Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT00490568
Status:
TERMINATED
Last Update Posted:
2017-11-13
First Post:
2007-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open-Label Extension Study Of Rosiglitazone XR As Adjunctive Therapy In Subjects With Mild-to-Moderate Alzheimers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Japan', 'Malaysia', 'Singapore', 'Switzerland']}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 76 Weeks', 'description': 'All subject (Full population) was used for analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'RSG XR', 'description': "Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer's disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR.", 'otherNumAtRisk': 1461, 'deathsNumAtRisk': 1461, 'otherNumAffected': 130, 'seriousNumAtRisk': 1461, 'deathsNumAffected': 20, 'seriousNumAffected': 126}], 'otherEvents': [{'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 130}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Drug toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pacemaker complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Soft tissue injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Subdural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Traumatic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': "Dementia Alzheimer's type", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nerve root compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Optic neuritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thalamic infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinus arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Brain cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lung neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': "Paget's disease of the breast", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Refractory anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Behavioural and psychiatric symptoms of dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Panic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lumbar hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Foot deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Osteoporotic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Synovial disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Post thrombotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood sodium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nephrotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Uterine prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1461, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Any Adverse Events (AEs) and Severity of AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1461', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG XR', 'description': "Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer's disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR.."}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '724', 'groupId': 'OG000'}]}]}, {'title': 'Mild AE', 'categories': [{'measurements': [{'value': '345', 'groupId': 'OG000'}]}]}, {'title': 'Moderate AE', 'categories': [{'measurements': [{'value': '289', 'groupId': 'OG000'}]}]}, {'title': 'Severe AE', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 76 Weeks', 'description': "An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The severity of the AE'S was categorized as mild, moderate and severe. Number of participants reporting AEs during the on treatment phase of the study.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects (Full population), comprised of all participants who took at least one dose of open-label study medication.'}, {'type': 'SECONDARY', 'title': 'Number Participants With Serious Adverse Events (SAEs) and Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1461', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG XR', 'description': "Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer's disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR."}], 'classes': [{'title': 'Any SAE', 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 76 Weeks', 'description': 'A SAE is defined as any untoward medical occurrence that, at any dose results in death, is a life-threatening condition, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or a congenital anomaly or birth defect. Number of participants with SAEs and deaths were reported for treatment duration of the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject (Full population)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Event of Oedema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1461', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG XR', 'description': "Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer's disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR."}], 'classes': [{'title': 'Oedema peripheral', 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}]}]}, {'title': 'Face oedema', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Pitting oedema', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Oedema', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Pulmonary oedema', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Eyelid oedema', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 76 Weeks', 'description': "Oedema was considered as adverse event of special interest (AESI). The process for AESI selection was based on RSG's pharmacologic class and relevant AEs potentially associated with RSG. The number of participants and their percentage for the adverse event of the various types of oedema were reported.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject (Full population)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vital Sign Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1461', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG XR', 'description': "Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer's disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR.."}], 'classes': [{'title': 'SBP at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '14.10', 'groupId': 'OG000'}]}]}, {'title': 'SBP at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1274', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '14.73', 'groupId': 'OG000'}]}]}, {'title': 'SBP at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '14.73', 'groupId': 'OG000'}]}]}, {'title': 'SBP at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1061', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.7', 'spread': '15.02', 'groupId': 'OG000'}]}]}, {'title': 'SBP at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '892', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '15.51', 'groupId': 'OG000'}]}]}, {'title': 'SBP at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '666', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '15.14', 'groupId': 'OG000'}]}]}, {'title': 'SBP at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '16.18', 'groupId': 'OG000'}]}]}, {'title': 'SBP at Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '13.78', 'groupId': 'OG000'}]}]}, {'title': 'SBP at Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1280', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '15.60', 'groupId': 'OG000'}]}]}, {'title': 'DBP at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1395', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '9.41', 'groupId': 'OG000'}]}]}, {'title': 'DBP at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1274', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '9.53', 'groupId': 'OG000'}]}]}, {'title': 'DBP at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '9.74', 'groupId': 'OG000'}]}]}, {'title': 'DBP at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1061', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '9.62', 'groupId': 'OG000'}]}]}, {'title': 'DBP at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '892', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '9.48', 'groupId': 'OG000'}]}]}, {'title': 'DBP at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '666', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '9.85', 'groupId': 'OG000'}]}]}, {'title': 'DBP at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.6', 'spread': '9.94', 'groupId': 'OG000'}]}]}, {'title': 'DBP at Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.3', 'spread': '6.72', 'groupId': 'OG000'}]}]}, {'title': 'DBP at Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1280', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '10.23', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 70 Weeks (including follow up)', 'description': 'Vital signs SBP and DBP were measured at each visit. All measurements were made on the participant non-dominant arm supported at heart level, using the same cuff size and same equipment. Blood pressure was measured once, after the participant sat quietly for at least 5 minutes. DBP was measured at the disappearance of Korotkoff sounds (Phase V). If the participant was a smoker or used tobacco products, a period of 30 minutes without tobacco was allowed before taking these measurements. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the blood pressure value recorded at specified visit minus the Baseline value.', 'unitOfMeasure': 'millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject (Full population). Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vital Sign Heart Rate (HR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1461', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG XR', 'description': "Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer's disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR."}], 'classes': [{'title': 'HR at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1391', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '8.95', 'groupId': 'OG000'}]}]}, {'title': 'HR at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1271', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '9.60', 'groupId': 'OG000'}]}]}, {'title': 'HR at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '9.77', 'groupId': 'OG000'}]}]}, {'title': 'HR at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1061', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '9.66', 'groupId': 'OG000'}]}]}, {'title': 'HR at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '888', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '9.99', 'groupId': 'OG000'}]}]}, {'title': 'HR at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '665', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '9.86', 'groupId': 'OG000'}]}]}, {'title': 'HR at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '8.54', 'groupId': 'OG000'}]}]}, {'title': 'HR at Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '8.02', 'groupId': 'OG000'}]}]}, {'title': 'HR at Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1276', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '10.03', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 70 Weeks (including follow up)', 'description': 'Vital sign HR was measured at each visit. HR was measured once, after the participant sat quietly for at least 5 minutes. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the HR at specified visit minus the Baseline value.', 'unitOfMeasure': 'beats per minute (bpm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject (Full population). Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vital Sign Body Weight (BW)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1461', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG XR', 'description': "Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer's disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR."}], 'classes': [{'title': 'BW at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1391', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.04', 'groupId': 'OG000'}]}]}, {'title': 'BW at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1263', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '2.45', 'groupId': 'OG000'}]}]}, {'title': 'BW at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '2.43', 'groupId': 'OG000'}]}]}, {'title': 'BW at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1057', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '3.53', 'groupId': 'OG000'}]}]}, {'title': 'BW at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '889', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '2.95', 'groupId': 'OG000'}]}]}, {'title': 'BW at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '666', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '4.08', 'groupId': 'OG000'}]}]}, {'title': 'BW at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '3.82', 'groupId': 'OG000'}]}]}, {'title': 'BW at Week 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '2.52', 'groupId': 'OG000'}]}]}, {'title': 'BW at Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1268', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '3.15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 70 Weeks (including follow up)', 'description': 'BW was measured at all visits, without shoes and wearing light clothing. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the body weight at specified visit minus the Baseline value.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject (Full population). Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Non-fasting Measures of Lipid Metabolism Namely Total Cholesterol (TC), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1461', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG XR', 'description': "Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer's disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR."}], 'classes': [{'title': 'TC at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1313', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.076', 'spread': '0.6828', 'groupId': 'OG000'}]}]}, {'title': 'TC at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1038', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.201', 'spread': '0.8666', 'groupId': 'OG000'}]}]}, {'title': 'TC at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '639', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.246', 'spread': '0.9649', 'groupId': 'OG000'}]}]}, {'title': 'TC at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.174', 'spread': '1.1437', 'groupId': 'OG000'}]}]}, {'title': 'TC at Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.715', 'spread': '0.3041', 'groupId': 'OG000'}]}]}, {'title': 'TC at follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '888', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.093', 'spread': '0.9377', 'groupId': 'OG000'}]}]}, {'title': 'HDL at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1313', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.007', 'spread': '0.2008', 'groupId': 'OG000'}]}]}, {'title': 'HDL at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1036', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.014', 'spread': '0.2427', 'groupId': 'OG000'}]}]}, {'title': 'HDL at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '639', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.026', 'spread': '0.2487', 'groupId': 'OG000'}]}]}, {'title': 'HDL at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.035', 'spread': '0.2512', 'groupId': 'OG000'}]}]}, {'title': 'HDL at Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.050', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated as a single participant was analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'HDL at follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '887', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.058', 'spread': '0.2605', 'groupId': 'OG000'}]}]}, {'title': 'LDL at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1263', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.062', 'spread': '0.6207', 'groupId': 'OG000'}]}]}, {'title': 'LDL at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1008', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.210', 'spread': '0.7782', 'groupId': 'OG000'}]}]}, {'title': 'LDL at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '623', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.281', 'spread': '0.8863', 'groupId': 'OG000'}]}]}, {'title': 'LDL at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.228', 'spread': '1.0563', 'groupId': 'OG000'}]}]}, {'title': 'LDL at Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.200', 'spread': 'NA', 'comment': 'Standard deviation could not be calculated as a single participant was analyzed.', 'groupId': 'OG000'}]}]}, {'title': 'LDL at follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '853', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.148', 'spread': '0.8336', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1313', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.004', 'spread': '0.7845', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1038', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.025', 'spread': '0.8053', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides at Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '639', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.062', 'spread': '0.8053', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.092', 'spread': '0.8521', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides at Week 76', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.150', 'spread': '0.9758', 'groupId': 'OG000'}]}]}, {'title': 'Triglycerides at follow up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '888', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.035', 'spread': '0.8295', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 82 Weeks (including follow up)', 'description': 'The clinical chemistry data included non-fasting measures of lipid metabolism (TC,HDL,LDL,triglycerides). Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the lipids (TC,HDL,LDL,triglycerides) value recorded at specified visit minus the Baseline value.', 'unitOfMeasure': 'millimole per litre (mmol/l)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject (Full population). Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With SBP and DBP Values of Potential Clinical Concern (PCC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1461', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG XR', 'description': "Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer's disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR."}], 'classes': [{'title': 'ATOT,SBP(RR)>140 or <90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1409', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '520', 'groupId': 'OG000'}]}]}, {'title': 'ATOT,SBP(IFB)>=40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1409', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'ATOT,SBP(DFB)>=30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1409', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '179', 'groupId': 'OG000'}]}]}, {'title': 'Follow up,SBP(RR)>140 or <90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1280', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '240', 'groupId': 'OG000'}]}]}, {'title': 'Follow up,SBP(IFB)>=40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1280', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Follow up,SBP(DFB)>=30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1280', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}]}]}, {'title': 'ATOT,DBP(RR)>90 or<50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1409', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}]}]}, {'title': 'ATOT,DBP(IFB)>=30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1409', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'ATOT,DBP(DFB)>= 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1409', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '211', 'groupId': 'OG000'}]}]}, {'title': 'Follow up,DBP(RR)>90 or<50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1280', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'Follow up,DBP(IFB)>=30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1280', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, DBP(DFB)>= 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1280', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 70 Weeks (including follow up)', 'description': 'The frequency of participant vital sign sitting blood pressure was obtained to check if the values lie outside of a pre-determined reference range (RR) for SBP 90-140 mmHg, DBP 50-90 mmHg or have a change from Baseline of PCC for SBP increase from Baseline (IFB) \\>=40, decrease from Baseline (DFB) \\>= 30 for and for DBP (IFB) \\>= 30 ,DFB \\>= 20. The number of participants with values of PCC at any time on treatment (ATOT) and follow up were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject (Full population). Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With HR Values of PCC ATOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1461', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG XR', 'description': "Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer's disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR."}], 'classes': [{'title': 'ATOT,HR (RR)>100 or <50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1409', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}]}]}, {'title': 'ATOT,HR (IFB)>=30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1409', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'ATOT,HR (DFB)>=30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1409', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Follow up,HR (RR)>100 or <50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1276', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Follow up,HR (IFB)>=30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1276', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Follow up,HR (DFB)>=30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1276', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 70 Weeks (including follow up)', 'description': 'HR was measured once, after the participant sat quietly for at least 5 minutes. The frequency of participant vital sign heart rate was obtained to check if the values lie outside of a pre-determined reference range (RR) 50-100 bpm or have a change from Baseline of PCC IFB \\>=30 and DFB \\>=30. The number of participants with values of PCC including follow up were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject (Full population). Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With BW Values of PCC ATOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1461', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG XR', 'description': "Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer's disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR."}], 'classes': [{'title': 'ATOT, BW(IFB)>=7 percent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1408', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '188', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, BW(DFB)>= 7 percent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1408', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, BW(IFB)>=7 percent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1270', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, BW(DFB)>= 7 percent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1270', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 70 Weeks (including follow up)', 'description': 'The frequency of participant vital sign weight was obtained to check if the values have CFB of PCC IFB \\>=7 percent. With the exception of Week 4, when participants were first titrated to the 8mg RSG XR dose, at every time point in the study where weight was measured the percentage of participants experienced an increase in BW of PCC was approximately 2 times greater than the percentage of participants experiencing an decrease in BW of PCC DFB \\>=7 percent. The number of participants with values of PCC including follow up were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject (Full population). Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hematology Parameters of PCC ATOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1461', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG XR', 'description': "Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer's disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR."}], 'classes': [{'title': 'ATOT, Eosinophils (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1384', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, Haematocrit (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1385', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, Haematocrit (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '910', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, Haemoglobin (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1385', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, Haemoglobin (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1385', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, Hemoglobin (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '910', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, Hemoglobin (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '910', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, Lymphocytes (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1384', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, Lymphocytes (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1384', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, Lymphocytes (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '909', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, Lymphocytes (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '909', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, MCH (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1211', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, MCH (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '785', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, MCV (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1385', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, monocytes (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1384', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, monocytes (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1384', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, monocytes (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '909', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, platelet count (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1381', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, platelet count (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1381', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, RDW (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1385', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '158', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, RDW (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '910', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, RBC (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1385', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, RBC (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '910', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, SN (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1384', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, SN (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1384', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, SN (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '909', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, SN (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '909', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, TN (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1384', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, TN (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1384', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, TN (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '909', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, TN (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '909', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, WBC (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1384', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, WBC (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1384', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, WBC (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '909', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, WBC (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '909', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 82 (including follow up)', 'description': 'The hematology data included eosinophils, haematocrit, haemoglobin, lymphocytes, mean corpuscular haemoglobin (MCH), mean corpuscular volume (MCV), monocytes, platelet count, red cell distribution width (RDW), red blood cell (RBC) count, segmented neutrophils (SN), total neutrophils (TN), white blood cell (WBC) count. The number of participants with values of PCC (defined as high and low) ATOT were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject (Full population). Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Chemistry Parameters (Including Lipids) of PCC ATOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1461', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG XR', 'description': "Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer's disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR."}], 'classes': [{'title': 'Follow up, ALT (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '908', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, Albumin (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '909', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, Aldolase (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '464', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, Aldolase (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '464', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, Aldolase (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, Aldolase (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, AST (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1385', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, AST (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '908', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, BUN/creatinine ratio (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1385', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, BUN/creatinine ratio (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '908', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, CO2 content (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1384', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, CO2 content (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '908', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, chloride (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1385', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, cholesterol (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1383', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '175', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, cholesterol (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '907', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, CK (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1385', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, CK (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '908', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, Creatinine (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1385', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, creatinine (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '908', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, DB (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1385', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, GGT (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1385', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, GGT (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '908', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, Glucose (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1385', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, Glucose (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1385', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, glucose (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '908', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, glucose (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '908', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, HbA1c (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '742', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, HDL (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1383', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, HDL (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '906', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, LDL (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1368', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '469', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, LDL (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '888', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '211', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, LD (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1384', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, LD (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '909', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, Magnesium (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1385', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, Magnesium (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '909', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, Potassium (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1384', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, Potassium (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1384', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, Potassium (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '909', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, Potassium (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '909', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, Sodium (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1385', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, Sodium (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1385', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, Sodium (low)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '909', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, TB (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1386', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, TB (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '908', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, Triglycerides (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1383', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, Troponin I (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '426', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, Troponin I (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'ATOT, Urea (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1385', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000'}]}]}, {'title': 'Follow up, Urea (high)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '909', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 82 (including follow up)', 'description': 'The clinical chemistry data included alanine amino transferase (ALT), albumin, aldolase, asparatate amino transferase (AST), BUN/creatinine ratio, carbon dioxide(CO2) content, chloride, cholesterol, creatinine kinase (CK), creatinine, direct bilirubin (DB), gamma glutamyl transferase (GGT), glucose, glycosylated Hemoglobin (HbA1C), HDL, LDL, lactate dehydrogenase (LD), magnesium, potassium, sodium, total bilirubin (TB), triglycerides, troponin I, urea. The number of participants with values of PCC (defined as high and low) ATOT were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population (Full population). Only those participants available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Total Score as a Function of Apolipoprotein E (APOE) ε4 Status.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '1461', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG XR', 'description': "Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer's disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR."}], 'classes': [{'title': 'Week 24 (Full population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '973', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '5.51', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (Full population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '6.82', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (APOE4 negatives)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '404', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '5.28', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (APOE4 negatives)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '6.44', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (APOE4 positives)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '569', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '5.66', 'groupId': 'OG000'}]}]}, {'title': 'Week 52(APOE4 positives)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.4', 'spread': '7.11', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (APOE4 E4 homozygotes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '5.77', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (APOE4 E4 homozygotes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '7.49', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (APOE4 E4 heterozygotes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '443', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '5.63', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (APOE4 E4 heterozygotes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.4', 'spread': '7.02', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Week 24, 52', 'description': 'The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. Scores ranged from 0 to 70 with higher scores indicating greater dysfunction. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.', 'unitOfMeasure': 'Scores on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject (Full population). Only those participants available at the specified time points were analyzed. The analysis was done on the full population and was repeated for APOE subgroups (negative, positive, homozygotes, heterozygotes).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score as a Function of APOE ε4 Status.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1461', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG XR', 'description': "Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer's disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR."}], 'classes': [{'title': 'Week 24 (Full population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '988', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.84', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (Full population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '313', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '2.26', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (APOE4 negatives)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '409', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.76', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (APOE4 negatives)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '2.19', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (APOE4 positives)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '579', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.89', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (APOE4 positives)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '2.30', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (APOE4 E4 homozygotes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.90', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (APOE4 E4 homozygotes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '2.32', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (APOE4 E4 heterozygotes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '452', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.89', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (APOE4 E4 heterozygotes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '2.30', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Week 24, 52', 'description': "The CDR-SB is a validated clinical assessment of global function in par. with Alzheimer's disease (AD). Impairment was scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or box scores, were added together to give the CDR-Sum of Boxes which ranged from 0 to 18 (severe impairment). Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.", 'unitOfMeasure': 'Scores on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population. Only those participants available at the specified time points were analyzed. The analysis was done on the full population and was repeated for APOE subgroups (negatives, positives, homozygotes, heterozygotes).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mini Mental State Examination (MMSE) Total Score as a Function of APOE ε4 Status.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1461', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG XR', 'description': "Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer's disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR."}], 'classes': [{'title': 'Week 24 (Full population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '833', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '2.84', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (Full population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '3.39', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (APOE4 negatives)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '2.74', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (APOE4 negatives)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '3.56', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (APOE4 positives)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '2.87', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (APOE4 positives)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '3.17', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (APOE4 E4 homozygotes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '3.07', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (APOE4 E4 homozygotes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '3.16', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (APOE4 E4 heterozygotes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '2.82', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (APOE4 E4 heterozygotes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '3.18', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Week 24, 52', 'description': 'The MMSE consisted of 11 tests of orientation, memory (recent and immediate), concentration, language and praxis. Scores ranged from 0 to 30, with lower scores indicating greater cognitive impairment. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.', 'unitOfMeasure': 'Scores on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject (Full population). Only those participants available at the specified time points were analyzed. The analysis was done on the full population and was repeated for APOE subgroups (negatives, positives, homozygotes, heterozygotes).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score as a Function of APOE ε4 Status.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1461', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG XR', 'description': "Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer's disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR."}], 'classes': [{'title': 'Week 24 (Full population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '837', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.6', 'spread': '12.36', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (Full population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.8', 'spread': '15.07', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (APOE4 negatives)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.6', 'spread': '11.57', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (APOE4 negatives)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.9', 'spread': '14.90', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (APOE4 positives)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '483', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.2', 'spread': '12.88', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (APOE4 positives)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.7', 'spread': '15.26', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (APOE4 E4 homozygotes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.6', 'spread': '12.16', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (APOE4 E4 homozygotes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.6', 'spread': '11.84', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (APOE4 E4 heterozygotes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.4', 'spread': '13.08', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (APOE4 E4 heterozygotes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.1', 'spread': '16.14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Week 24, 52', 'description': "DAD, assessed the ability of a participant to execute basic and instrumental activities of daily living (ADL) and leisure activities. The scale consists of 40 questions assessing basic and instrumental ADLs. This scale assesses a participant's ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item was scored as yes: 1, no: 0 and N/A: not applicable. Higher scores indicate less disability with a score of 100 indicating no disability and 0 indicating no functional ability. The percentage score was calculated as (DAD total score/total number of applicable items) \\* 100. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.", 'unitOfMeasure': 'Scores on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject (Full population). Only those participants available at the specified time points were analyzed.The analysis was done on the full population and was repeated for APOE subgroups (negatives, positives, homozygotes, heterozygotes).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score as a Function of APOE ε4 Status.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1461', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RSG XR', 'description': "Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer's disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR."}], 'classes': [{'title': 'Week 24 (Full population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '835', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '7.87', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (Full population)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '10.90', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (APOE4 negatives)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '7.26', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (APOE4 negatives)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '7.74', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (APOE4 positives)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '482', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '8.29', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (APOE4 positives)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '12.71', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (APOE4 E4 homozygotes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '7.75', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (APOE4 E4 homozygotes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '14.19', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (APOE4 E4 heterozygotes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '8.45', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (APOE4 E4 heterozygotes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '12.34', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0) and Week 24, 52', 'description': '12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability, motor disturbance, appetite, nighttime behavior. A screening question is asked about each sub-domain. If the responses to these questions=participant has problems with a particular sub-domain of behavior, the caregiver asked all the questions about that domain, rating the frequency (1=occasionally to 4=very frequently) on a 4-point scale, their severity (1=Mild to 3=Severe) on a 3-point scale, and the distress on a 5-point scale. Total score=sum of each domain score(range 0-144);higher score=greater behavioral disturbances. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject (Full population). Only those participants available at the specified time points were analyzed.The analysis was done on the full population and was repeated for APOE subgroups (negatives, positives, homozygotes, heterozygotes).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RSG XR', 'description': "Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of Acetylcholinesterase Inhibitor (AChEI) for Alzheimer's disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received oral 4 milligram (mg) once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1461'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1364'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '116'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '45'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '135'}]}, {'type': 'Still in the study at termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '974'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Exclusion criteria met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Caregiver related', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'Abnormal ECG', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'Participant refused follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Legal representative withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Unmet inclusion-exclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Investigator decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Efficacy related', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Participant died', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Participant withdrawal due to surgery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': "A open-label extension study to evaluate the long-term safety and tolerability of rosiglitazone extended-release (RSG XR) tablets in participants with mild-to moderate Alzheimer's Disease conducted in a total of 29 countries across 267 centers from 08 August 2007 to 30 May 2009.", 'preAssignmentDetails': 'Approximately 1800 participants were planned to be enrolled however a total of 1461 participants (after completing parent studies AVA102670/AVA102672) were enrolled and received open-label RSG-XR tablets.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1461', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'RSG XR (AVA102675)', 'description': "Eligible participants who completed studies AVA102670 or AVA102672 entered in this open-label extension study. Participants received open-label RSG XR throughout the treatment period as adjunctive therapy to their existing dose of AChEI for Alzheimer's disease treatment. Participants took one tablet of study medication daily in the morning with or without food. All participants received 4 mg once daily RSG XR for the first 4 weeks of the study (only for the first 4 weeks of the study). The RSG XR dose was then increased to 8 mg once daily from Week 4 through Week 52. The dose of RSG XR was reduced to 2mg once daily if the 8 mg dose was not well tolerated. Participants were not permitted to titrate back to 8 mg RSG XR."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.9', 'spread': '7.96', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '843', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '618', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '52', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '1396', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1461}}, 'statusModule': {'whyStopped': 'Based on preliminary parent study results', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'dispFirstSubmitDate': '2010-03-29', 'completionDateStruct': {'date': '2009-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-11', 'studyFirstSubmitDate': '2007-06-21', 'dispFirstSubmitQcDate': '2010-03-29', 'resultsFirstSubmitDate': '2017-09-05', 'studyFirstSubmitQcDate': '2007-06-21', 'dispFirstPostDateStruct': {'date': '2010-05-03', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-11-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-10-11', 'studyFirstPostDateStruct': {'date': '2007-06-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Any Adverse Events (AEs) and Severity of AEs', 'timeFrame': 'Up to 76 Weeks', 'description': "An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The severity of the AE'S was categorized as mild, moderate and severe. Number of participants reporting AEs during the on treatment phase of the study."}], 'secondaryOutcomes': [{'measure': 'Number Participants With Serious Adverse Events (SAEs) and Deaths', 'timeFrame': 'Up to 76 Weeks', 'description': 'A SAE is defined as any untoward medical occurrence that, at any dose results in death, is a life-threatening condition, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or a congenital anomaly or birth defect. Number of participants with SAEs and deaths were reported for treatment duration of the study.'}, {'measure': 'Number of Participants With Adverse Event of Oedema', 'timeFrame': 'Up to 76 Weeks', 'description': "Oedema was considered as adverse event of special interest (AESI). The process for AESI selection was based on RSG's pharmacologic class and relevant AEs potentially associated with RSG. The number of participants and their percentage for the adverse event of the various types of oedema were reported."}, {'measure': 'Change From Baseline in Vital Sign Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)', 'timeFrame': 'Up to 70 Weeks (including follow up)', 'description': 'Vital signs SBP and DBP were measured at each visit. All measurements were made on the participant non-dominant arm supported at heart level, using the same cuff size and same equipment. Blood pressure was measured once, after the participant sat quietly for at least 5 minutes. DBP was measured at the disappearance of Korotkoff sounds (Phase V). If the participant was a smoker or used tobacco products, a period of 30 minutes without tobacco was allowed before taking these measurements. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the blood pressure value recorded at specified visit minus the Baseline value.'}, {'measure': 'Change From Baseline in Vital Sign Heart Rate (HR)', 'timeFrame': 'Up to 70 Weeks (including follow up)', 'description': 'Vital sign HR was measured at each visit. HR was measured once, after the participant sat quietly for at least 5 minutes. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the HR at specified visit minus the Baseline value.'}, {'measure': 'Change From Baseline in Vital Sign Body Weight (BW)', 'timeFrame': 'Up to 70 Weeks (including follow up)', 'description': 'BW was measured at all visits, without shoes and wearing light clothing. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the body weight at specified visit minus the Baseline value.'}, {'measure': 'Change From Baseline in Non-fasting Measures of Lipid Metabolism Namely Total Cholesterol (TC), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Triglycerides', 'timeFrame': 'Up to 82 Weeks (including follow up)', 'description': 'The clinical chemistry data included non-fasting measures of lipid metabolism (TC,HDL,LDL,triglycerides). Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the lipids (TC,HDL,LDL,triglycerides) value recorded at specified visit minus the Baseline value.'}, {'measure': 'Number of Participants With SBP and DBP Values of Potential Clinical Concern (PCC)', 'timeFrame': 'Up to 70 Weeks (including follow up)', 'description': 'The frequency of participant vital sign sitting blood pressure was obtained to check if the values lie outside of a pre-determined reference range (RR) for SBP 90-140 mmHg, DBP 50-90 mmHg or have a change from Baseline of PCC for SBP increase from Baseline (IFB) \\>=40, decrease from Baseline (DFB) \\>= 30 for and for DBP (IFB) \\>= 30 ,DFB \\>= 20. The number of participants with values of PCC at any time on treatment (ATOT) and follow up were reported.'}, {'measure': 'Number of Participants With HR Values of PCC ATOT', 'timeFrame': 'Up to 70 Weeks (including follow up)', 'description': 'HR was measured once, after the participant sat quietly for at least 5 minutes. The frequency of participant vital sign heart rate was obtained to check if the values lie outside of a pre-determined reference range (RR) 50-100 bpm or have a change from Baseline of PCC IFB \\>=30 and DFB \\>=30. The number of participants with values of PCC including follow up were reported.'}, {'measure': 'Number of Participants With BW Values of PCC ATOT', 'timeFrame': 'Up to 70 Weeks (including follow up)', 'description': 'The frequency of participant vital sign weight was obtained to check if the values have CFB of PCC IFB \\>=7 percent. With the exception of Week 4, when participants were first titrated to the 8mg RSG XR dose, at every time point in the study where weight was measured the percentage of participants experienced an increase in BW of PCC was approximately 2 times greater than the percentage of participants experiencing an decrease in BW of PCC DFB \\>=7 percent. The number of participants with values of PCC including follow up were reported.'}, {'measure': 'Number of Participants With Hematology Parameters of PCC ATOT', 'timeFrame': 'Up to Week 82 (including follow up)', 'description': 'The hematology data included eosinophils, haematocrit, haemoglobin, lymphocytes, mean corpuscular haemoglobin (MCH), mean corpuscular volume (MCV), monocytes, platelet count, red cell distribution width (RDW), red blood cell (RBC) count, segmented neutrophils (SN), total neutrophils (TN), white blood cell (WBC) count. The number of participants with values of PCC (defined as high and low) ATOT were reported.'}, {'measure': 'Number of Participants With Clinical Chemistry Parameters (Including Lipids) of PCC ATOT', 'timeFrame': 'Up to Week 82 (including follow up)', 'description': 'The clinical chemistry data included alanine amino transferase (ALT), albumin, aldolase, asparatate amino transferase (AST), BUN/creatinine ratio, carbon dioxide(CO2) content, chloride, cholesterol, creatinine kinase (CK), creatinine, direct bilirubin (DB), gamma glutamyl transferase (GGT), glucose, glycosylated Hemoglobin (HbA1C), HDL, LDL, lactate dehydrogenase (LD), magnesium, potassium, sodium, total bilirubin (TB), triglycerides, troponin I, urea. The number of participants with values of PCC (defined as high and low) ATOT were reported.'}, {'measure': "Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) Total Score as a Function of Apolipoprotein E (APOE) ε4 Status.", 'timeFrame': 'Baseline (Week 0) and Week 24, 52', 'description': 'The 11-item ADAS-Cog assessed a range of cognitive abilities including memory, comprehension, orientation in time and place and spontaneous speech. Most items were evaluated by tests, but some were dependent on clinician ratings on a five point scale. Scores ranged from 0 to 70 with higher scores indicating greater dysfunction. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.'}, {'measure': 'Change From Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score as a Function of APOE ε4 Status.', 'timeFrame': 'Baseline (Week 0) and Week 24, 52', 'description': "The CDR-SB is a validated clinical assessment of global function in par. with Alzheimer's disease (AD). Impairment was scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or box scores, were added together to give the CDR-Sum of Boxes which ranged from 0 to 18 (severe impairment). Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point."}, {'measure': 'Change From Baseline in Mini Mental State Examination (MMSE) Total Score as a Function of APOE ε4 Status.', 'timeFrame': 'Baseline (Week 0) and Week 24, 52', 'description': 'The MMSE consisted of 11 tests of orientation, memory (recent and immediate), concentration, language and praxis. Scores ranged from 0 to 30, with lower scores indicating greater cognitive impairment. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.'}, {'measure': 'Change From Baseline in Disability Assessment for Dementia Scale (DAD) Total Score as a Function of APOE ε4 Status.', 'timeFrame': 'Baseline (Week 0) and Week 24, 52', 'description': "DAD, assessed the ability of a participant to execute basic and instrumental activities of daily living (ADL) and leisure activities. The scale consists of 40 questions assessing basic and instrumental ADLs. This scale assesses a participant's ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item was scored as yes: 1, no: 0 and N/A: not applicable. Higher scores indicate less disability with a score of 100 indicating no disability and 0 indicating no functional ability. The percentage score was calculated as (DAD total score/total number of applicable items) \\* 100. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point."}, {'measure': 'Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score as a Function of APOE ε4 Status.', 'timeFrame': 'Baseline (Week 0) and Week 24, 52', 'description': '12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability, motor disturbance, appetite, nighttime behavior. A screening question is asked about each sub-domain. If the responses to these questions=participant has problems with a particular sub-domain of behavior, the caregiver asked all the questions about that domain, rating the frequency (1=occasionally to 4=very frequently) on a 4-point scale, their severity (1=Mild to 3=Severe) on a 3-point scale, and the distress on a 5-point scale. Total score=sum of each domain score(range 0-144);higher score=greater behavioral disturbances. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication (Week 0). Change from Baseline was calculated as the Baseline value minus the value at the specified time point.'}]}, 'conditionsModule': {'keywords': ['cognition', "Alzheimer's disease", 'Rosiglitazone extended-release (XR)', 'safety', 'adjunctive therapy', 'BRL-049653', 'tolerability', 'open-label extension'], 'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'availIpds': [{'id': 'AVA102675', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'AVA102675', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'AVA102675', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'AVA102675', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'AVA102675', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'AVA102675', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'AVA102675', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '21592048', 'type': 'BACKGROUND', 'citation': "Harrington C, Sawchak S, Chiang C, Davies J, Donovan C, Saunders AM, Irizarry M, Jeter B, Zvartau-Hind M, van Dyck CH, Gold M. Rosiglitazone does not improve cognition or global function when used as adjunctive therapy to AChE inhibitors in mild-to-moderate Alzheimer's disease: two phase 3 studies. Curr Alzheimer Res. 2011 Aug;8(5):592-606. doi: 10.2174/156720511796391935."}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': "This is a Phase III, multicenter, open-label extension, single-group study in male and female outpatients with mild-to-moderate Alzheimer's disease (AD) who have completed either AVA102670 or AVA102672. All subjects will receive rosiglitazone extended-release (RSG XR) 4mg once daily for the first 4 weeks of the study followed by 8mg RSG XR as adjunctive therapy to their existing dose of acetylcholinesterase inhibitor. Subject participation will last until one of 5 conditions applies. After a 52-week open-label treatment phase, subjects will attend a final Follow-Up Visit 6 weeks after the end of treatment. The primary objective of this study is to evaluate the long-term safety and tolerability of RSG XR in subjects with mild-to-moderate AD who have completed either AVA102670 or AVA102672. The secondary objective of this study is to explore further the long-term efficacy of RSG XR in terms of cognitive function and overall clinical response as a function of apolipoprotein E (APOE) e4 allele status."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '91 Years', 'minimumAge': '51 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Successful completion of AVA102670 or AVA102672 without safety or tolerability issues. Regular caregiver.\n\nExclusion criteria:\n\n* Congestive Heart Failure (NYHA 1-4), clinically significant peripheral edema, other neurological conditions that might disqualify participation. 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