Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-12 @ 7:29 AM
Study NCT ID:
NCT00478205
Status:
COMPLETED
Last Update Posted:
2014-07-11
First Post:
2007-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of 23 mg Donepezil Sustained Release (SR) to 10 mg Donepezil Immediate Release (IR) in Patients With Moderate to Severe Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'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': 'D000077265', 'term': 'Donepezil'}], 'ancestors': [{'id': 'D007189', 'term': 'Indans'}, {'id': 'D007192', 'term': 'Indenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '888-422-4743', 'title': 'Eisai Inc.', 'organization': 'Eisai Call Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'All adverse events (AEs) were recorded from the time of informed consent until after the Final Visit or Early Termination.', 'description': 'Serious adverse events (SAEs) were monitored through the termination visit and through 30 days after study drug discontinuation, whichever was longer.', 'eventGroups': [{'id': 'EG000', 'title': 'Donepezil SR 23 mg', 'description': 'Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.', 'otherNumAtRisk': 963, 'otherNumAffected': 233, 'seriousNumAtRisk': 963, 'seriousNumAffected': 80}, {'id': 'EG001', 'title': 'Donepezil IR 10 mg', 'description': 'Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.', 'otherNumAtRisk': 471, 'otherNumAffected': 50, 'seriousNumAtRisk': 471, 'seriousNumAffected': 45}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 113}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Cardiovascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Diarrhoea haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Oesophageal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Drowning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Hypothermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Bile duct stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Cholangitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Burns first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Burns second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Neck injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Mobility decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Abdominal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Prostate cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Cerebellar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Grand mal convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Thalamic infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Unresponsive to stimuli', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Abnormal behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Behavioural and psychiatric symptoms of dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Delusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Paranoia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Poriomania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Breast mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Pneumomediastinum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 963, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 471, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 24 in SIB Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '909', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Donepezil SR 23 mg', 'description': 'Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.'}, {'id': 'OG001', 'title': 'Donepezil IR 10 mg', 'description': 'Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.66', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'The SIB is an assessment of cognitive dysfunction across nine domains such as memory, language, and orientation. The score ranges from 0 (worst) to 100 (best). This outcome was calculated using the LOCF (last observation carried forward) method.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population: All Randomized patients in Safety Population and Severe Impairment Battery (SIB) or Clinician Interview-Based Impression of Severity Plus Caregiver Input (CIBIS+) data available at Baseline and SIB or Clinician Interview-Based Impression of Change Plus caregiver Input (CIBIC+ ) data available post-Baseline; LOCF'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 24 in ADCS-ADL Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '909', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Donepezil SR 23 mg', 'description': 'Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.'}, {'id': 'OG001', 'title': 'Donepezil IR 10 mg', 'description': 'Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'spread': '6.83', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '6.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': "The ADCS-ADL (Alzhemier's Disease Cooperative Study-Activities of Daily Living) is a 19-item assessment scale used to measure a patient's basic functional abilities, such as walking, grooming, and bathing.Scores range from 0 to 54, with a higher score indicating greater functional ability.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population, LOCF'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 24 in MMSE Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '909', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Donepezil SR 23 mg', 'description': 'Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.'}, {'id': 'OG001', 'title': 'Donepezil IR 10 mg', 'description': 'Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '2.93', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '3.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'The MMSE (Mini-Mental State Examination) is a 30-item test that evaluates 5 domains of cognitive function (orientation to time and place, immediate and delayed recall, attention, calculation, and language). The scores range from 0 (most impaired) to 30 (no impaiment).', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population, LOCF'}, {'type': 'PRIMARY', 'title': 'Overall Change From Baseline in Modified CIBIC+ to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '909', 'groupId': 'OG000'}, {'value': '462', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Donepezil SR 23 mg', 'description': 'Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.'}, {'id': 'OG001', 'title': 'Donepezil IR 10 mg', 'description': 'Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.23', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '4.29', 'spread': '1.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'The CIBIC+ is a rating scale derived from an interview with the patient and caregiver with an independent rater designed to measure several domains of patient function, such as mental/cognitive state, behavior, and activities of daily living. The scores range from 1 (marked improvement) to 7 (marked worsening).', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population, LOCF'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Donepezil SR 23 mg', 'description': 'Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.'}, {'id': 'FG001', 'title': 'Donepezil IR 10 mg', 'description': 'Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '981'}, {'groupId': 'FG001', 'numSubjects': '486'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '685'}, {'groupId': 'FG001', 'numSubjects': '399'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '296'}, {'groupId': 'FG001', 'numSubjects': '87'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '182'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'Medication Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Request of Investigator or Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '963', 'groupId': 'BG000'}, {'value': '471', 'groupId': 'BG001'}, {'value': '1434', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Donepezil SR 23 mg', 'description': 'Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.'}, {'id': 'BG001', 'title': 'Donepezil IR 10 mg', 'description': 'Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.9', 'spread': '8.53', 'groupId': 'BG000'}, {'value': '73.8', 'spread': '8.56', 'groupId': 'BG001'}, {'value': '73.8', 'spread': '8.53', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Safety Population', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '607', 'spread': '63.0', 'groupId': 'BG000'}, {'value': '294', 'spread': '62.4', 'groupId': 'BG001'}, {'value': '901', 'spread': '62.8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '356', 'spread': '37.0', 'groupId': 'BG000'}, {'value': '177', 'spread': '37.6', 'groupId': 'BG001'}, {'value': '533', 'spread': '37.2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Safety Population: All patients randomized who took at least one dose of study medication and who had at least one postbaseline safety assessment.', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '708', 'groupId': 'BG000'}, {'value': '346', 'groupId': 'BG001'}, {'value': '1054', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}, {'title': 'Native American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Asian/Pacific', 'categories': [{'measurements': [{'value': '161', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '248', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Race (Safety Population)', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1467}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'dispFirstSubmitDate': '2010-02-17', 'lastUpdateSubmitDate': '2014-06-26', 'studyFirstSubmitDate': '2007-05-22', 'dispFirstSubmitQcDate': '2010-02-17', 'resultsFirstSubmitDate': '2012-11-12', 'studyFirstSubmitQcDate': '2007-05-23', 'dispFirstPostDateStruct': {'date': '2010-04-27', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-07-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-01-02', 'studyFirstPostDateStruct': {'date': '2007-05-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 24 in SIB Total Score', 'timeFrame': 'Baseline and Week 24', 'description': 'The SIB is an assessment of cognitive dysfunction across nine domains such as memory, language, and orientation. The score ranges from 0 (worst) to 100 (best). This outcome was calculated using the LOCF (last observation carried forward) method.'}, {'measure': 'Overall Change From Baseline in Modified CIBIC+ to Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'The CIBIC+ is a rating scale derived from an interview with the patient and caregiver with an independent rater designed to measure several domains of patient function, such as mental/cognitive state, behavior, and activities of daily living. The scores range from 1 (marked improvement) to 7 (marked worsening).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 24 in ADCS-ADL Total Score', 'timeFrame': 'Baseline and Week 24', 'description': "The ADCS-ADL (Alzhemier's Disease Cooperative Study-Activities of Daily Living) is a 19-item assessment scale used to measure a patient's basic functional abilities, such as walking, grooming, and bathing.Scores range from 0 to 54, with a higher score indicating greater functional ability."}, {'measure': 'Change From Baseline to Week 24 in MMSE Total Score', 'timeFrame': 'Baseline and Week 24', 'description': 'The MMSE (Mini-Mental State Examination) is a 30-item test that evaluates 5 domains of cognitive function (orientation to time and place, immediate and delayed recall, attention, calculation, and language). The scores range from 0 (most impaired) to 30 (no impaiment).'}]}, 'conditionsModule': {'keywords': ["Moderate to Severe Alzheimer's Disease"], 'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '24073978', 'type': 'DERIVED', 'citation': "Schmitt FA, Saxton J, Ferris SH, Mackell J, Sun Y. Evaluation of an 8-item Severe Impairment Battery (SIB-8) vs. the full SIB in moderate to severe Alzheimer's disease patients participating in a donepezil study. Int J Clin Pract. 2013 Oct;67(10):1050-6. doi: 10.1111/ijcp.12188."}, {'pmid': '22930699', 'type': 'DERIVED', 'citation': "Salloway S, Mintzer J, Cummings JL, Geldmacher D, Sun Y, Yardley J, Mackell J. Subgroup analysis of US and non-US patients in a global study of high-dose donepezil (23 mg) in moderate and severe Alzheimer's disease. Am J Alzheimers Dis Other Demen. 2012 Sep;27(6):421-32. doi: 10.1177/1533317512454708."}, {'pmid': '22572767', 'type': 'DERIVED', 'citation': "Doody RS, Geldmacher DS, Farlow MR, Sun Y, Moline M, Mackell J. Efficacy and safety of donepezil 23 mg versus donepezil 10 mg for moderate-to-severe Alzheimer's disease: a subgroup analysis in patients already taking or not taking concomitant memantine. Dement Geriatr Cogn Disord. 2012;33(2-3):164-73. doi: 10.1159/000338236. Epub 2012 May 10."}, {'pmid': '21689411', 'type': 'DERIVED', 'citation': "Ferris SH, Schmitt FA, Saxton J, Richardson S, Mackell J, Sun Y, Xu Y. Analyzing the impact of 23 mg/day donepezil on language dysfunction in moderate to severe Alzheimer's disease. Alzheimers Res Ther. 2011 Jun 20;3(3):22. doi: 10.1186/alzrt84."}, {'pmid': '21612646', 'type': 'DERIVED', 'citation': "Farlow M, Veloso F, Moline M, Yardley J, Brand-Schieber E, Bibbiani F, Zou H, Hsu T, Satlin A. Safety and tolerability of donepezil 23 mg in moderate to severe Alzheimer's disease. BMC Neurol. 2011 May 25;11:57. doi: 10.1186/1471-2377-11-57."}, {'pmid': '20678673', 'type': 'DERIVED', 'citation': "Farlow MR, Salloway S, Tariot PN, Yardley J, Moline ML, Wang Q, Brand-Schieber E, Zou H, Hsu T, Satlin A. Effectiveness and tolerability of high-dose (23 mg/d) versus standard-dose (10 mg/d) donepezil in moderate to severe Alzheimer's disease: A 24-week, randomized, double-blind study. Clin Ther. 2010 Jul;32(7):1234-51. doi: 10.1016/j.clinthera.2010.06.019."}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to compare 23 mg donepezil sustained release (SR) to the currently marketed formulation of 10 mg donepezil immediate release (IR) in patients with moderate to severe Alzheimer's disease.", 'detailedDescription': "This study consists of a double-blind, double-dummy, parallel-group comparison of 23 mg donepezil SR with the currently marketed donepezil formulation (10 mg donepezil IR) in patients with moderate to severe Alzheimer's disease. Patients must have been taking 10 mg IR (or a bioequivalent generic) for at least 3 months prior to Screening. The study will consist of 24 weeks of daily administration of study medication, with clinic visits at Screening, Baseline, 3 weeks (safety only), 6 weeks, 12 weeks, 18 weeks and 24 weeks or early termination. Patients will receive either 10 mg donepezil IR in combination with the placebo corresponding to 23 mg donepezil SR, or 23 mg donepezil SR in combination with the placebo corresponding to 10 mg donepezil IR.\n\nA total of approximately 1600 patients will be enrolled to obtain complete data from approximately 1200 completed patients (Revised per Amendment 02). During the Baseline visit, patients will be randomized in a 2:1 ratio (23 mg donepezil SR to 10 mg donepezil IR). The study will be performed at approximately 200 global sites (Asia, Oceania, Europe, India, Israel, North America, South Africa, and South America) (Revised per Amendments 01 and 02). An Independent Data Monitoring Committee (IDMC) will be established to review safety aspects of the study and to evaluate the results of a planned interim analysis.\n\nPatients who complete the study may be eligible to undergo evaluation for enrollment into the open-label extension study, E2020-G000-328."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria for Patients:\n\n1. Written informed consent.\n2. Patient Age range: Adult patients, 45 to 90 years of age, inclusive.\n3. The caregiver must separately meet the specified inclusion/exclusion criteria for caregivers.\n4. Women must be of non-child-bearing potential (\\>1 year post-menopausal or surgically sterile).\n5. There must be diagnostic evidence of probable Alzheimer's disease (AD).\n6. The patient must have been receiving Aricept at a dose of dose of 10 mg IR (or 10 mg dose of generic donepezil bioequivalent to Aricept), for at least 3 months prior to the Screening visit.\n7. A cranial image is required, with no evidence of focal brain disease that would account for dementia.\n8. The patient must meet certain psychometric test criteria related to the degree of impairment of cognitive functioning.\n9. Health: physically healthy and ambulatory or ambulatory-aided (i.e., walker or cane); corrected vision and hearing sufficient for compliance with testing procedures, and able to read prior to disease onset.\n10. Clinical laboratory values must be within normal limits or, if abnormal, must be judged not clinically significant by the investigator.\n11. Specified doses of selective serotonin reuptake inhibitors (SSRIs) are allowed in the study if dosage is within approved dose range and stable for 3 months prior to Screening.\n12. Other medical conditions, such as hypertension and cardiac disease must be well-controlled and the patient maintained on stable doses of medications for 3 months.\n13. Patients with diabetes mellitus or risk factors for diabetes mellitus may be enrolled in the study provided that the patient's disease is stable and that there have been no recent hospitalizations for diabetes complications.\n14. Patients whose serum B12 levels at Screening are below the normal range may nonetheless be admitted to the study if they subsequently show normal levels prior to Baseline.\n15. Patients with hypothyroidism who are on a stable dose of medication for at least 12 weeks prior to Screening, have normal TSH and free T4 at Screening, and are considered euthyroid will be eligible.\n16. Concomitant Medications: Under specified circumstances, the following medications may be allowed: chronic daily benzodiazepine use, bronchodilator medications for treatment of chronic obstructive pulmonary disease (COPD), and memantine. Certain other additional prescription treatments for AD, such as other cholinesterase inhibitors, must have been discontinued for at least 3 months prior to screening.\n17. The patient must have a relative/caregiver who supervises the regular taking of the drug at the correct dose and is alert for possible side effects, unless the patient's legal guardian takes on this task.\n\nInclusion Criteria for Caregivers:\n\nThe designated caregiver must be sufficiently familiar with the patient (as determined by the investigator) to provide accurate data. The caregiver must have regular contact with the patient (i.e., an average of 10 or more hours per week), must be able to observe for possible adverse events, and must be able to accompany the patient to all visits.\n\nExclusion Criteria for Patients:\n\n1. Patients are excluded if they are taking (a) no medication for Alzheimer's disease, (b) Aricept or bioequivalent generic donepezil at doses other than 10 mg daily, or 10 mg for less than 3 months before Screening; (c) other medications for Alzheimer's disease, except that memantine, Vitamin E, fish oil, and/or gingko biloba are allowed if doses have been stable for at least 3 months prior to the Screening visit. Patients undergoing any alternative medical techniques, such as acupuncture or acupressure, specifically for the treatment of AD are not eligible\n2. No caregiver available to meet the inclusion criteria for caregivers.\n3. Patients who have no measurable blood levels of donepezil in blood samples collected at Screening.\n4. Patients with neurological disorders that affect cognition or the ability to assess cognition but are distinguishable from Alzheimer's disease. These include, but are not limited to, Parkinson's disease, multi-infarct dementia, and dementia due to cerebrovascular disease.\n5. Patients with psychiatric disorders affecting the ability to assess cognition such as schizophrenia, bipolar or unipolar depression. Patients with clinically significant sleep disorders will also be excluded unless these are controlled by treatment and clinically stable for \\> 3 months prior to screening.\n6. Patients with dementia complicated by other organic disease or Alzheimer's disease with delirium.\n7. Patients with drug or alcohol abuse or dependence within the past 5 years according to DSM IV criteria.\n8. Patients with any conditions affecting absorption, distribution, or metabolism of the study medication (e.g., inflammatory bowel disease, gastric or duodenal ulcers, hepatic disease, or severe lactose intolerance).\n9. Patients with evidence of clinically significant, active gastrointestinal, renal, hepatic, respiratory, endocrine, or cardiovascular system disease (including history of life-threatening arrhythmias).\n10. Patients with a history of cancer (does not include basal or squamous cell carcinoma of the skin) treated within 5 years prior to study entry, or current evidence of malignant neoplasm, recurrent, metastatic disease. Males with localized prostate cancer requiring no treatment would not be excluded.\n11. Known plan for elective surgery during the treatment period that would require general anesthesia and administration of neuromuscular blocking agents.\n12. Donation of blood or blood products during 30 days prior to Screening or plans to donate blood while participating in the study or within 30 days after completion of the study.\n13. Patients who are unwilling or unable to fulfill the requirements of the study.\n14. Known hypersensitivity to acetylcholinesterase inhibitors or memantine.\n15. Use of any prohibited prior or concomitant medications) Any condition that would make the patient, in the opinion of the investigator, unsuitable for the study.\n16. Involvement in any other investigational drug clinical trial during the preceding 3 months, or likely involvement in any other such trial during the course of this study.\n17. Patients taking concomitant antidepressant medication known to have significant anticholinergic effects, such as tricyclic antidepressants prescribed at doses recommended for the treatment of major depression.\n18. Patients who cannot swallow or who have difficult swallowing whole tablets.\n19. Patients with fecal and/or urinary incontinence who are unable to cooperate with routine specimen collection.\n\nExclusion Criteria for Caregivers:\n\n1. Caregivers who are unwilling or unable to give informed consent or otherwise to fulfill the requirements of the study.\n2. Caregivers who do not meet certain psychometric test criteria.\n3. Any condition that would make the caregiver, in the opinion of the Investigator, unsuitable for the study."}, 'identificationModule': {'nctId': 'NCT00478205', 'briefTitle': "Comparison of 23 mg Donepezil Sustained Release (SR) to 10 mg Donepezil Immediate Release (IR) in Patients With Moderate to Severe Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': "Double-Blind, Parallel-Group Comparison of 23 mg Donepezil Sustained Release (SR) to 10 mg Donepezil Immediate Release (IR) in Patients With Moderate to Severe Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'E2020-G000-326'}, 'secondaryIdInfos': [{'id': '2006-004888-54', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Aricept (donepezil SR 23 mg)']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: Aricept (donepezil IR 10 mg)']}], 'interventions': [{'name': 'Aricept (donepezil SR 23 mg)', 'type': 'DRUG', 'otherNames': ['Donepezil hydrochloride'], 'description': 'Patients will receive study medication orally, once daily, for 24 weeks according to a double-dummy design:\n\n23 mg donepezil SR concurrently with placebo identical in appearance to the 10 mg donepezil IR formulation.', 'armGroupLabels': ['1']}, {'name': 'Aricept (donepezil IR 10 mg)', 'type': 'DRUG', 'otherNames': ['Donepezil hydrochloride'], 'description': 'Patients will receive study medication orally, once daily, for 24 weeks according to a double-dummy design:\n\n10 mg donepezil IR concurrently with placebo identical in appearance to the 23 mg donepezil SR formulation.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28601', 'city': 'Hickory', 'state': 'North Carolina', 'country': 'United States', 'facility': 'MedTrials, Inc.', 'geoPoint': {'lat': 35.73319, 'lon': -81.3412}}], 'overallOfficials': [{'name': 'Jane Yardley, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eisai Limted'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eisai Limited', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}