Viewing Study NCT00948766

Home

Certify Doc

Genes

Clinical Trials

CompTox

DrugMatrix

Open Targets

Products

Support

Bugs

Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 4:37 PM

Ignite Modification Date: 2025-12-28 @ 7:10 AM

Study NCT ID: NCT00948766

Status: COMPLETED

Last Update Posted: 2013-08-28

First Post: 2009-07-28

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Effects of Rivastigmine Patch on Activities of Daily Living and Cognition in Patients With Severe Dementia of the Alzheimer's Type (ACTION) (Study Protocol CENA713DUS44, NCT00948766) and a 24 Week Open-label Extension to Study CENA713DUS44

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, '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 (ie, data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were reported from randomization in the core study through the end of the extension study (48 weeks).', 'description': 'Safety set: All patients who received at least 1 dose of study medication and had at least 1 safety assessment after baseline. One patient in each treatment group did not receive study medication and were not included in the safety set.', 'eventGroups': [{'id': 'EG000', 'title': 'Core Study: Rivastigmine 13.3 mg/24 h Transdermal Patch', 'description': 'Patients received rivastigmine 13.3 mg/24 h (15 cm\\^2).', 'otherNumAtRisk': 355, 'otherNumAffected': 216, 'seriousNumAtRisk': 355, 'seriousNumAffected': 82}, {'id': 'EG001', 'title': 'Core Study: Rivastigmine 4.6 mg/24 h Transdermal Patch', 'description': 'Patients received rivastigmine 4.6 mg/24 h (5 cm\\^2).', 'otherNumAtRisk': 359, 'otherNumAffected': 210, 'seriousNumAtRisk': 359, 'seriousNumAffected': 74}, {'id': 'EG002', 'title': 'Extension Study: Rivastigmine 13.3 mg/24 h Transdermal Patch', 'description': 'Patients received rivastigmine 13.3 mg/24 h (15 cm\\^2).', 'otherNumAtRisk': 396, 'otherNumAffected': 248, 'seriousNumAtRisk': 396, 'seriousNumAffected': 79}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Application site dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 43}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Application site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 52}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 58}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 42}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 47}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 58}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 19}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 18}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 16}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 30}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 21}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bundle branch block left', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diverticulum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Faecaloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bile duct obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Biliary dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Intestinal gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Kidney infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Back injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Chemical poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fractured sacrum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Incorrect dose administered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Jaw fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pubis fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Skull fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Ulna fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Blood pressure systolic decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cardiac enzymes increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Electrocardiogram T wave inversion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Colon cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Coordination abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': "Dementia Alzheimer's type", 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dysstasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Grand mal convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hepatic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypokinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Mental impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pneumocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Unresponsive to stimuli', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'VIIth nerve paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Mutism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Psychotic disorder due to a general medical condition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Stress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Acute prerenal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Azotaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rectocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Scrotal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pulmonary cavitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cystopexy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hysterectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bloody discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 355, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 359, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 396, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Core Study: Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living-Severe Impairment Version (ADCS-ADL-SIV) Score at Week 24", 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivastigmine 13.3 mg/24 h Transdermal Patch', 'description': 'Patients received rivastigmine 13.3 mg/24 h (15 cm\\^2).'}, {'id': 'OG001', 'title': 'Rivastigmine 4.6 mg/24 h Transdermal Patch', 'description': 'Patients received rivastigmine 4.6 mg/24 h (5 cm\\^2).'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.6', 'spread': '6.82', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '7.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the core study to Week 24 of the core study', 'description': 'The ADCS-ADL-SIV is designed to assess the patient\'s performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, and making judgments and decisions. For each of the 19 questions in the ADCS-ADL-SIV, there was either a forced choice of best response or a "yes" or "no" question with additional sub-questions. Responses for each item were obtained from the caregiver through an interview. Higher numbered scores and answers of "yes" reflected a more self-sufficient individual. The total score was calculated as the sum of all items and sub-questions and ranged from 0 to 54. A higher total score represented a higher functioning patient. A positive change score indicates improvement.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set: All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline measurement of the co-primary efficacy variables. Only patients with available data were included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Core Study: Change From Baseline in the Severity Impairment Battery (SIB) Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'OG000'}, {'value': '316', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivastigmine 13.3 mg/24 h Transdermal Patch', 'description': 'Patients received rivastigmine 13.3 mg/24 h (15 cm\\^2).'}, {'id': 'OG001', 'title': 'Rivastigmine 4.6 mg/24 h Transdermal Patch', 'description': 'Patients received rivastigmine 4.6 mg/24 h (5 cm\\^2).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '13.54', 'groupId': 'OG000'}, {'value': '-6.4', 'spread': '14.01', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the core study to Week 24 of the core study', 'description': 'The SIB is a 40-item scale developed for the evaluation of the severity of cognitive dysfunction in more advanced Alzheimer Disease patients. The domains assessed included social interaction, memory, language, attention, orientation, praxis, visuo-spatial ability, construction, and orienting to name. The items of the SIB were developed as simple 1-step commands which are presented by a trained rater with gestural cues and repeated if necessary. The SIB was scored from 0 to 100, with higher scores reflecting higher levels of cognitive ability. A positive change score indicates improvement.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set: All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline measurement of the co-primary efficacy variables. Only patients with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': "Core Study: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Score at Week 24", 'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivastigmine 13.3 mg/24 h Transdermal Patch', 'description': 'Patients received rivastigmine 13.3 mg/24 h (15 cm\\^2).'}, {'id': 'OG001', 'title': 'Rivastigmine 4.6 mg/24 h Transdermal Patch', 'description': 'Patients received rivastigmine 4.6 mg/24 h (5 cm\\^2).'}], 'classes': [{'title': 'Marked improvement', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Moderate improvement', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}, {'value': '3.5', 'groupId': 'OG001'}]}]}, {'title': 'Minimal improvement', 'categories': [{'measurements': [{'value': '20.1', 'groupId': 'OG000'}, {'value': '11.4', 'groupId': 'OG001'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '34.2', 'groupId': 'OG000'}, {'value': '29.2', 'groupId': 'OG001'}]}]}, {'title': 'Minimal worsening', 'categories': [{'measurements': [{'value': '24.3', 'groupId': 'OG000'}, {'value': '31.4', 'groupId': 'OG001'}]}]}, {'title': 'Moderate worsening', 'categories': [{'measurements': [{'value': '14.1', 'groupId': 'OG000'}, {'value': '19.0', 'groupId': 'OG001'}]}]}, {'title': 'Marked worsening', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}, {'value': '4.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline of the core study to Week 24 of the core study', 'description': "The ADCS-CGIC assesses the clinical meaningfulness of a treatment based on the clinician's rating of change. The rating is provided by a trained clinician or psychometrician blinded to the patient's treatment. The rater interviewed the patient and caregiver separately at Baseline using a worksheet that provided space for notes and comments. At baseline, raters had access to all of the patient's available records and evaluations. The rater used a similar worksheet at follow-up visits, and referred to the baseline worksheet prior to making a rating of change. The worksheets were divided into 3 domains: mental/cognitive state, behavior, and functioning. Change ratings were based on a 7-point scale: Marked (1), moderate (2), and minimal improvement (3), no change (4), and marked (5), moderate (6), and minimal worsening (7). The percentage of patients in each of the 7 categories is reported.", 'unitOfMeasure': 'Percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set: All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline measurement of the co-primary efficacy variables. Only patients with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Core Study: Change From Baseline in the Neuropsychiatric Inventory (NPI-12) Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'OG000'}, {'value': '313', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivastigmine 13.3 mg/24 h Transdermal Patch', 'description': 'Patients received rivastigmine 13.3 mg/24 h (15 cm\\^2).'}, {'id': 'OG001', 'title': 'Rivastigmine 4.6 mg/24 h Transdermal Patch', 'description': 'Patients received rivastigmine 4.6 mg/24 h (5 cm\\^2).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'spread': '14.01', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '16.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the core study to Week 24 of the core study', 'description': 'The NPI-12 assesses a wide range of behaviors encountered in patients with dementia to provide a means of distinguishing the frequency and severity of behavioral changes over time. Ten behavioral and 2 neurovegetative domains were evaluated in an interview with the caregiver given by a mental health professional. The scale included both frequency and severity ratings of each domain as well as a composite domain score (frequency x severity). The sum of the composite scores for the 12 domains yielded the NPI-12 total score. The NPI-12 was scored from 0 to 144, with lower scores reflecting improvement in psychiatric behavior. A negative change score indicates improvement.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set: All randomized patients who received at least 1 dose of study medication and had at least 1 post-baseline measurement of the co-primary efficacy variables. Only patients with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': "Extension Study: Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living-Severe Impairment Version (ADCS-ADL-SIV) Score at Week 24", 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivastigmine 13.3 mg/24 h Transdermal Patch', 'description': 'Patients received rivastigmine 13.3 mg/24 h (15 cm\\^2).'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.3', 'spread': '8.37', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the core study to Week 24 of the extension study', 'description': 'The ADCS-ADL-SIV is designed to assess the patient\'s performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, and making judgments and decisions. For each of the 19 questions in the ADCS-ADL-SIV, there was either a forced choice of best response or a "yes" or "no" question with additional sub-questions. Responses for each item were obtained from the caregiver through an interview. Higher numbered scores and answers of "yes" reflected a more self-sufficient individual. The total score was calculated as the sum of all items and sub-questions and ranged from 0 to 54. A higher total score represented a higher functioning patient. A positive change score indicates improvement.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set: All patients who received at least 1 application of study medication and had at least 1 efficacy assessment in the extension study. Only patients with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Extension Study: Change From Baseline in the Severity Impairment Battery (SIB) Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivastigmine 13.3 mg/24 h Transdermal Patch', 'description': 'Patients received rivastigmine 13.3 mg/24 h (15 cm\\^2).'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.9', 'spread': '16.72', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the core study to Week 24 of the extension study', 'description': 'The SIB is a 40-item scale developed for the evaluation of the severity of cognitive dysfunction in more advanced Alzheimer Disease patients. The domains assessed included social interaction, memory, language, attention, orientation, praxis, visuo-spatial ability, construction, and orienting to name. The items of the SIB were developed as simple 1-step commands which are presented by a trained rater with gestural cues and repeated if necessary. The SIB was scored from 0 to 100, with higher scores reflecting higher levels of cognitive ability. A positive change score indicates improvement.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set: All patients who received at least 1 application of study medication and had at least 1 efficacy assessment in the extension study. Only patients with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': "Extension Study: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Score at Week 24", 'denoms': [{'units': 'Participants', 'counts': [{'value': '381', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rivastigmine 13.3 mg/24 h Transdermal Patch', 'description': 'Patients received rivastigmine 13.3 mg/24 h (15 cm\\^2).'}], 'classes': [{'title': 'Marked improvement', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Moderate improvement', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000'}]}]}, {'title': 'Minimal improvement', 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '26.2', 'groupId': 'OG000'}]}]}, {'title': 'Minimal worsening', 'categories': [{'measurements': [{'value': '31.5', 'groupId': 'OG000'}]}]}, {'title': 'Moderate worsening', 'categories': [{'measurements': [{'value': '21.5', 'groupId': 'OG000'}]}]}, {'title': 'Marked worsening', 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline of the core study to Week 24 of the extension study', 'description': "The ADCS-CGIC assesses the clinical meaningfulness of a treatment based on the clinician's rating of change. The rating is provided by a trained clinician or psychometrician blinded to the patient's treatment. The rater interviewed the patient and caregiver separately at Baseline using a worksheet that provided space for notes and comments. At baseline, raters had access to all of the patient's available records and evaluations. The rater used a similar worksheet at follow-up visits, and referred to the baseline worksheet prior to making a rating of change. The worksheets were divided into 3 domains: mental/cognitive state, behavior, and functioning. Change ratings were based on a 7-point scale: Marked (1), moderate (2), and minimal improvement (3), no change (4), and marked (5), moderate (6), and minimal worsening (7). The percentage of patients in each of the 7 categories is reported.", 'unitOfMeasure': 'Percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified full analysis set: All patients who received at least 1 application of study medication and had at least 1 efficacy assessment in the extension study. Only patients with available data were included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rivastigmine 13.3 mg/24 h Transdermal Patch', 'description': 'Patients received rivastigmine 13.3 mg/24 h (15 cm\\^2).'}, {'id': 'FG001', 'title': 'Rivastigmine 4.6 mg/24 h Transdermal Patch', 'description': 'Patients received rivastigmine 4.6 mg/24 h (5 cm\\^2).'}], 'periods': [{'title': 'Core Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '356'}, {'groupId': 'FG001', 'numSubjects': '360'}]}, {'type': 'Exposed to Study Medication', 'achievements': [{'groupId': 'FG000', 'numSubjects': '355'}, {'groupId': 'FG001', 'numSubjects': '359'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '229'}, {'groupId': 'FG001', 'numSubjects': '234'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '127'}, {'groupId': 'FG001', 'numSubjects': '126'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '51'}]}, {'type': 'Unsatisfactory Therapeutic Effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Patient Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Administrative Problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}, {'title': 'Extension Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '397 of the 463 patients who completed the core study entered the extension study.', 'groupId': 'FG000', 'numSubjects': '397'}, {'comment': 'No patients received this treatment in the extension study.', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Exposed to Study Medication', 'achievements': [{'groupId': 'FG000', 'numSubjects': '396'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '306'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Unsatisfactory Therapeutic Effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Study Drug No Longer Required', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Patient Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Administrative Problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'One patient in each treatment group in the core study and one patient in the treatment group in the extension study did not receive study medication; they were not included in the safety set.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '356', 'groupId': 'BG000'}, {'value': '360', 'groupId': 'BG001'}, {'value': '716', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Core Study: Rivastigmine 13.3 mg/24 h Transdermal Patch', 'description': 'Patients received rivastigmine 13.3 mg/24 h (15 cm\\^2).'}, {'id': 'BG001', 'title': 'Core Study: Rivastigmine 4.6 mg/24 h Transdermal Patch', 'description': 'Patients received rivastigmine 4.6 mg/24 h (5 cm\\^2).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '77.6', 'spread': '8.69', 'groupId': 'BG000'}, {'value': '76.5', 'spread': '9.35', 'groupId': 'BG001'}, {'value': '77.0', 'spread': '9.04', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '227', 'groupId': 'BG000'}, {'value': '234', 'groupId': 'BG001'}, {'value': '461', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '255', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 716}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-19', 'studyFirstSubmitDate': '2009-07-28', 'resultsFirstSubmitDate': '2013-01-08', 'studyFirstSubmitQcDate': '2009-07-28', 'lastUpdatePostDateStruct': {'date': '2013-08-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-01-08', 'studyFirstPostDateStruct': {'date': '2009-07-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Core Study: Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living-Severe Impairment Version (ADCS-ADL-SIV) Score at Week 24", 'timeFrame': 'Baseline of the core study to Week 24 of the core study', 'description': 'The ADCS-ADL-SIV is designed to assess the patient\'s performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, and making judgments and decisions. For each of the 19 questions in the ADCS-ADL-SIV, there was either a forced choice of best response or a "yes" or "no" question with additional sub-questions. Responses for each item were obtained from the caregiver through an interview. Higher numbered scores and answers of "yes" reflected a more self-sufficient individual. The total score was calculated as the sum of all items and sub-questions and ranged from 0 to 54. A higher total score represented a higher functioning patient. A positive change score indicates improvement.'}, {'measure': 'Core Study: Change From Baseline in the Severity Impairment Battery (SIB) Score at Week 24', 'timeFrame': 'Baseline of the core study to Week 24 of the core study', 'description': 'The SIB is a 40-item scale developed for the evaluation of the severity of cognitive dysfunction in more advanced Alzheimer Disease patients. The domains assessed included social interaction, memory, language, attention, orientation, praxis, visuo-spatial ability, construction, and orienting to name. The items of the SIB were developed as simple 1-step commands which are presented by a trained rater with gestural cues and repeated if necessary. The SIB was scored from 0 to 100, with higher scores reflecting higher levels of cognitive ability. A positive change score indicates improvement.'}], 'secondaryOutcomes': [{'measure': "Core Study: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Score at Week 24", 'timeFrame': 'Baseline of the core study to Week 24 of the core study', 'description': "The ADCS-CGIC assesses the clinical meaningfulness of a treatment based on the clinician's rating of change. The rating is provided by a trained clinician or psychometrician blinded to the patient's treatment. The rater interviewed the patient and caregiver separately at Baseline using a worksheet that provided space for notes and comments. At baseline, raters had access to all of the patient's available records and evaluations. The rater used a similar worksheet at follow-up visits, and referred to the baseline worksheet prior to making a rating of change. The worksheets were divided into 3 domains: mental/cognitive state, behavior, and functioning. Change ratings were based on a 7-point scale: Marked (1), moderate (2), and minimal improvement (3), no change (4), and marked (5), moderate (6), and minimal worsening (7). The percentage of patients in each of the 7 categories is reported."}, {'measure': 'Core Study: Change From Baseline in the Neuropsychiatric Inventory (NPI-12) Score at Week 24', 'timeFrame': 'Baseline of the core study to Week 24 of the core study', 'description': 'The NPI-12 assesses a wide range of behaviors encountered in patients with dementia to provide a means of distinguishing the frequency and severity of behavioral changes over time. Ten behavioral and 2 neurovegetative domains were evaluated in an interview with the caregiver given by a mental health professional. The scale included both frequency and severity ratings of each domain as well as a composite domain score (frequency x severity). The sum of the composite scores for the 12 domains yielded the NPI-12 total score. The NPI-12 was scored from 0 to 144, with lower scores reflecting improvement in psychiatric behavior. A negative change score indicates improvement.'}, {'measure': "Extension Study: Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living-Severe Impairment Version (ADCS-ADL-SIV) Score at Week 24", 'timeFrame': 'Baseline of the core study to Week 24 of the extension study', 'description': 'The ADCS-ADL-SIV is designed to assess the patient\'s performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, and making judgments and decisions. For each of the 19 questions in the ADCS-ADL-SIV, there was either a forced choice of best response or a "yes" or "no" question with additional sub-questions. Responses for each item were obtained from the caregiver through an interview. Higher numbered scores and answers of "yes" reflected a more self-sufficient individual. The total score was calculated as the sum of all items and sub-questions and ranged from 0 to 54. A higher total score represented a higher functioning patient. A positive change score indicates improvement.'}, {'measure': 'Extension Study: Change From Baseline in the Severity Impairment Battery (SIB) Score at Week 24', 'timeFrame': 'Baseline of the core study to Week 24 of the extension study', 'description': 'The SIB is a 40-item scale developed for the evaluation of the severity of cognitive dysfunction in more advanced Alzheimer Disease patients. The domains assessed included social interaction, memory, language, attention, orientation, praxis, visuo-spatial ability, construction, and orienting to name. The items of the SIB were developed as simple 1-step commands which are presented by a trained rater with gestural cues and repeated if necessary. The SIB was scored from 0 to 100, with higher scores reflecting higher levels of cognitive ability. A positive change score indicates improvement.'}, {'measure': "Extension Study: Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Score at Week 24", 'timeFrame': 'Baseline of the core study to Week 24 of the extension study', 'description': "The ADCS-CGIC assesses the clinical meaningfulness of a treatment based on the clinician's rating of change. The rating is provided by a trained clinician or psychometrician blinded to the patient's treatment. The rater interviewed the patient and caregiver separately at Baseline using a worksheet that provided space for notes and comments. At baseline, raters had access to all of the patient's available records and evaluations. The rater used a similar worksheet at follow-up visits, and referred to the baseline worksheet prior to making a rating of change. The worksheets were divided into 3 domains: mental/cognitive state, behavior, and functioning. Change ratings were based on a 7-point scale: Marked (1), moderate (2), and minimal improvement (3), no change (4), and marked (5), moderate (6), and minimal worsening (7). The percentage of patients in each of the 7 categories is reported."}]}, 'conditionsModule': {'keywords': ["Alzheimer's disease", 'dementia', "Alzheimer's type"], 'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '25523430', 'type': 'DERIVED', 'citation': "Grossberg GT, Farlow MR, Meng X, Velting DM. Evaluating high-dose rivastigmine patch in severe Alzheimer's disease: analyses with concomitant memantine usage as a factor. Curr Alzheimer Res. 2015;12(1):53-60. doi: 10.2174/1567205011666141218122835."}]}, 'descriptionModule': {'briefSummary': "The core study assessed the efficacy of a higher dose of rivastigmine 13.3 mg/24 h transdermally (15 cm\\^2 patch) compared to a lower dose of the rivastigmine 4.6 mg/24 h transdermally (5 cm\\^2 patch) in patients with Severe Dementia of the Alzheimer's Type in a 24-week study. The extension study obtained additional safety and efficacy data, as well as provided the higher dose rivastigmine patch to all patients who completed the core study for an additional 24 weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Core study\n\nInclusion Criteria:\n\n* Diagnosis of probable Alzheimer's disease (AD) according to National Institute of Neurological Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria.\n* A Mini-Mental State Examination (MMSE) score of ≥ 3 and ≤ 12.\n* Be able to complete at least 1 item on the Severe Impairment Battery (SIB).\n* Residing with someone in the community or in regular contact with the primary caregiver.\n* Be ambulatory or ambulatory with aid.\n\nExclusion Criteria:\n\n* An advanced, severe, progressive, or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient at special risk.\n* Patients currently residing in a nursing home.\n* Any current medical or neurological condition other than AD that could explain the patient's dementia.\n* A current diagnosis of probable or possible vascular dementia.\n* A current diagnosis of severe or unstable cardiovascular disease.\n* A current diagnosis of bradycardia (\\< 50 beats per minute \\[bpm\\]), sick-sinus syndrome, or conduction defects.\n* Clinically significant urinary obstruction.\n* History of malignancy of any organ system within the past 5 years unless patient is verified to be in stable condition with no active metastasis.\n* Current diagnosis of an active skin lesion/disorder that would prevent the patient from using a transdermal patch every day.\n* A known exaggerated pharmacological sensitivity or hypersensitivity to drugs similar to rivastigmine, or to other cholinergic compounds.\n* Taken any of the following substances (at the time of the Baseline Visit \\[Visit 2\\]).\n* Succinylcholine-type muscle relaxants during the previous 2 weeks.\n* Lithium during the previous 2 weeks.\n* An investigational drug during the previous 4 weeks.\n* A drug or treatment known to cause major organ system toxicity during the previous 4 weeks.\n* Rivastigmine (oral or transdermal patch), donepezil, galantamine, other cholinesterase inhibitors (eg, tacrine, physostigmine, or pyridostigmine), or other approved treatments for Alzheimer's disease during the previous 2 weeks, with exception of stable treatment with memantine for at least 3 months before study entry (Visit 1).\n* Centrally acting anticholinergic drugs including tricyclic and tetracyclic antidepressants during the previous 4 weeks.\n* Selegiline unless taken at a stable dose during the previous 4 weeks.\n* Peripheral anticholinergics not taken at a stable dose during the previous 4 weeks.\n\nExtension study\n\nInclusion Criteria:\n\n* Complete the double-blind phase (Week 24) of the core study.\n* Provide, if mentally competent, a separate written informed consent prior to participation in the extension study. In addition, the patient's caregiver, will provide written informed consent prior to the patient's participation in the open-label extension study. If the patient is not able to provide written informed consent, written informed consent must be obtained from the legally authorized representative on the patient's behalf.\n* Continue to reside with someone in the community or in regular contact with the primary caregiver; patients who reside in an assisted living facility are eligible to participate.\n* Continue to have a primary caregiver willing to accept responsibility for supervising treatment (eg, application and removal of the patch daily at approximately the same time of day), assessing the condition of the patient throughout the extension study.\n* Must be medically stable and tolerating the current dose of rivastigmine patch as determined by the investigator.\n\nExclusion Criteria:\n\nRefer to the core study protocol for full details of the exclusion criteria.\n\n* Patients who discontinued the core study due to any reason are excluded.\n* No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients.\n\nOther protocol-defined inclusion/exclusion criteria applied to the study."}, 'identificationModule': {'nctId': 'NCT00948766', 'acronym': 'ACTION', 'briefTitle': "Effects of Rivastigmine Patch on Activities of Daily Living and Cognition in Patients With Severe Dementia of the Alzheimer's Type (ACTION) (Study Protocol CENA713DUS44, NCT00948766) and a 24 Week Open-label Extension to Study CENA713DUS44", 'nctIdAliases': ['NCT01054755'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': "A 24 Week, Prospective, Randomized, Parallel-group, Double-blind, Multi-center Study (ENA713DUS44) Comparing the Effects of Rivastigmine Patch 15 cm^2 vs. Rivastigmine Patch 5 cm^2 on ACTivities of Daily Living and CognitION in Patients With Severe Dementia of the Alzheimer's Type (ACTION) and a 24-week Open-label Extension to Study ENA713DUS44", 'orgStudyIdInfo': {'id': 'CENA713DUS44'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rivastigmine 13.3 mg/24 h transdermal patch', 'description': 'In the core study, patients were titrated to the rivastigmine 13.3 mg/24 h dose in 2 steps. For Weeks 1-4, patients received rivastigmine 4.6 mg/24 h. For Weeks 5-8, patients received rivastigmine 9.5 mg/24 h and placebo. For Weeks 9-24, patients received rivastigmine 13.3 mg/24 h and placebo. In the extension study, all patients were switched to rivastigmine 9.5 mg/24 h for a 4-week titration period and were then titrated up to 13.3 mg/24 h for a further 20 weeks of treatment.', 'interventionNames': ['Drug: Rivastigmine 4.6 mg/24 h (5 cm^2)', 'Drug: Rivastigmine 9.5 mg/24 h (10 cm^2)', 'Drug: Rivastigmine 13.3 mg/24 h (15 cm^2)', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rivastigmine 4.6 mg/24 h transdermal patch', 'description': 'In the core study, patients received rivastigmine 4.6 mg/24 h daily. For Weeks 1-4, patients received rivastigmine 4.6 mg/24 h. For Weeks 5-24, patients received rivastigmine 4.6 mg/24 h and placebo. No patients received this treatment in the extension study.', 'interventionNames': ['Drug: Rivastigmine 4.6 mg/24 h (5 cm^2)', 'Drug: Placebo']}], 'interventions': [{'name': 'Rivastigmine 4.6 mg/24 h (5 cm^2)', 'type': 'DRUG', 'otherNames': ['ENA713D', 'Exelon', 'Exelon patch'], 'description': 'Rivastigmine was supplied in a 5 cm\\^2 patch which released 4.6 mg/24 h. Patches were changed daily.', 'armGroupLabels': ['Rivastigmine 13.3 mg/24 h transdermal patch', 'Rivastigmine 4.6 mg/24 h transdermal patch']}, {'name': 'Rivastigmine 9.5 mg/24 h (10 cm^2)', 'type': 'DRUG', 'otherNames': ['ENA713D', 'Exelon', 'Exelon path'], 'description': 'Rivastigmine was supplied in a 10 cm\\^2 patch which released 9.5 mg/24 h. Patches were changed daily.', 'armGroupLabels': ['Rivastigmine 13.3 mg/24 h transdermal patch']}, {'name': 'Rivastigmine 13.3 mg/24 h (15 cm^2)', 'type': 'DRUG', 'otherNames': ['ENA713D', 'Exelon', 'Exelon patch'], 'description': 'Rivastigmine was supplied in a 15 cm\\^2 patch which released 13.3 mg/24 h. Patches were changed daily.', 'armGroupLabels': ['Rivastigmine 13.3 mg/24 h transdermal patch']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo patches were identical in size and composition to the corresponding rivastigmine patches, except that they did not contain rivastigmine. Patches were changed daily.', 'armGroupLabels': ['Rivastigmine 13.3 mg/24 h transdermal patch', 'Rivastigmine 4.6 mg/24 h transdermal patch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85282', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Clinical Research Advantage Inc./Neurological. Physicians of Arizona, Inc', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '86741', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Northwest Neuro Specialist, PLLC', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72034', 'city': 'Conway', 'state': 'Arkansas', 'country': 'United States', 'facility': 'IHS Research Center Inc.', 'geoPoint': {'lat': 35.0887, 'lon': -92.4421}}, {'zip': '94705', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'East Bay Physicians Medical Group', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '92626', 'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'facility': 'ATP Clinical Research, Inc.', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'zip': '90502', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Neuro Pain Medical Center', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Margolin Brain Institute', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative Neuroscience Network Inc.', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '92064', 'city': 'Poway', 'state': 'California', 'country': 'United States', 'facility': 'PCND Neuroscience Research Institute Inc./The Center for Memory and Aging', 'geoPoint': {'lat': 32.96282, 'lon': -117.03586}}, {'zip': '92374', 'city': 'Redlands', 'state': 'California', 'country': 'United States', 'facility': 'Anderson Clinical Research', 'geoPoint': {'lat': 34.05557, 'lon': -117.18254}}, {'zip': '94109', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco Clinical Research Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '92701', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Neuropsychiatric Research Center of Orange County', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '91403', 'city': 'Sherman Oaks', 'state': 'California', 'country': 'United States', 'facility': 'California Neuroscience Research Medical Group, Inc.', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '92591', 'city': 'Temecula', 'state': 'California', 'country': 'United States', 'facility': 'Viking Clinical Research Center', 'geoPoint': {'lat': 33.49364, 'lon': -117.14836}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative Neuroscience Network, Inc', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80014', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Senior Care of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33431', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research Studies Dept. of Clinical Science and Medical Education', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33064', 'city': 'Deerfield Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Quantum Laboratories Memory Disorder Center', 'geoPoint': {'lat': 26.31841, 'lon': -80.09977}}, {'zip': '33445', 'city': 'Delray Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Brain Matters Research, Inc.', 'geoPoint': {'lat': 26.46146, 'lon': -80.07282}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Neurologic Consultants, PA', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32547', 'city': 'Fort Walton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'White-Wilson Medical Center', 'geoPoint': {'lat': 30.42059, 'lon': -86.61707}}, {'zip': '33009', 'city': 'Hallandale', 'state': 'Florida', 'country': 'United States', 'facility': 'MD Clinical', 'geoPoint': {'lat': 25.9812, 'lon': -80.14838}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Sunrise Clinical Research, Inc', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Compass Research, LLC', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32514', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'Integrity Research, LLC', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '33952', 'city': 'Port Charlotte', 'state': 'Florida', 'country': 'United States', 'facility': 'Neurostudies, Inc.', 'geoPoint': {'lat': 26.97617, 'lon': -82.09064}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Stedman Clinical Trials, LLC', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '34285', 'city': 'Venice', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Clinical Trials', 'geoPoint': {'lat': 27.09978, 'lon': -82.45426}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Premiere Research Institute', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '60007', 'city': 'Elk Grove Village', 'state': 'Illinois', 'country': 'United States', 'facility': 'Alexian Brothers Neuroscience Institute', 'geoPoint': {'lat': 42.00392, 'lon': -87.97035}}, {'zip': '46514', 'city': 'Elkhart', 'state': 'Indiana', 'country': 'United States', 'facility': 'Elkhart Clinic, LLC', 'geoPoint': {'lat': 41.68199, 'lon': -85.97667}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Medical Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '66214', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'MidAmerica Neuroscience Reseach Institute', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'zip': '66502', 'city': 'Manhattan', 'state': 'Kansas', 'country': 'United States', 'facility': 'Precise Clinical Research Solutions', 'geoPoint': {'lat': 39.18361, 'lon': -96.57167}}, {'zip': '71103', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'LSU Health Sciences Center/Department of Psychiatry Psychopharmacology Research Clinic', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '71104', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'J. Gary Booker, MD APMC', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '21208', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Pharmasite Research', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21601', 'city': 'Easton', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Samuel and Alexia Bratton Memory Clinic, William Hill Inc', 'geoPoint': {'lat': 38.77428, 'lon': -76.07633}}, {'zip': '01201', 'city': 'Pittsfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Neuroscience Research of the Berkshires', 'geoPoint': {'lat': 42.45008, 'lon': -73.24538}}, {'zip': '48035', 'city': 'Clinton Township', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Neurology Associates, P.C.', 'geoPoint': {'lat': 42.58698, 'lon': -82.91992}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University/Detroit Medical center', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '49442', 'city': 'Muskegon', 'state': 'Michigan', 'country': 'United States', 'facility': 'West Michigan Clinical Research', 'geoPoint': {'lat': 43.23418, 'lon': -86.24839}}, {'zip': '55114', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Orr & Associates Memory and Geriatric Behavioral Health Clinic', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '39401', 'city': 'Hattiesburg', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Neurological Research Clinic, Hattiesburg Clinic', 'geoPoint': {'lat': 31.32712, 'lon': -89.29034}}, {'zip': '39564', 'city': 'Ocean Springs', 'state': 'Mississippi', 'country': 'United States', 'facility': 'The Neuroscience Center', 'geoPoint': {'lat': 30.41131, 'lon': -88.82781}}, {'zip': '63104', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63117', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Sky, LLC.', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68510', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Premier Psychiatric Research Institute, LLC', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '68105', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '07724', 'city': 'Eatontown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memory Enhancement Center of America, Inc.', 'geoPoint': {'lat': 40.29622, 'lon': -74.05097}}, {'zip': '07856', 'city': 'Mount Arlington', 'state': 'New Jersey', 'country': 'United States', 'facility': 'NeuroCognitive Institute', 'geoPoint': {'lat': 40.92593, 'lon': -74.63488}}, {'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'UMDNJ-Robert Wood Johnson Medical Center', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '08759', 'city': 'Paterson', 'state': 'New Jersey', 'country': 'United States', 'facility': "Alzheimer's Research Corporation", 'geoPoint': {'lat': 40.91677, 'lon': -74.17181}}, {'zip': '08084', 'city': 'Stratford', 'state': 'New Jersey', 'country': 'United States', 'facility': 'UMDNJ-School of Osteopathic Medicine Center', 'geoPoint': {'lat': 39.82678, 'lon': -75.01545}}, {'zip': '08755', 'city': 'Toms River', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memory Enhancement Center of NJ', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}, {'zip': '12205', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Upstate Clinical Research, LLC', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '14226', 'city': 'Amherst', 'state': 'New York', 'country': 'United States', 'facility': 'Dent Neurological Institute', 'geoPoint': {'lat': 42.97839, 'lon': -78.79976}}, {'zip': '13088', 'city': 'Liverpool', 'state': 'New York', 'country': 'United States', 'facility': 'Neurological Care of Central NY', 'geoPoint': {'lat': 43.10646, 'lon': -76.2177}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Eastside Comprehensive medical Center, LLC', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10962', 'city': 'Orangeburg', 'state': 'New York', 'country': 'United States', 'facility': 'Nathan S. Kline Institute for Psychiatric Research', 'geoPoint': {'lat': 41.04649, 'lon': -73.94958}}, {'zip': '10305', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Behavioral Medical Research of Staten Island', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': '10312', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Richmond Behavioral Associates', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': '10605', 'city': 'White Plains', 'state': 'New York', 'country': 'United States', 'facility': 'The Burke Rehabilitation Hospital', 'geoPoint': {'lat': 41.03399, 'lon': -73.76291}}, {'zip': '28211', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': "Alzheimer's Memory Center", 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Clinical Trials of America, Inc.', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45459', 'city': 'Centerville', 'state': 'Ohio', 'country': 'United States', 'facility': 'Valley Medical Research', 'geoPoint': {'lat': 39.62839, 'lon': -84.15938}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Neurology, Inc.', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97225', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Cognitive Assessment Clinic', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '18104', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lehigh Center for Clinical Research', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '15017', 'city': 'Bridgeville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Paramount Clinical Research', 'geoPoint': {'lat': 40.35618, 'lon': -80.11006}}, {'zip': '19320', 'city': 'Coatesville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Department of Veterans Affairs Medical Center', 'geoPoint': {'lat': 39.98316, 'lon': -75.82384}}, {'zip': '15601', 'city': 'Greensburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Westmoreland Neurology associates, Inc.', 'geoPoint': {'lat': 40.30146, 'lon': -79.53893}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15243', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Protocol Management Specialists', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02914', 'city': 'East Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Mood & Memory Research Institute', 'geoPoint': {'lat': 41.81371, 'lon': -71.37005}}, {'zip': '37067', 'city': 'Franklin', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Psychiatric Consultants, PC', 'geoPoint': {'lat': 35.92506, 'lon': -86.86889}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Volunteer Research Group', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'zip': '77521', 'city': 'Baytown', 'state': 'Texas', 'country': 'United States', 'facility': 'Jacinto Medical Group, PA', 'geoPoint': {'lat': 29.7355, 'lon': -94.97743}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Future Search Trials', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Innovative Clinical Trials', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Radiant Research Inc.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '76309', 'city': 'Wichita Falls', 'state': 'Texas', 'country': 'United States', 'facility': 'Grayline Clinical Drug Trials', 'geoPoint': {'lat': 33.91371, 'lon': -98.49339}}, {'zip': '05201', 'city': 'Bennington', 'state': 'Vermont', 'country': 'United States', 'facility': 'The Memory Clinic', 'geoPoint': {'lat': 42.87813, 'lon': -73.19677}}, {'zip': '22205', 'city': 'Arlington', 'state': 'Virginia', 'country': 'United States', 'facility': 'TLC Neurology, P.L.L.C', 'geoPoint': {'lat': 38.88101, 'lon': -77.10428}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'UVA Neurology', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '23226', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Neurological Associates, Inc.', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '23230', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Alliance Research Group, LLC', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '23185', 'city': 'Williamsburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'The Center for Excellence in Aging and Geriatric Health', 'geoPoint': {'lat': 37.2707, 'lon': -76.70746}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Internal Medicine Northwest', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '53188', 'city': 'Waukesha', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Independent Psychiatric Consultants, SC', 'geoPoint': {'lat': 43.01168, 'lon': -88.23148}}, {'zip': '00959', 'city': 'Bayamón', 'country': 'Puerto Rico', 'facility': 'Metro Medical Center', 'geoPoint': {'lat': 18.39856, 'lon': -66.15572}}, {'zip': '00918', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'INSPIRA Clinical Research', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}