fall) in each treatment group. The 95% CIs associated with these rates were also presented.'}], 'secondaryOutcomes': [{'measure': 'Change in Unified Parkinson Disease Rating Scale (UPDRS) Part III Motor Examination Scores at Weeks 8, 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline', 'timeFrame': 'From Baseline to Weeks 8, 16, 24, 52 and 76', 'description': "Unified Parkinson Disease Rating Scale (UPDRS) is a 6 part Parkinson's disease specific rating scale that estimates clinical function taking into consideration both disability (functional deficits) and impairment (objective clinical signs). Part III records the motor examination in Items 18-31 rated on a scale of 0 to 4 with (0 being absent/ normal and 4 being the worse) for a total possible score of 0 to 56."}, {'measure': 'Change in Mattis Dementia Rating Scale (Mattis DRS-2) Scores at Weeks 16, 24, 52 and 76 Compared to Baseline', 'timeFrame': 'From Baseline to Weeks 16, 24, 52 and 76', 'description': 'Mattis DRS-2 is a measure of cognitive status. The total score is the sum of 5 subscale scores: Attention \\[0-37\\], Initiation/Perservation \\[0-37\\] (performing alternating movements), Construction \\[0-6\\] (copying designs), Conceptualization \\[0-39\\] (similarities) and Memory \\[0-25\\] (sentence recall, design recognition)for a total possible score of 0-144. Higher score is reflective of better cognitive function, lower scores associated with more pronounced cognitive deficit. The change from baseline was calculated such that a positive number indicates an improvement.'}, {'measure': 'Change in Ten Point Clock Test (TPCT) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline', 'timeFrame': 'From Baseline to Weeks 16, 24, 52 and 76', 'description': 'The Ten Point Clock Test measures executive functioning and visuospatial skills. Participants are asked to put numbers on the face of a clock and then make the clock read 10 minutes after 11. Points are awarded on a scale of 0 to 10 for spacing of specific numbers and the positions of the hands. The change from baseline was calculated such that a positive number indicates improvement.'}, {'measure': 'Change in Neuropsychiatric Inventory-10 (NPI-10) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline', 'timeFrame': 'At Week 16, 24, 52 and 76 (or early discontinuation)', 'description': 'The parameter for analysis was the change from baseline of total score of 10 items on the NPI scale (NPI-10). The total score is a sum of the 10 domains, where the score for a domain is defined as the product of frequency (range: 1-4) and severity (range: 1-3). Each domain has a maximum score of 12 and all domains were equally weighted for total score(thus the range for the total score is 0 to 120 with 0 being completely healthy to 120 which is the worse score patient can get). The change from baseline was calculated such that a negative number indicates an improvement (symptom reduction).'}, {'measure': "Change in Alzheimer's Disease Cooperative Study-Activities Of Daily Living (ADCS-ADL) Scores at Weeks 16, 24, 52 and 76 (or Early Discontinuation) Compared to Baseline", 'timeFrame': 'From Baseline to Week 16, 24, 52 and 76 (or early discontinuation)', 'description': "The 23 item caregiver-based ADL scale of the dementia Alzheimer's disease Cooperative Study-Activities of Daily Living (ADCS-ADL) was used for analysis. This is a caregiver rated questionnaire of 23 items, with possible scores over a range of 0-78, where 78 denote full functioning with no impairment. The total score was derived by adding up the item scores of the 23 items.\n\nThe change from baseline was calculated such that a positive change indicates an improvement."}, {'measure': 'UPDRS Part V Stage (Modified Hoehn and Yahr Staging)at Baseline, Week 8,16,24,52 and 76 (or Early Discontinuation)', 'timeFrame': 'From Baseline to Week 8, 16, 24, 52 and 76 (or early discontinuation)', 'description': "Unified Parkinson Disease Rating Scale (UPDRS) is a 6 part Parkinson's disease specific rating scale that estimates clinical function taking into consideration both disability (functional deficits) and impairment (objective clinical signs). UPDRS Part V is assessed by the modified Hoehn and Yahr Staging Scale. The scale ranges from 0 (no signs of disease) to 5 (wheelchair bound or bedridden unless aided)."}]}, 'conditionsModule': {'keywords': ["Parkinson's disease dementia", 'cholinesterase inhibitor', 'rivastigmine'], 'conditions': ["Parkinson's Disease Dementia"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to provide long-term safety data for rivastigmine capsule and transdermal patch treatments, in particular the effect of rivastigmine on worsening of the underlying motor symptoms of Parkinson's Disease (PD), in patients with mild to moderately severe dementia associated with PD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of idiopathic Parkinson\'s disease, according to the UK Parkinson\'s disease Society Brain Bank criteria\n* Diagnosis of Parkinson\'s disease dementia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, with onset of symptoms of dementia at least 2 years following the first diagnosis of idiopathic Parkinson\'s disease\n* Mini Mental State Examination score of ≥10 and ≤ 26 (at Screening Visit only)\n\nExclusion Criteria:\n\n* An advanced, severe, or unstable disease of any type that may interfere with the primary and secondary variable evaluations\n* A score of 5 (wheelchair bound or bedridden) in the "on"-state on the Modified Hoehn and Yahr Staging (UPDRS Part V)\n* A current diagnosis of any primary neurodegenerative disorder other than idiopathic PD\n* A current diagnosis of any treatable dementia (hypothyroidism, syphilis, vitamin B12 or folate deficiency) that is verified by the investigator to be the cause of dementia.\n* A current diagnosis of probably vascular dementia according to the National Institute of Neurological Disorders and Stroke and the Association International pour la Recherche et l\'Enseignement en Neurosciences (NINDS-AIREN) criteria\n* A current diagnosis of a major depressive episode according to DSM-IV criteria\n* A history of stereotaxic brain surgery for Parkinson\'s disease\n* A known exaggerated pharmacological sensitivity or hypersensitivity to drugs similar to rivastigmine or to other cholinergic compounds\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00623103', 'briefTitle': "Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': "A 76-week Prospective, Open-label, Multicenter Study to Evaluate the Long-term Effect of Rivastigmine Capsule and Transdermal Patch on Worsening of the Underlying Motor Symptoms of PD in Patients With Mild to Moderately Severe Dementia Associated With Parkinson's Disease (PDD)", 'orgStudyIdInfo': {'id': 'CENA713B2315'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rivastigmine capsule', 'description': 'Rivastigmine capsules starting at a total dose of 3 mg/day (1.5 mg twice daily orally) titrated up in 3 mg/day increments every 4 weeks to a final dose of 12 mg/day (6 mg twice daily orally). The 12 mg/day dose or the highest dose tolerated was maintained until week 76.', 'interventionNames': ['Drug: Rivastigmine capsule']}, {'type': 'EXPERIMENTAL', 'label': 'Rivastigmine patch', 'description': 'Rivastigmine patch once a day in the morning, worn for 24 hours, starting at 5 cm\\^2 (delivering 4.6 mg rivastigmine over a 24 hour period) for 4 weeks then titrated up to 10 cm\\^2 daily (delivering 9.5 mg rivastigmine over a 24 hour period). The 10 cm\\^2 patch or the highest well tolerated dose was maintained until week 76.', 'interventionNames': ['Drug: Rivastigmine transdermal patch']}], 'interventions': [{'name': 'Rivastigmine capsule', 'type': 'DRUG', 'otherNames': ['Exelon®'], 'description': 'Rivastigmine capsules orally twice a day. Target dose 12 mg/day.', 'armGroupLabels': ['Rivastigmine capsule']}, {'name': 'Rivastigmine transdermal patch', 'type': 'DRUG', 'otherNames': ['Exelon®'], 'description': 'Rivastigmine patch once a day in the morning, worn for 24 hours. 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