Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-29 @ 9:06 PM
Study NCT ID:
NCT00752232
Status:
COMPLETED
Last Update Posted:
2016-01-01
First Post:
2008-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Evaluating ACC-001 in Japanese Patients With Mild To Moderate Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000603458', 'term': 'vanutide cridificar'}, {'id': 'C078785', 'term': 'saponin QA-21V1'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'ACC-001 3 Micrograms +QS-21', 'description': 'A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'ACC-001 10 Micrograms', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'ACC-001 10 Micrograms + QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day\n\n1, month 3, 6, 9 and 12', 'otherNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'ACC-001 30 Micrograms', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 3, 6, 9 and 12', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'ACC-001 30 Micrograms + QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12', 'otherNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'QS-21', 'description': 'A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Phosphate Buffered Saline (PBS)', 'description': 'A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12', 'otherNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Eyelid ptosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Colonic polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Duodenal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Tongue haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Allergy to arthropod sting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Anxiety postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 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'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 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'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypertonic bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nephrocalcinosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Aortic calcification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cholecystitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Treatment-emergent Adverse Events (AEs) by Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'ACC-001 3 Micrograms +QS-21', 'description': 'A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'OG001', 'title': 'ACC-001 10 Micrograms', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12'}, {'id': 'OG002', 'title': 'ACC-001 10 Micrograms + QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day1, month 3, 6, 9 and 12'}, {'id': 'OG003', 'title': 'ACC-001 30 Micrograms', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'OG004', 'title': 'ACC-001 30 Micrograms +QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'OG005', 'title': 'QS-21', 'description': 'A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'OG006', 'title': 'Phosphate Buffered Saline (PBS)', 'description': 'A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12'}], 'classes': [{'title': 'Mild', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 24 months', 'description': "Number of participants who experienced mild, moderate, or severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'ACC-001 3 Micrograms +QS-21', 'description': 'A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'OG001', 'title': 'ACC-001 10 Micrograms', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12'}, {'id': 'OG002', 'title': 'ACC-001 10 Micrograms + QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day1, month 3, 6, 9 and 12'}, {'id': 'OG003', 'title': 'ACC-001 30 Micrograms', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'OG004', 'title': 'ACC-001 30 Micrograms +QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'OG005', 'title': 'QS-21', 'description': 'A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'OG006', 'title': 'Phosphate Buffered Saline (PBS)', 'description': 'A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12'}], 'classes': [{'title': 'Abnormal-inconsistent with AD', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Abnormal-consistent with AD', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 24 months', 'description': 'Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormalities in Neurological Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'ACC-001 3 Micrograms +QS-21', 'description': 'A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'OG001', 'title': 'ACC-001 10 Micrograms', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12'}, {'id': 'OG002', 'title': 'ACC-001 10 Micrograms + QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'OG003', 'title': 'ACC-001 30 Micrograms', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'OG004', 'title': 'ACC-001 30 Micrograms +QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'OG005', 'title': 'QS-21', 'description': 'A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'OG006', 'title': 'Phosphate Buffered Saline (PBS)', 'description': 'A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12'}], 'classes': [{'title': 'Total', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Mental Status', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Speech', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Cranial Nerves', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Visual field', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Sensory', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Motor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Coordination', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Gait', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Primitive reflexes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Tendon reflexes', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Romberg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 24 months', 'description': 'Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerves (including pupil equality and reactivity), Visual field, Sensory, Motor, Coordination, Gait, Primitive reflexes, Tendon reflexes and Romberg.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Anti-a-beta IgG Titer at Specified Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'ACC-001 3 Micrograms +QS-21', 'description': 'A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'OG001', 'title': 'ACC-001 10 Micrograms', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12'}, {'id': 'OG002', 'title': 'ACC-001 10 Micrograms + QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'OG003', 'title': 'ACC-001 30 Micrograms', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'OG004', 'title': 'ACC-001 30 Micrograms +QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'OG005', 'title': 'QS-21', 'description': 'A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'OG006', 'title': 'Phosphate Buffered Saline (PBS)', 'description': 'A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12'}], 'classes': [{'title': 'Pre-study (n=6, 6, 6, 6, 6, 6, 4)', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '50.0', 'groupId': 'OG002', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 2 (n=6, 6, 6, 6, 6, 6, 4)', 'categories': [{'measurements': [{'value': '62.3', 'groupId': 'OG000', 'lowerLimit': '35.4', 'upperLimit': '110.0'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '86.1', 'groupId': 'OG002', 'lowerLimit': '21.3', 'upperLimit': '347.9'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 6 (n=6, 6, 6, 6, 6, 6, 4)', 'categories': [{'measurements': [{'value': '65.3', 'groupId': 'OG000', 'lowerLimit': '32.9', 'upperLimit': '129.7'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '105.4', 'groupId': 'OG002', 'lowerLimit': '43.4', 'upperLimit': '255.8'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '58.9', 'groupId': 'OG004', 'lowerLimit': '38.7', 'upperLimit': '89.5'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 10 (n=6, 6, 5, 6, 6, 6, 4)', 'categories': [{'measurements': [{'value': '70.9', 'groupId': 'OG000', 'lowerLimit': '28.9', 'upperLimit': '174.4'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '93.5', 'groupId': 'OG002', 'lowerLimit': '28.8', 'upperLimit': '303.0'}, {'value': '59.2', 'groupId': 'OG003', 'lowerLimit': '38.3', 'upperLimit': '91.5'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 14 (n=6, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '2468.3', 'groupId': 'OG000', 'lowerLimit': '775.0', 'upperLimit': '7861.2'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '8976.5', 'groupId': 'OG002', 'lowerLimit': '680.6', 'upperLimit': '118398.0'}, {'value': '163.7', 'groupId': 'OG003', 'lowerLimit': '29.5', 'upperLimit': '908.5'}, {'value': '2166.0', 'groupId': 'OG004', 'lowerLimit': '390.7', 'upperLimit': '12007.0'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 16 (n=6, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '1383.1', 'groupId': 'OG000', 'lowerLimit': '340.9', 'upperLimit': '5612.4'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '4886.1', 'groupId': 'OG002', 'lowerLimit': '348.5', 'upperLimit': '68510.7'}, {'value': '135.9', 'groupId': 'OG003', 'lowerLimit': '25.6', 'upperLimit': '720.8'}, {'value': '1506.4', 'groupId': 'OG004', 'lowerLimit': '297.6', 'upperLimit': '7623.9'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 24 (n=6, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '476.2', 'groupId': 'OG000', 'lowerLimit': '54.7', 'upperLimit': '4148.3'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '1427.3', 'groupId': 'OG002', 'lowerLimit': '80.1', 'upperLimit': '25425.0'}, {'value': '113.4', 'groupId': 'OG003', 'lowerLimit': '29.4', 'upperLimit': '436.7'}, {'value': '518.9', 'groupId': 'OG004', 'lowerLimit': '91.4', 'upperLimit': '2938.6'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 28 (n=6, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '3025.4', 'groupId': 'OG000', 'lowerLimit': '1089.9', 'upperLimit': '8398.6'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '6815.7', 'groupId': 'OG002', 'lowerLimit': '180.5', 'upperLimit': '257414.9'}, {'value': '324.6', 'groupId': 'OG003', 'lowerLimit': '28.3', 'upperLimit': '3728.9'}, {'value': '7088.0', 'groupId': 'OG004', 'lowerLimit': '1939.0', 'upperLimit': '25910.8'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 30 (n=6, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '2340.1', 'groupId': 'OG000', 'lowerLimit': '715.0', 'upperLimit': '7659.1'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '6016.6', 'groupId': 'OG002', 'lowerLimit': '190.4', 'upperLimit': '190127.4'}, {'value': '287.6', 'groupId': 'OG003', 'lowerLimit': '24.6', 'upperLimit': '3359.6'}, {'value': '5989.4', 'groupId': 'OG004', 'lowerLimit': '1366.6', 'upperLimit': '26250.5'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 34 (n=6, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '1689.7', 'groupId': 'OG000', 'lowerLimit': '371.7', 'upperLimit': '7681.8'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '5482.8', 'groupId': 'OG002', 'lowerLimit': '194.8', 'upperLimit': '154346.1'}, {'value': '214.7', 'groupId': 'OG003', 'lowerLimit': '26.1', 'upperLimit': '1765.7'}, {'value': '3730.2', 'groupId': 'OG004', 'lowerLimit': '885.6', 'upperLimit': '15711.5'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 38 (n=6, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '4806.1', 'groupId': 'OG000', 'lowerLimit': '2395.8', 'upperLimit': '9641.1'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '5751.3', 'groupId': 'OG002', 'lowerLimit': '301.4', 'upperLimit': '109732.2'}, {'value': '353.5', 'groupId': 'OG003', 'lowerLimit': '33.0', 'upperLimit': '3785.7'}, {'value': '10540.9', 'groupId': 'OG004', 'lowerLimit': '3111.3', 'upperLimit': '35711.8'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 40 (n=6, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '5147.1', 'groupId': 'OG000', 'lowerLimit': '2523.9', 'upperLimit': '10496.7'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '4215.3', 'groupId': 'OG002', 'lowerLimit': '174.2', 'upperLimit': '101984.8'}, {'value': '288.1', 'groupId': 'OG003', 'lowerLimit': '32.2', 'upperLimit': '2573.6'}, {'value': '8889.6', 'groupId': 'OG004', 'lowerLimit': '2565.3', 'upperLimit': '30805.1'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 50 (n=6, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '2083.4', 'groupId': 'OG000', 'lowerLimit': '1077.9', 'upperLimit': '4026.8'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '2792.0', 'groupId': 'OG002', 'lowerLimit': '144.6', 'upperLimit': '53925.7'}, {'value': '162.0', 'groupId': 'OG003', 'lowerLimit': '31.3', 'upperLimit': '839.0'}, {'value': '4184.8', 'groupId': 'OG004', 'lowerLimit': '921.0', 'upperLimit': '19015.0'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 54 (n=4, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '7028.9', 'groupId': 'OG000', 'lowerLimit': '1100.8', 'upperLimit': '44879.8'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '4316.0', 'groupId': 'OG002', 'lowerLimit': '312.0', 'upperLimit': '59700.9'}, {'value': '467.9', 'groupId': 'OG003', 'lowerLimit': '81.4', 'upperLimit': '2689.7'}, {'value': '12638.9', 'groupId': 'OG004', 'lowerLimit': '5577.9', 'upperLimit': '28638.3'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 56 (n=4, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '7274.7', 'groupId': 'OG000', 'lowerLimit': '1037.3', 'upperLimit': '51016.9'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '3642.5', 'groupId': 'OG002', 'lowerLimit': '175.7', 'upperLimit': '75527.4'}, {'value': '372.7', 'groupId': 'OG003', 'lowerLimit': '78.5', 'upperLimit': '1769.7'}, {'value': '8644.2', 'groupId': 'OG004', 'lowerLimit': '3365.0', 'upperLimit': '22205.8'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 66 (n=5, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '3841.6', 'groupId': 'OG000', 'lowerLimit': '825.2', 'upperLimit': '17883.9'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '3069.8', 'groupId': 'OG002', 'lowerLimit': '165.5', 'upperLimit': '56949.5'}, {'value': '207.0', 'groupId': 'OG003', 'lowerLimit': '46.8', 'upperLimit': '915.6'}, {'value': '4555.6', 'groupId': 'OG004', 'lowerLimit': '1016.8', 'upperLimit': '20411.1'}, {'value': '147.9', 'groupId': 'OG005', 'lowerLimit': '7.3', 'upperLimit': '3006.4'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 78 (n=4, 6, 5, 5, 6, 5, 4)', 'categories': [{'measurements': [{'value': '2599.1', 'groupId': 'OG000', 'lowerLimit': '215.5', 'upperLimit': '31342.0'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '2236.1', 'groupId': 'OG002', 'lowerLimit': '155.3', 'upperLimit': '32198.4'}, {'value': '231.0', 'groupId': 'OG003', 'lowerLimit': '34.2', 'upperLimit': '1559.2'}, {'value': '2484.6', 'groupId': 'OG004', 'lowerLimit': '571.3', 'upperLimit': '10806.5'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 91 (n=4, 0, 1, 0, 0, 1, 0)', 'categories': [{'measurements': [{'value': '1870.6', 'groupId': 'OG000', 'lowerLimit': '159.8', 'upperLimit': '21900.7'}, {'value': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2959.0', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '50.0', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Week 104 (n=4, 0, 1, 0, 0, 1, 0)', 'categories': [{'measurements': [{'value': '1403.1', 'groupId': 'OG000', 'lowerLimit': '112.1', 'upperLimit': '17561.2'}, {'value': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2557.0', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '50.0', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline up to 24 months', 'description': 'Geometric mean of anti-a-beta IgG titer from pre-study through Week 104', 'unitOfMeasure': 'Units/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The population for immunogenicity analysis includes all of the randomly assigned participants who took at least one dose of study medication, having the baseline and at least one post baseline immunogenicity evaluation.'}, {'type': 'SECONDARY', 'title': 'Anti-a-beta IgM Titer at Specified Visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'ACC-001 3 Micrograms +QS-21', 'description': 'A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'OG001', 'title': 'ACC-001 10 Micrograms', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12'}, {'id': 'OG002', 'title': 'ACC-001 10 Micrograms + QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'OG003', 'title': 'ACC-001 30 Micrograms', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'OG004', 'title': 'ACC-001 30 Micrograms +QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'OG005', 'title': 'QS-21', 'description': 'A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'OG006', 'title': 'Phosphate Buffered Saline (PBS)', 'description': 'A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12'}], 'classes': [{'title': 'Pre-study (n=6, 6, 6, 6, 6, 6, 4)', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '25.0', 'upperLimit': '25.0'}, {'value': '31.7', 'groupId': 'OG001', 'lowerLimit': '17.3', 'upperLimit': '58.1'}, {'value': '25.0', 'groupId': 'OG002', 'lowerLimit': '25.0', 'upperLimit': '25.0'}, {'value': '32.9', 'groupId': 'OG003', 'lowerLimit': '16.3', 'upperLimit': '66.4'}, {'value': '31.0', 'groupId': 'OG004', 'lowerLimit': '17.8', 'upperLimit': '53.9'}, {'value': '36.1', 'groupId': 'OG005', 'lowerLimit': '14.0', 'upperLimit': '93.2'}, {'value': '37.6', 'groupId': 'OG006', 'lowerLimit': '10.3', 'upperLimit': '137.9'}]}]}, {'title': 'Week 2 (n=6, 6, 6, 6, 6, 6, 4)', 'categories': [{'measurements': [{'value': '38.0', 'groupId': 'OG000', 'lowerLimit': '17.5', 'upperLimit': '82.6'}, {'value': '32.5', 'groupId': 'OG001', 'lowerLimit': '16.5', 'upperLimit': '63.9'}, {'value': '56.6', 'groupId': 'OG002', 'lowerLimit': '13.9', 'upperLimit': '231.4'}, {'value': '32.1', 'groupId': 'OG003', 'lowerLimit': '16.9', 'upperLimit': '60.7'}, {'value': '116.6', 'groupId': 'OG004', 'lowerLimit': '26.6', 'upperLimit': '511.8'}, {'value': '40.9', 'groupId': 'OG005', 'lowerLimit': '16.2', 'upperLimit': '103.2'}, {'value': '38.0', 'groupId': 'OG006', 'lowerLimit': '10.0', 'upperLimit': '144.7'}]}]}, {'title': 'Week 6 (n=6, 6, 6, 6, 6, 6, 4)', 'categories': [{'measurements': [{'value': '51.0', 'groupId': 'OG000', 'lowerLimit': '15.9', 'upperLimit': '163.5'}, {'value': '34.9', 'groupId': 'OG001', 'lowerLimit': '19.5', 'upperLimit': '62.5'}, {'value': '51.1', 'groupId': 'OG002', 'lowerLimit': '15.8', 'upperLimit': '165.2'}, {'value': '37.9', 'groupId': 'OG003', 'lowerLimit': '18.7', 'upperLimit': '77.0'}, {'value': '123.0', 'groupId': 'OG004', 'lowerLimit': '25.9', 'upperLimit': '584.8'}, {'value': '41.2', 'groupId': 'OG005', 'lowerLimit': '16.2', 'upperLimit': '105.1'}, {'value': '37.3', 'groupId': 'OG006', 'lowerLimit': '10.4', 'upperLimit': '133.4'}]}]}, {'title': 'Week 10 (n=6, 6, 5, 6, 6, 6, 4)', 'categories': [{'measurements': [{'value': '53.7', 'groupId': 'OG000', 'lowerLimit': '15.4', 'upperLimit': '188.0'}, {'value': '35.4', 'groupId': 'OG001', 'lowerLimit': '19.5', 'upperLimit': '64.4'}, {'value': '58.6', 'groupId': 'OG002', 'lowerLimit': '13.7', 'upperLimit': '251.3'}, {'value': '32.1', 'groupId': 'OG003', 'lowerLimit': '16.9', 'upperLimit': '61.0'}, {'value': '128.4', 'groupId': 'OG004', 'lowerLimit': '30.2', 'upperLimit': '546.2'}, {'value': '40.5', 'groupId': 'OG005', 'lowerLimit': '17.3', 'upperLimit': '94.9'}, {'value': '37.4', 'groupId': 'OG006', 'lowerLimit': '10.4', 'upperLimit': '134.5'}]}]}, {'title': 'Week 14 (n=6, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '395.6', 'groupId': 'OG000', 'lowerLimit': '12.8', 'upperLimit': '12238.1'}, {'value': '38.3', 'groupId': 'OG001', 'lowerLimit': '18.9', 'upperLimit': '77.5'}, {'value': '357.1', 'groupId': 'OG002', 'lowerLimit': '43.7', 'upperLimit': '2920.6'}, {'value': '52.6', 'groupId': 'OG003', 'lowerLimit': '20.7', 'upperLimit': '133.5'}, {'value': '614.7', 'groupId': 'OG004', 'lowerLimit': '125.8', 'upperLimit': '3002.9'}, {'value': '47.7', 'groupId': 'OG005', 'lowerLimit': '14.9', 'upperLimit': '153.3'}, {'value': '97.1', 'groupId': 'OG006', 'lowerLimit': '1.3', 'upperLimit': '7277.6'}]}]}, {'title': 'Week 16 (n=6, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '380.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '15415.0'}, {'value': '37.6', 'groupId': 'OG001', 'lowerLimit': '19.3', 'upperLimit': '73.2'}, {'value': '330.1', 'groupId': 'OG002', 'lowerLimit': '48.0', 'upperLimit': '2271.7'}, {'value': '57.7', 'groupId': 'OG003', 'lowerLimit': '20.7', 'upperLimit': '161.0'}, {'value': '683.8', 'groupId': 'OG004', 'lowerLimit': '80.2', 'upperLimit': '5829.6'}, {'value': '46.3', 'groupId': 'OG005', 'lowerLimit': '14.1', 'upperLimit': '152.5'}, {'value': '35.4', 'groupId': 'OG006', 'lowerLimit': '11.7', 'upperLimit': '107.6'}]}]}, {'title': 'Week 24 (n=6, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '204.0', 'groupId': 'OG000', 'lowerLimit': '4.4', 'upperLimit': '9434.1'}, {'value': '34.7', 'groupId': 'OG001', 'lowerLimit': '20.4', 'upperLimit': '59.2'}, {'value': '208.6', 'groupId': 'OG002', 'lowerLimit': '44.6', 'upperLimit': '975.7'}, {'value': '58.8', 'groupId': 'OG003', 'lowerLimit': '19.2', 'upperLimit': '180.1'}, {'value': '586.9', 'groupId': 'OG004', 'lowerLimit': '60.2', 'upperLimit': '5724.2'}, {'value': '37.1', 'groupId': 'OG005', 'lowerLimit': '12.4', 'upperLimit': '110.6'}, {'value': '35.9', 'groupId': 'OG006', 'lowerLimit': '11.4', 'upperLimit': '113.2'}]}]}, {'title': 'Week 28 (n=6, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '651.0', 'groupId': 'OG000', 'lowerLimit': '47.9', 'upperLimit': '8850.3'}, {'value': '41.4', 'groupId': 'OG001', 'lowerLimit': '17.7', 'upperLimit': '96.6'}, {'value': '356.7', 'groupId': 'OG002', 'lowerLimit': '50.9', 'upperLimit': '2501.4'}, {'value': '77.7', 'groupId': 'OG003', 'lowerLimit': '16.7', 'upperLimit': '362.3'}, {'value': '2706.8', 'groupId': 'OG004', 'lowerLimit': '366.9', 'upperLimit': '19970.2'}, {'value': '58.6', 'groupId': 'OG005', 'lowerLimit': '17.2', 'upperLimit': '199.2'}, {'value': '37.9', 'groupId': 'OG006', 'lowerLimit': '10.1', 'upperLimit': '142.4'}]}]}, {'title': 'Week 30 (n=6, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '949.1', 'groupId': 'OG000', 'lowerLimit': '88.1', 'upperLimit': '10223.9'}, {'value': '40.6', 'groupId': 'OG001', 'lowerLimit': '18.4', 'upperLimit': '89.5'}, {'value': '719.1', 'groupId': 'OG002', 'lowerLimit': '81.7', 'upperLimit': '6327.1'}, {'value': '79.0', 'groupId': 'OG003', 'lowerLimit': '17.9', 'upperLimit': '349.3'}, {'value': '3456.7', 'groupId': 'OG004', 'lowerLimit': '381.6', 'upperLimit': '31311.7'}, {'value': '47.4', 'groupId': 'OG005', 'lowerLimit': '22.9', 'upperLimit': '98.0'}, {'value': '39.4', 'groupId': 'OG006', 'lowerLimit': '9.2', 'upperLimit': '168.5'}]}]}, {'title': 'Week 34 (n=6, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '446.7', 'groupId': 'OG000', 'lowerLimit': '20.4', 'upperLimit': '9760.9'}, {'value': '38.7', 'groupId': 'OG001', 'lowerLimit': '19.0', 'upperLimit': '78.6'}, {'value': '666.0', 'groupId': 'OG002', 'lowerLimit': '80.9', 'upperLimit': '5481.4'}, {'value': '62.3', 'groupId': 'OG003', 'lowerLimit': '20.1', 'upperLimit': '192.9'}, {'value': '2182.0', 'groupId': 'OG004', 'lowerLimit': '235.7', 'upperLimit': '20199.3'}, {'value': '43.2', 'groupId': 'OG005', 'lowerLimit': '17.0', 'upperLimit': '109.3'}, {'value': '38.0', 'groupId': 'OG006', 'lowerLimit': '10.0', 'upperLimit': '144.7'}]}]}, {'title': 'Week 38 (n=6, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '473.5', 'groupId': 'OG000', 'lowerLimit': '32.9', 'upperLimit': '6813.1'}, {'value': '39.1', 'groupId': 'OG001', 'lowerLimit': '18.9', 'upperLimit': '80.8'}, {'value': '702.1', 'groupId': 'OG002', 'lowerLimit': '201.8', 'upperLimit': '2443.2'}, {'value': '99.2', 'groupId': 'OG003', 'lowerLimit': '24.6', 'upperLimit': '400.2'}, {'value': '2639.4', 'groupId': 'OG004', 'lowerLimit': '368.5', 'upperLimit': '18904.8'}, {'value': '48.8', 'groupId': 'OG005', 'lowerLimit': '22.1', 'upperLimit': '107.8'}, {'value': '39.4', 'groupId': 'OG006', 'lowerLimit': '9.3', 'upperLimit': '167.3'}]}]}, {'title': 'Week 40 (n=6, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '509.6', 'groupId': 'OG000', 'lowerLimit': '38.5', 'upperLimit': '6736.7'}, {'value': '38.0', 'groupId': 'OG001', 'lowerLimit': '19.2', 'upperLimit': '75.2'}, {'value': '574.8', 'groupId': 'OG002', 'lowerLimit': '192.7', 'upperLimit': '1714.8'}, {'value': '83.6', 'groupId': 'OG003', 'lowerLimit': '19.0', 'upperLimit': '367.4'}, {'value': '2545.5', 'groupId': 'OG004', 'lowerLimit': '313.6', 'upperLimit': '20661.2'}, {'value': '45.9', 'groupId': 'OG005', 'lowerLimit': '21.8', 'upperLimit': '96.6'}, {'value': '37.0', 'groupId': 'OG006', 'lowerLimit': '10.6', 'upperLimit': '128.9'}]}]}, {'title': 'Week 50 (n=6, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '223.8', 'groupId': 'OG000', 'lowerLimit': '15.2', 'upperLimit': '3301.7'}, {'value': '37.8', 'groupId': 'OG001', 'lowerLimit': '18.8', 'upperLimit': '76.1'}, {'value': '432.4', 'groupId': 'OG002', 'lowerLimit': '140.8', 'upperLimit': '1328.1'}, {'value': '71.5', 'groupId': 'OG003', 'lowerLimit': '27.0', 'upperLimit': '189.3'}, {'value': '1418.2', 'groupId': 'OG004', 'lowerLimit': '230.1', 'upperLimit': '8741.4'}, {'value': '61.2', 'groupId': 'OG005', 'lowerLimit': '29.1', 'upperLimit': '128.6'}, {'value': '38.2', 'groupId': 'OG006', 'lowerLimit': '9.9', 'upperLimit': '146.9'}]}]}, {'title': 'Week 54 (n=4, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '836.2', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '147881.4'}, {'value': '37.9', 'groupId': 'OG001', 'lowerLimit': '19.2', 'upperLimit': '74.8'}, {'value': '450.0', 'groupId': 'OG002', 'lowerLimit': '186.4', 'upperLimit': '1086.3'}, {'value': '140.9', 'groupId': 'OG003', 'lowerLimit': '25.3', 'upperLimit': '782.7'}, {'value': '1668.1', 'groupId': 'OG004', 'lowerLimit': '309.0', 'upperLimit': '9005.8'}, {'value': '51.2', 'groupId': 'OG005', 'lowerLimit': '21.4', 'upperLimit': '122.5'}, {'value': '36.5', 'groupId': 'OG006', 'lowerLimit': '10.9', 'upperLimit': '122.2'}]}]}, {'title': 'Week 56 (n=4, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '678.8', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '108248.9'}, {'value': '36.9', 'groupId': 'OG001', 'lowerLimit': '19.6', 'upperLimit': '69.6'}, {'value': '422.3', 'groupId': 'OG002', 'lowerLimit': '180.7', 'upperLimit': '986.6'}, {'value': '119.4', 'groupId': 'OG003', 'lowerLimit': '18.3', 'upperLimit': '780.5'}, {'value': '1507.7', 'groupId': 'OG004', 'lowerLimit': '309.5', 'upperLimit': '7344.5'}, {'value': '42.4', 'groupId': 'OG005', 'lowerLimit': '17.0', 'upperLimit': '105.3'}, {'value': '34.6', 'groupId': 'OG006', 'lowerLimit': '12.3', 'upperLimit': '97.6'}]}]}, {'title': 'Week 66 (n=5, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '371.0', 'groupId': 'OG000', 'lowerLimit': '16.3', 'upperLimit': '8454.7'}, {'value': '37.1', 'groupId': 'OG001', 'lowerLimit': '19.4', 'upperLimit': '71.0'}, {'value': '331.1', 'groupId': 'OG002', 'lowerLimit': '131.3', 'upperLimit': '834.6'}, {'value': '105.3', 'groupId': 'OG003', 'lowerLimit': '15.9', 'upperLimit': '698.4'}, {'value': '1058.7', 'groupId': 'OG004', 'lowerLimit': '226.9', 'upperLimit': '4939.1'}, {'value': '56.3', 'groupId': 'OG005', 'lowerLimit': '12.7', 'upperLimit': '249.0'}, {'value': '35.4', 'groupId': 'OG006', 'lowerLimit': '11.7', 'upperLimit': '106.5'}]}]}, {'title': 'Week 78 (n=4, 6, 5, 5, 6, 5, 4)', 'categories': [{'measurements': [{'value': '450.1', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '29432.6'}, {'value': '39.9', 'groupId': 'OG001', 'lowerLimit': '18.6', 'upperLimit': '85.5'}, {'value': '209.8', 'groupId': 'OG002', 'lowerLimit': '81.9', 'upperLimit': '537.8'}, {'value': '134.2', 'groupId': 'OG003', 'lowerLimit': '13.3', 'upperLimit': '1357.2'}, {'value': '759.3', 'groupId': 'OG004', 'lowerLimit': '135.9', 'upperLimit': '4242.2'}, {'value': '32.7', 'groupId': 'OG005', 'lowerLimit': '15.6', 'upperLimit': '68.5'}, {'value': '34.1', 'groupId': 'OG006', 'lowerLimit': '12.7', 'upperLimit': '92.1'}]}]}, {'title': 'Week 91 (n=4, 0, 1, 0, 0, 1, 0)', 'categories': [{'measurements': [{'value': '321.8', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '17755.5'}, {'value': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '60.0', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '25.0', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Week 104 (n=4, 0, 1, 0, 0, 1, 0)', 'categories': [{'measurements': [{'value': '226.1', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '11037.7'}, {'value': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '54.0', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '25.0', 'comment': '95% confidence interval was not estimable since only one participant was evaluable.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline up to 24 months', 'description': 'Geometric mean of anti-a-beta IgM titer from pre-study through Week 104', 'unitOfMeasure': 'Units/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The population for immunogenicity analysis includes all of the randomly assigned participants who took at least one dose of study medication, having the baseline and at least one post baseline immunogenicity evaluation.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 36, 52, 78 and 104.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'ACC-001 3 Micrograms +QS-21', 'description': 'A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'OG001', 'title': 'ACC-001 10 Micrograms', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12'}, {'id': 'OG002', 'title': 'ACC-001 10 Micrograms + QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'OG003', 'title': 'ACC-001 30 Micrograms', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'OG004', 'title': 'ACC-001 30 Micrograms +QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'OG005', 'title': 'QS-21', 'description': 'A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'OG006', 'title': 'Phosphate Buffered Saline (PBS)', 'description': 'A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12'}], 'classes': [{'title': 'Week 12 (n=6, 6, 5, 6, 6, 6, 4)', 'categories': [{'measurements': [{'value': '4.06', 'spread': '6.45', 'groupId': 'OG000'}, {'value': '-2.00', 'spread': '2.86', 'groupId': 'OG001'}, {'value': '1.93', 'spread': '5.51', 'groupId': 'OG002'}, {'value': '-0.94', 'spread': '2.72', 'groupId': 'OG003'}, {'value': '-1.28', 'spread': '3.74', 'groupId': 'OG004'}, {'value': '1.28', 'spread': '4.95', 'groupId': 'OG005'}, {'value': '2.92', 'spread': '1.13', 'groupId': 'OG006'}]}]}, {'title': 'Week 26 (n=6, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '2.22', 'spread': '4.88', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '4.63', 'groupId': 'OG001'}, {'value': '-1.20', 'spread': '1.17', 'groupId': 'OG002'}, {'value': '1.67', 'spread': '4.30', 'groupId': 'OG003'}, {'value': '-1.78', 'spread': '2.45', 'groupId': 'OG004'}, {'value': '1.93', 'spread': '9.59', 'groupId': 'OG005'}, {'value': '1.33', 'spread': '3.27', 'groupId': 'OG006'}]}]}, {'title': 'Week 36 (n=6, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '4.89', 'spread': '7.53', 'groupId': 'OG000'}, {'value': '-0.50', 'spread': '2.75', 'groupId': 'OG001'}, {'value': '-0.93', 'spread': '1.53', 'groupId': 'OG002'}, {'value': '0.56', 'spread': '3.94', 'groupId': 'OG003'}, {'value': '-1.17', 'spread': '4.88', 'groupId': 'OG004'}, {'value': '2.93', 'spread': '5.08', 'groupId': 'OG005'}, {'value': '3.92', 'spread': '4.15', 'groupId': 'OG006'}]}]}, {'title': 'Week 52 (n=6, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '5.83', 'spread': '9.41', 'groupId': 'OG000'}, {'value': '-2.56', 'spread': '4.18', 'groupId': 'OG001'}, {'value': '-1.73', 'spread': '2.24', 'groupId': 'OG002'}, {'value': '3.56', 'spread': '4.81', 'groupId': 'OG003'}, {'value': '-2.00', 'spread': '3.75', 'groupId': 'OG004'}, {'value': '5.80', 'spread': '7.39', 'groupId': 'OG005'}, {'value': '0.92', 'spread': '2.60', 'groupId': 'OG006'}]}]}, {'title': 'Week 78 (n=4, 6, 5, 5, 6, 5, 4)', 'categories': [{'measurements': [{'value': '8.50', 'spread': '10.09', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '3.03', 'groupId': 'OG001'}, {'value': '-0.07', 'spread': '4.23', 'groupId': 'OG002'}, {'value': '2.47', 'spread': '3.90', 'groupId': 'OG003'}, {'value': '-0.06', 'spread': '5.16', 'groupId': 'OG004'}, {'value': '6.47', 'spread': '12.32', 'groupId': 'OG005'}, {'value': '4.50', 'spread': '4.39', 'groupId': 'OG006'}]}]}, {'title': 'Week 104 (n=4, 0 1, 0, 0, 1, 0)', 'categories': [{'measurements': [{'value': '5.92', 'spread': '8.86', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG001'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG004'}, {'value': '6.33', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 24 months', 'description': 'The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility. For this stuy, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11. Total score ranges from 0 to 70 points, with higher scores indicating a greater degree of impairment.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 36, 52, 78 and 104.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'ACC-001 3 Micrograms +QS-21', 'description': 'A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'OG001', 'title': 'ACC-001 10 Micrograms', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12'}, {'id': 'OG002', 'title': 'ACC-001 10 Micrograms + QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'OG003', 'title': 'ACC-001 30 Micrograms', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'OG004', 'title': 'ACC-001 30 Micrograms +QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'OG005', 'title': 'QS-21', 'description': 'A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'OG006', 'title': 'Phosphate Buffered Saline (PBS)', 'description': 'A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12'}], 'classes': [{'title': 'Week 12 (n=4, 5, 4, 6, 5, 5, 4)', 'categories': [{'measurements': [{'value': '0.8', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '3.6', 'groupId': 'OG001'}, {'value': '5.1', 'spread': '7.4', 'groupId': 'OG002'}, {'value': '-3.5', 'spread': '7.0', 'groupId': 'OG003'}, {'value': '-3.0', 'spread': '11.8', 'groupId': 'OG004'}, {'value': '-8.8', 'spread': '10.8', 'groupId': 'OG005'}, {'value': '3.9', 'spread': '6.8', 'groupId': 'OG006'}]}]}, {'title': 'Week 26 (n=4, 4, 4, 6, 5, 5, 4)', 'categories': [{'measurements': [{'value': '2.1', 'spread': '9.5', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '5.3', 'groupId': 'OG001'}, {'value': '6.8', 'spread': '6.8', 'groupId': 'OG002'}, {'value': '-1.8', 'spread': '6.9', 'groupId': 'OG003'}, {'value': '-0.6', 'spread': '3.3', 'groupId': 'OG004'}, {'value': '-5.4', 'spread': '13.2', 'groupId': 'OG005'}, {'value': '4.1', 'spread': '16.0', 'groupId': 'OG006'}]}]}, {'title': 'Week 36 (n=4, 4, 5, 6, 5, 5, 4)', 'categories': [{'measurements': [{'value': '1.4', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '6.9', 'groupId': 'OG001'}, {'value': '3.7', 'spread': '4.4', 'groupId': 'OG002'}, {'value': '-2.7', 'spread': '6.3', 'groupId': 'OG003'}, {'value': '-1.7', 'spread': '9.3', 'groupId': 'OG004'}, {'value': '-6.8', 'spread': '11.5', 'groupId': 'OG005'}, {'value': '-1.4', 'spread': '15.1', 'groupId': 'OG006'}]}]}, {'title': 'Week 52 (n=4, 5, 5, 6, 5, 5, 4)', 'categories': [{'measurements': [{'value': '-7.8', 'spread': '15.6', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '21.7', 'groupId': 'OG001'}, {'value': '4.2', 'spread': '5.3', 'groupId': 'OG002'}, {'value': '-8.3', 'spread': '21.0', 'groupId': 'OG003'}, {'value': '0.8', 'spread': '16.1', 'groupId': 'OG004'}, {'value': '-11.4', 'spread': '9.1', 'groupId': 'OG005'}, {'value': '2.8', 'spread': '10.4', 'groupId': 'OG006'}]}]}, {'title': 'Week 78 (n=2, 5, 4, 5, 5, 5, 4)', 'categories': [{'measurements': [{'value': '-12.0', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '-16.7', 'spread': '26.5', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '9.0', 'groupId': 'OG002'}, {'value': '-2.9', 'spread': '9.7', 'groupId': 'OG003'}, {'value': '-1.0', 'spread': '12.4', 'groupId': 'OG004'}, {'value': '-14.4', 'spread': '10.0', 'groupId': 'OG005'}, {'value': '3.4', 'spread': '9.3', 'groupId': 'OG006'}]}]}, {'title': 'Week 104 (n=2, 0, 1, 0, 0, 1, 0)', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.2', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG001'}, {'value': '0.0', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG004'}, {'value': '-32.5', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 24 months', 'description': 'The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores represent less disability in ADL while lower scores indicate more dysfunction.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 36, 52, 78 and 104.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'ACC-001 3 Micrograms +QS-21', 'description': 'A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'OG001', 'title': 'ACC-001 10 Micrograms', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12'}, {'id': 'OG002', 'title': 'ACC-001 10 Micrograms + QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'OG003', 'title': 'ACC-001 30 Micrograms', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'OG004', 'title': 'ACC-001 30 Micrograms +QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'OG005', 'title': 'QS-21', 'description': 'A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'OG006', 'title': 'Phosphate Buffered Saline (PBS)', 'description': 'A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12'}], 'classes': [{'title': 'Week 12 (n=6, 6, 5, 6, 6, 6, 4)', 'categories': [{'measurements': [{'value': '0.048', 'spread': '0.314', 'groupId': 'OG000'}, {'value': '0.002', 'spread': '0.198', 'groupId': 'OG001'}, {'value': '0.043', 'spread': '0.306', 'groupId': 'OG002'}, {'value': '0.030', 'spread': '0.220', 'groupId': 'OG003'}, {'value': '-0.007', 'spread': '0.266', 'groupId': 'OG004'}, {'value': '0.058', 'spread': '0.226', 'groupId': 'OG005'}, {'value': '0.203', 'spread': '0.092', 'groupId': 'OG006'}]}]}, {'title': 'Week 26 (n=6, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '0.114', 'spread': '0.378', 'groupId': 'OG000'}, {'value': '-0.028', 'spread': '0.420', 'groupId': 'OG001'}, {'value': '0.272', 'spread': '0.148', 'groupId': 'OG002'}, {'value': '0.095', 'spread': '0.404', 'groupId': 'OG003'}, {'value': '0.374', 'spread': '0.278', 'groupId': 'OG004'}, {'value': '0.121', 'spread': '0.180', 'groupId': 'OG005'}, {'value': '0.215', 'spread': '0.449', 'groupId': 'OG006'}]}]}, {'title': 'Week 36 (n=6, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '0.148', 'spread': '0.573', 'groupId': 'OG000'}, {'value': '0.188', 'spread': '0.219', 'groupId': 'OG001'}, {'value': '0.367', 'spread': '0.222', 'groupId': 'OG002'}, {'value': '0.267', 'spread': '0.294', 'groupId': 'OG003'}, {'value': '0.232', 'spread': '0.388', 'groupId': 'OG004'}, {'value': '0.061', 'spread': '0.353', 'groupId': 'OG005'}, {'value': '0.465', 'spread': '0.494', 'groupId': 'OG006'}]}]}, {'title': 'Week 52 (n=6, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '0.171', 'spread': '0.585', 'groupId': 'OG000'}, {'value': '0.183', 'spread': '0.274', 'groupId': 'OG001'}, {'value': '0.247', 'spread': '0.189', 'groupId': 'OG002'}, {'value': '-0.036', 'spread': '0.312', 'groupId': 'OG003'}, {'value': '0.255', 'spread': '0.454', 'groupId': 'OG004'}, {'value': '0.184', 'spread': '0.320', 'groupId': 'OG005'}, {'value': '0.411', 'spread': '0.357', 'groupId': 'OG006'}]}]}, {'title': 'Week 78 (n=4, 6, 5, 5, 6, 5, 4)', 'categories': [{'measurements': [{'value': '0.138', 'spread': '0.597', 'groupId': 'OG000'}, {'value': '-0.047', 'spread': '0.291', 'groupId': 'OG001'}, {'value': '0.132', 'spread': '0.261', 'groupId': 'OG002'}, {'value': '-0.160', 'spread': '0.332', 'groupId': 'OG003'}, {'value': '0.246', 'spread': '0.515', 'groupId': 'OG004'}, {'value': '0.184', 'spread': '0.631', 'groupId': 'OG005'}, {'value': '0.258', 'spread': '0.399', 'groupId': 'OG006'}]}]}, {'title': 'Week 104 (n=4, 0, 1, 0, 0, 1, 0)', 'categories': [{'measurements': [{'value': '0.048', 'spread': '0.647', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG001'}, {'value': '0.345', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG004'}, {'value': '0.118', 'spread': '0.118', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 24 months', 'description': "The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function. The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMSVerbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test. The NTB z-score is used for analysis. The z-score for each component is calculated through the following formula: z = (y\\_visit - y\\_base)/SD\\_base, where y\\_visit is a value at a particular time point and y\\_base is the average test score, and SD\\_base is the SD based on all participants' observed baseline scores in the study.", 'unitOfMeasure': 'Z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 36, 40, 52, 78 and 104.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'ACC-001 3 Micrograms +QS-21', 'description': 'A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'OG001', 'title': 'ACC-001 10 Micrograms', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12'}, {'id': 'OG002', 'title': 'ACC-001 10 Micrograms + QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'OG003', 'title': 'ACC-001 30 Micrograms', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'OG004', 'title': 'ACC-001 30 Micrograms +QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'OG005', 'title': 'QS-21', 'description': 'A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'OG006', 'title': 'Phosphate Buffered Saline (PBS)', 'description': 'A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12'}], 'classes': [{'title': 'Week 4 (n=6, 6, 5, 6, 6, 6, 4)', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '2.7', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '2.5', 'groupId': 'OG002'}, {'value': '1.0', 'spread': '1.7', 'groupId': 'OG003'}, {'value': '1.5', 'spread': '2.4', 'groupId': 'OG004'}, {'value': '1.0', 'spread': '2.1', 'groupId': 'OG005'}, {'value': '1.0', 'spread': '2.4', 'groupId': 'OG006'}]}]}, {'title': 'Week 8 (n=6, 6, 5, 6, 6, 6, 4)', 'categories': [{'measurements': [{'value': '0.5', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '2.8', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '2.5', 'groupId': 'OG002'}, {'value': '1.8', 'spread': '1.6', 'groupId': 'OG003'}, {'value': '2.0', 'spread': '1.7', 'groupId': 'OG004'}, {'value': '1.0', 'spread': '2.7', 'groupId': 'OG005'}, {'value': '-0.3', 'spread': '1.7', 'groupId': 'OG006'}]}]}, {'title': 'Week 12 (n=6, 6, 5, 6, 6, 6, 4)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '2.7', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '2.5', 'groupId': 'OG002'}, {'value': '0.8', 'spread': '2.1', 'groupId': 'OG003'}, {'value': '2.3', 'spread': '2.9', 'groupId': 'OG004'}, {'value': '0.7', 'spread': '2.2', 'groupId': 'OG005'}, {'value': '0.5', 'spread': '2.4', 'groupId': 'OG006'}]}]}, {'title': 'Week 16 (n=6, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '2.9', 'groupId': 'OG002'}, {'value': '2.8', 'spread': '1.6', 'groupId': 'OG003'}, {'value': '1.2', 'spread': '3.1', 'groupId': 'OG004'}, {'value': '1.0', 'spread': '4.3', 'groupId': 'OG005'}, {'value': '0.3', 'spread': '3.2', 'groupId': 'OG006'}]}]}, {'title': 'Week 26 (n=6, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '0.4', 'spread': '3.6', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '1.5', 'groupId': 'OG003'}, {'value': '0.2', 'spread': '2.9', 'groupId': 'OG004'}, {'value': '0.2', 'spread': '2.8', 'groupId': 'OG005'}, {'value': '0.5', 'spread': '3.1', 'groupId': 'OG006'}]}]}, {'title': 'Week 30 (n=6, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '4.3', 'groupId': 'OG002'}, {'value': '1.2', 'spread': '1.3', 'groupId': 'OG003'}, {'value': '1.3', 'spread': '2.2', 'groupId': 'OG004'}, {'value': '1.4', 'spread': '4.1', 'groupId': 'OG005'}, {'value': '0.3', 'spread': '2.1', 'groupId': 'OG006'}]}]}, {'title': 'Week 36 (n=6, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '-3.0', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '2.9', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '2.3', 'groupId': 'OG002'}, {'value': '0.8', 'spread': '1.6', 'groupId': 'OG003'}, {'value': '2.2', 'spread': '2.8', 'groupId': 'OG004'}, {'value': '-0.2', 'spread': '2.2', 'groupId': 'OG005'}, {'value': '-0.5', 'spread': '3.1', 'groupId': 'OG006'}]}]}, {'title': 'Week 40 (n=6, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '4.2', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '4.8', 'groupId': 'OG002'}, {'value': '1.8', 'spread': '1.7', 'groupId': 'OG003'}, {'value': '1.8', 'spread': '1.5', 'groupId': 'OG004'}, {'value': '0.6', 'spread': '2.1', 'groupId': 'OG005'}, {'value': '-2.3', 'spread': '3.6', 'groupId': 'OG006'}]}]}, {'title': 'Week 52 (n=6, 6, 5, 6, 6, 5, 4)', 'categories': [{'measurements': [{'value': '-2.7', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '3.4', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '3.6', 'groupId': 'OG003'}, {'value': '1.8', 'spread': '2.6', 'groupId': 'OG004'}, {'value': '-0.8', 'spread': '4.2', 'groupId': 'OG005'}, {'value': '-1.5', 'spread': '1.7', 'groupId': 'OG006'}]}]}, {'title': 'Week 78 (n=4, 6, 5, 5, 6, 5, 4)', 'categories': [{'measurements': [{'value': '-4.8', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '4.5', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '2.2', 'groupId': 'OG002'}, {'value': '-0.8', 'spread': '1.9', 'groupId': 'OG003'}, {'value': '0.3', 'spread': '2.3', 'groupId': 'OG004'}, {'value': '-2.0', 'spread': '2.9', 'groupId': 'OG005'}, {'value': '0.3', 'spread': '2.6', 'groupId': 'OG006'}]}]}, {'title': 'Week 104 (n=4, 0, 1, 0, 0, 1, 0)', 'categories': [{'measurements': [{'value': '-4.3', 'spread': '7.4', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG001'}, {'value': '4.0', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG004'}, {'value': '-6.0', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only one participant was evaluable.', 'groupId': 'OG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data were not analyzed as no participants were evaluable for the particular week.', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 24 months', 'description': 'The MMSE is a brief, structured examination of cognitive function. It has a total score of 30 points (0-30), and any score equal to or lower than 26 points indicates cognitive impairment.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ACC-001 3 Micrograms +QS-21', 'description': 'A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'FG001', 'title': 'ACC-001 10 Micrograms', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12'}, {'id': 'FG002', 'title': 'ACC-001 10 Micrograms + QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day\n\n1, month 3, 6, 9 and 12'}, {'id': 'FG003', 'title': 'ACC-001 30 Micrograms', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'FG004', 'title': 'ACC-001 30 Micrograms +QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'FG005', 'title': 'QS-21', 'description': 'A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'FG006', 'title': 'Phosphate Buffered Saline (PBS)', 'description': 'A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Caregiver request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Investigator request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Subject request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Group home admission', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Caregiver could not attend the subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '40', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'ACC-001 3 Micrograms +QS-21', 'description': 'A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'BG001', 'title': 'ACC-001 10 Micrograms', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) at Day1, month 3, 6, 9 and 12'}, {'id': 'BG002', 'title': 'ACC-001 10 Micrograms + QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day\n\n1, month 3, 6, 9 and 12'}, {'id': 'BG003', 'title': 'ACC-001 30 Micrograms', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'BG004', 'title': 'ACC-001 30 Micrograms +QS-21', 'description': 'A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12'}, {'id': 'BG005', 'title': 'QS-21', 'description': 'A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12'}, {'id': 'BG006', 'title': 'Phosphate Buffered Saline (PBS)', 'description': 'A cohort of participants who received phosphate buffered saline (PBS) at Day 1, month 3, 6, 9 and 12'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.33', 'spread': '9.35', 'groupId': 'BG000'}, {'value': '69.50', 'spread': '6.92', 'groupId': 'BG001'}, {'value': '73.00', 'spread': '7.67', 'groupId': 'BG002'}, {'value': '70.17', 'spread': '3.13', 'groupId': 'BG003'}, {'value': '66.00', 'spread': '10.79', 'groupId': 'BG004'}, {'value': '67.00', 'spread': '9.19', 'groupId': 'BG005'}, {'value': '69.50', 'spread': '4.80', 'groupId': 'BG006'}, {'value': '69.50', 'spread': '7.68', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '23', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '17', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-30', 'studyFirstSubmitDate': '2008-09-11', 'resultsFirstSubmitDate': '2014-05-09', 'studyFirstSubmitQcDate': '2008-09-12', 'lastUpdatePostDateStruct': {'date': '2016-01-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-30', 'studyFirstPostDateStruct': {'date': '2008-09-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 36, 52, 78 and 104.", 'timeFrame': 'Baseline up to 24 months', 'description': 'The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility. For this stuy, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11. Total score ranges from 0 to 70 points, with higher scores indicating a greater degree of impairment.'}, {'measure': 'The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 36, 52, 78 and 104.', 'timeFrame': 'Baseline up to 24 months', 'description': 'The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores represent less disability in ADL while lower scores indicate more dysfunction.'}, {'measure': 'The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 36, 52, 78 and 104.', 'timeFrame': 'Baseline up to 24 months', 'description': "The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function. The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMSVerbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test. The NTB z-score is used for analysis. The z-score for each component is calculated through the following formula: z = (y\\_visit - y\\_base)/SD\\_base, where y\\_visit is a value at a particular time point and y\\_base is the average test score, and SD\\_base is the SD based on all participants' observed baseline scores in the study."}, {'measure': 'The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 36, 40, 52, 78 and 104.', 'timeFrame': 'Baseline up to 24 months', 'description': 'The MMSE is a brief, structured examination of cognitive function. It has a total score of 30 points (0-30), and any score equal to or lower than 26 points indicates cognitive impairment.'}], 'primaryOutcomes': [{'measure': 'Incidence of Treatment-emergent Adverse Events (AEs) by Severity', 'timeFrame': 'Baseline up to 24 months', 'description': "Number of participants who experienced mild, moderate, or severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)"}, {'measure': 'Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data', 'timeFrame': 'Baseline up to 24 months', 'description': 'Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by investigator.'}, {'measure': 'Number of Participants With Abnormalities in Neurological Examination', 'timeFrame': 'Baseline up to 24 months', 'description': 'Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerves (including pupil equality and reactivity), Visual field, Sensory, Motor, Coordination, Gait, Primitive reflexes, Tendon reflexes and Romberg.'}], 'secondaryOutcomes': [{'measure': 'Anti-a-beta IgG Titer at Specified Visits', 'timeFrame': 'Baseline up to 24 months', 'description': 'Geometric mean of anti-a-beta IgG titer from pre-study through Week 104'}, {'measure': 'Anti-a-beta IgM Titer at Specified Visits', 'timeFrame': 'Baseline up to 24 months', 'description': 'Geometric mean of anti-a-beta IgM titer from pre-study through Week 104'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Phase IIa', 'multiple ascending dose study of ACC-001'], 'conditions': ['Alzheimer Disease']}, 'referencesModule': {'references': [{'pmid': '25731629', 'type': 'DERIVED', 'citation': "Arai H, Suzuki H, Yoshiyama T. Vanutide cridificar and the QS-21 adjuvant in Japanese subjects with mild to moderate Alzheimer's disease: results from two phase 2 studies. Curr Alzheimer Res. 2015;12(3):242-54. doi: 10.2174/1567205012666150302154121."}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3134K1-2202&StudyName=Study%20Evaluating%20ACC-001%20in%20Japanese%20Patients%20With%20Mild%20To%20Moderate%20Alzheimer%27s%20Disease', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The study is to evaluate the safety, tolerability and whether there is an immune system response to multiple doses of ACC-001 with or without the use of a substance that may increase the response to the drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of mild to moderate Alzheimer's Disease\n* Mini Mental Status Exam (MMSE) of 16-26\n\nExclusion Criteria:\n\n* Significant Neurological Disease\n* Major Psychiatric Disorder\n* Clinically significant systemic illness"}, 'identificationModule': {'nctId': 'NCT00752232', 'briefTitle': "Study Evaluating ACC-001 in Japanese Patients With Mild To Moderate Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': "A Phaseiia, Multicenter, Randomized, Third-party Unblinded, Adjuvant And Placebo-controlled, Multiple Ascending Dose, Safety, Tolerability And Immunogenicity Trial Of Acc-001 And Qs-21 Adjuvant In Japanese Subjects With Mild To Moderate Alzheimer's Disease.", 'orgStudyIdInfo': {'id': '3134K1-2202'}, 'secondaryIdInfos': [{'id': 'B2571006', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACC-001+QS-21', 'description': 'Active vaccine + adjuvant, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12', 'interventionNames': ['Biological: ACC-001', 'Other: QS-21']}, {'type': 'EXPERIMENTAL', 'label': 'ACC-001', 'description': 'Active vaccine, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12', 'interventionNames': ['Biological: ACC-001']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'QS-21', 'description': 'Adjuvant, IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12', 'interventionNames': ['Other: QS-21']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PBS', 'description': 'Placebo, IM injection, Day 1, month 3, 6, 9, 12', 'interventionNames': ['Other: PBS']}], 'interventions': [{'name': 'ACC-001', 'type': 'BIOLOGICAL', 'description': 'IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12', 'armGroupLabels': ['ACC-001+QS-21']}, {'name': 'QS-21', 'type': 'OTHER', 'description': 'IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12', 'armGroupLabels': ['ACC-001+QS-21']}, {'name': 'ACC-001', 'type': 'BIOLOGICAL', 'description': 'IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12', 'armGroupLabels': ['ACC-001']}, {'name': 'QS-21', 'type': 'OTHER', 'description': 'IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12', 'armGroupLabels': ['QS-21']}, {'name': 'PBS', 'type': 'OTHER', 'description': 'IM injection, Day 1, month 3, 6, 9, 12', 'armGroupLabels': ['PBS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '392-8510', 'city': 'Suwa', 'state': 'Nagano', 'country': 'Japan', 'facility': 'Suwa Red Cross Hospital', 'geoPoint': {'lat': 36.03799, 'lon': 138.11308}}, {'zip': '530-8480', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Tazuke Kofukai Medical Research Institute Kitano Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '569-8686', 'city': 'Takatsuki', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka Medical College Hospital', 'geoPoint': {'lat': 34.84833, 'lon': 135.61678}}, {'zip': '451-8511', 'city': 'Aichi', 'country': 'Japan', 'facility': 'Meitetsu Hospital', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'zip': '309-1793', 'city': 'Ibaraki', 'country': 'Japan', 'facility': 'Ibaraki Prefectural Central Hospital', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'zip': '243-8551', 'city': 'Kanagawa', 'country': 'Japan', 'facility': 'Shonan Atsugi Hospital', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': '252-0380', 'city': 'Kanagawa', 'country': 'Japan', 'facility': 'Kitasato University East Hospital', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': '113-8431', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Juntendo University Hospital', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '136-0075', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Juntendo Tokyo Koto Geriatric Medical Center', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}, {'zip': '158-8531', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Kanto Ctrl Hp of the Mutual Aid Asso of Public school Teache', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'JANSSEN Alzheimer Immunotherapy Research & Development, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}