Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-30 @ 12:34 PM
Study NCT ID:
NCT00479557
Status:
COMPLETED
Last Update Posted:
2016-01-01
First Post:
2007-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Evaluating Safety, Tolerability, And Immunogenicity Of ACC-001 In Subjects 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': {'timeFrame': 'Approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose.', '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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'ACC 3 µg+QS-21', 'description': 'Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.', 'otherNumAtRisk': 36, 'otherNumAffected': 34, 'seriousNumAtRisk': 36, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'ACC 10 µg+QS-21', 'description': 'Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.', 'otherNumAtRisk': 60, 'otherNumAffected': 48, 'seriousNumAtRisk': 60, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'ACC 30 µg+QS-21', 'description': 'Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.', 'otherNumAtRisk': 40, 'otherNumAffected': 35, 'seriousNumAtRisk': 40, 'seriousNumAffected': 7}, {'id': 'EG003', 'title': 'ACC 10 µg', 'description': 'Participants received 10 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.', 'otherNumAtRisk': 35, 'otherNumAffected': 28, 'seriousNumAtRisk': 35, 'seriousNumAffected': 5}, {'id': 'EG004', 'title': 'ACC 30 µg', 'description': 'Participants received 30 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.', 'otherNumAtRisk': 12, 'otherNumAffected': 10, 'seriousNumAtRisk': 12, 'seriousNumAffected': 5}, {'id': 'EG005', 'title': 'QS-21 Alone', 'description': 'Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.', 'otherNumAtRisk': 44, 'otherNumAffected': 40, 'seriousNumAtRisk': 44, 'seriousNumAffected': 5}, {'id': 'EG006', 'title': 'Phosphate Buffered Saline', 'description': 'Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.', 'otherNumAtRisk': 17, 'otherNumAffected': 17, 'seriousNumAtRisk': 17, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Injection site warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Injection site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 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'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Stress urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Skin erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'ACC 3 µg+QS-21', 'description': 'Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'OG001', 'title': 'ACC 10 µg+QS-21', 'description': 'Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'OG002', 'title': 'ACC 30 µg+QS-21', 'description': 'Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'OG003', 'title': 'ACC 10 µg', 'description': 'Participants received 10 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'OG004', 'title': 'ACC 30 µg', 'description': 'Participants received 30 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'OG005', 'title': 'QS-21 Alone', 'description': 'Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'OG006', 'title': 'Phosphate Buffered Saline', 'description': 'Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}], 'classes': [{'title': 'Percentage of participants with AEs', 'categories': [{'measurements': [{'value': '97.2', 'groupId': 'OG000'}, {'value': '93.3', 'groupId': 'OG001'}, {'value': '90.0', 'groupId': 'OG002'}, {'value': '91.4', 'groupId': 'OG003'}, {'value': '83.3', 'groupId': 'OG004'}, {'value': '90.9', 'groupId': 'OG005'}, {'value': '100', 'groupId': 'OG006'}]}]}, {'title': 'Percentage of participants with SAEs', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '18.3', 'groupId': 'OG001'}, {'value': '17.5', 'groupId': 'OG002'}, {'value': '14.3', 'groupId': 'OG003'}, {'value': '41.7', 'groupId': 'OG004'}, {'value': '11.4', 'groupId': 'OG005'}, {'value': '17.6', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose.', 'description': "An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor's clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all randomized participants with documented use of at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'ACC 3 µg+QS-21', 'description': 'Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'OG001', 'title': 'ACC 10 µg+QS-21', 'description': 'Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'OG002', 'title': 'ACC 30 µg+QS-21', 'description': 'Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'OG003', 'title': 'ACC 10 µg', 'description': 'Participants received 10 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'OG004', 'title': 'ACC 30 µg', 'description': 'Participants received 30 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'OG005', 'title': 'QS-21 Alone', 'description': 'Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'OG006', 'title': 'Phosphate Buffered Saline', 'description': 'Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}], 'classes': [{'title': 'Baseline (N: 36, 59, 40, 35, 12, 44, 17)', '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': '53.1', 'groupId': 'OG005', 'lowerLimit': '47.1', 'upperLimit': '59.8'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 2 (N: 35, 60, 39, 35, 12, 43, 16)', 'categories': [{'measurements': [{'value': '56.6', 'groupId': 'OG000', 'lowerLimit': '49.1', 'upperLimit': '65.3'}, {'value': '69.0', 'groupId': 'OG001', 'lowerLimit': '57.4', 'upperLimit': '83.0'}, {'value': '86.5', 'groupId': 'OG002', 'lowerLimit': '65.7', 'upperLimit': '113.9'}, {'value': '51.7', 'groupId': 'OG003', 'lowerLimit': '48.3', 'upperLimit': '55.2'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '52.5', 'groupId': 'OG005', 'lowerLimit': '47.5', 'upperLimit': '58.1'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 4 (N: 35, 57, 38, 31, 12, 43, 16)', 'categories': [{'measurements': [{'value': '53.2', 'groupId': 'OG000', 'lowerLimit': '48.5', 'upperLimit': '58.4'}, {'value': '77.1', 'groupId': 'OG001', 'lowerLimit': '61.9', 'upperLimit': '96.0'}, {'value': '82.8', 'groupId': 'OG002', 'lowerLimit': '63.0', 'upperLimit': '108.8'}, {'value': '50.0', 'groupId': 'OG003', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '50.0', 'groupId': 'OG004', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '51.3', 'groupId': 'OG005', 'lowerLimit': '48.7', 'upperLimit': '53.9'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 6 (N: 36, 58, 37, 33, 12, 41, 16)', 'categories': [{'measurements': [{'value': '634.8', 'groupId': 'OG000', 'lowerLimit': '322.7', 'upperLimit': '1248.5'}, {'value': '1089.4', 'groupId': 'OG001', 'lowerLimit': '646.0', 'upperLimit': '1837.2'}, {'value': '1343.5', 'groupId': 'OG002', 'lowerLimit': '716.0', 'upperLimit': '2521.1'}, {'value': '73.4', 'groupId': 'OG003', 'lowerLimit': '50.6', 'upperLimit': '106.4'}, {'value': '103.7', 'groupId': 'OG004', 'lowerLimit': '38.2', 'upperLimit': '281.4'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 8 (N: 33, 57, 39, 33, 12, 41, 17)', 'categories': [{'measurements': [{'value': '497.4', 'groupId': 'OG000', 'lowerLimit': '253.5', 'upperLimit': '976.1'}, {'value': '885.2', 'groupId': 'OG001', 'lowerLimit': '530.0', 'upperLimit': '1478.7'}, {'value': '1098.2', 'groupId': 'OG002', 'lowerLimit': '626.9', 'upperLimit': '1924.0'}, {'value': '66.3', 'groupId': 'OG003', 'lowerLimit': '48.2', 'upperLimit': '91.1'}, {'value': '99.8', 'groupId': 'OG004', 'lowerLimit': '38.8', 'upperLimit': '256.6'}, {'value': '52.4', 'groupId': 'OG005', 'lowerLimit': '47.6', 'upperLimit': '57.7'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 10 (N: 34, 59, 40, 33, 12, 43, 17)', 'categories': [{'measurements': [{'value': '292.3', 'groupId': 'OG000', 'lowerLimit': '156.5', 'upperLimit': '546.0'}, {'value': '762.8', 'groupId': 'OG001', 'lowerLimit': '468.5', 'upperLimit': '1242.2'}, {'value': '878.5', 'groupId': 'OG002', 'lowerLimit': '531.3', 'upperLimit': '1452.6'}, {'value': '77.0', 'groupId': 'OG003', 'lowerLimit': '48.0', 'upperLimit': '123.3'}, {'value': '94.9', 'groupId': 'OG004', 'lowerLimit': '39.8', 'upperLimit': '226.5'}, {'value': '53.0', 'groupId': 'OG005', 'lowerLimit': '47.1', 'upperLimit': '59.7'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 14 (N: 33, 52, 39, 31, 11, 33, 14)', 'categories': [{'measurements': [{'value': '907.5', 'groupId': 'OG000', 'lowerLimit': '474.6', 'upperLimit': '1735.6'}, {'value': '2892.3', 'groupId': 'OG001', 'lowerLimit': '1705.9', 'upperLimit': '4903.8'}, {'value': '3136.8', 'groupId': 'OG002', 'lowerLimit': '1877.6', 'upperLimit': '5240.7'}, {'value': '89.6', 'groupId': 'OG003', 'lowerLimit': '50.8', 'upperLimit': '158.3'}, {'value': '199.4', 'groupId': 'OG004', 'lowerLimit': '73.7', 'upperLimit': '539.8'}, {'value': '50.0', 'groupId': 'OG005', 'lowerLimit': '50.0', 'upperLimit': '50.0'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 16 (N: 33, 59, 38, 34, 12, 41, 16)', 'categories': [{'measurements': [{'value': '996.1', 'groupId': 'OG000', 'lowerLimit': '487.1', 'upperLimit': '2037.1'}, {'value': '3273.2', 'groupId': 'OG001', 'lowerLimit': '2083.9', 'upperLimit': '5141.4'}, {'value': '3324.7', 'groupId': 'OG002', 'lowerLimit': '1959.4', 'upperLimit': '5641.3'}, {'value': '91.7', 'groupId': 'OG003', 'lowerLimit': '55.2', 'upperLimit': '152.1'}, {'value': '133.9', 'groupId': 'OG004', 'lowerLimit': '56.1', 'upperLimit': '319.9'}, {'value': '52.6', 'groupId': 'OG005', 'lowerLimit': '47.5', 'upperLimit': '58.1'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 24 (N: 34, 58, 37, 33, 10, 40, 16)', 'categories': [{'measurements': [{'value': '547.8', 'groupId': 'OG000', 'lowerLimit': '278.8', 'upperLimit': '1076.3'}, {'value': '1827.6', 'groupId': 'OG001', 'lowerLimit': '1145.3', 'upperLimit': '2916.1'}, {'value': '1231.3', 'groupId': 'OG002', 'lowerLimit': '712.2', 'upperLimit': '2128.6'}, {'value': '76.1', 'groupId': 'OG003', 'lowerLimit': '52.1', 'upperLimit': '111.1'}, {'value': '139.1', 'groupId': 'OG004', 'lowerLimit': '52.1', 'upperLimit': '371.3'}, {'value': '52.3', 'groupId': 'OG005', 'lowerLimit': '47.4', 'upperLimit': '57.4'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 28 (N: 31, 51, 33, 29, 8, 36, 16)', 'categories': [{'measurements': [{'value': '2011.2', 'groupId': 'OG000', 'lowerLimit': '986.9', 'upperLimit': '4098.8'}, {'value': '4299.6', 'groupId': 'OG001', 'lowerLimit': '2843.8', 'upperLimit': '6500.8'}, {'value': '5407.7', 'groupId': 'OG002', 'lowerLimit': '3676.0', 'upperLimit': '7955.3'}, {'value': '108.9', 'groupId': 'OG003', 'lowerLimit': '61.9', 'upperLimit': '191.8'}, {'value': '334.1', 'groupId': 'OG004', 'lowerLimit': '77.1', 'upperLimit': '1448.3'}, {'value': '52.4', 'groupId': 'OG005', 'lowerLimit': '47.6', 'upperLimit': '57.6'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 30 (N: 33, 56, 36, 32, 10, 38, 16)', 'categories': [{'measurements': [{'value': '2028.9', 'groupId': 'OG000', 'lowerLimit': '1035.8', 'upperLimit': '3973.8'}, {'value': '4316.8', 'groupId': 'OG001', 'lowerLimit': '2900.2', 'upperLimit': '6425.2'}, {'value': '4713.0', 'groupId': 'OG002', 'lowerLimit': '3076.0', 'upperLimit': '7221.2'}, {'value': '110.4', 'groupId': 'OG003', 'lowerLimit': '64.1', 'upperLimit': '190.0'}, {'value': '234.5', 'groupId': 'OG004', 'lowerLimit': '65.3', 'upperLimit': '842.5'}, {'value': '51.8', 'groupId': 'OG005', 'lowerLimit': '48.2', 'upperLimit': '55.7'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 40 (N: 32, 54, 33, 33, 9, 37, 15)', 'categories': [{'measurements': [{'value': '1167.3', 'groupId': 'OG000', 'lowerLimit': '609.1', 'upperLimit': '2237.1'}, {'value': '2147.2', 'groupId': 'OG001', 'lowerLimit': '1407.6', 'upperLimit': '3275.3'}, {'value': '2292.9', 'groupId': 'OG002', 'lowerLimit': '1436.6', 'upperLimit': '3659.8'}, {'value': '97.2', 'groupId': 'OG003', 'lowerLimit': '62.4', 'upperLimit': '151.3'}, {'value': '211.0', 'groupId': 'OG004', 'lowerLimit': '53.6', 'upperLimit': '830.7'}, {'value': '52.1', 'groupId': 'OG005', 'lowerLimit': '47.9', 'upperLimit': '56.7'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 50 (N: 29, 53, 33, 33, 9, 36, 16)', 'categories': [{'measurements': [{'value': '937.3', 'groupId': 'OG000', 'lowerLimit': '482.0', 'upperLimit': '1822.6'}, {'value': '1364.4', 'groupId': 'OG001', 'lowerLimit': '911.9', 'upperLimit': '2041.4'}, {'value': '1262.3', 'groupId': 'OG002', 'lowerLimit': '828.5', 'upperLimit': '1923.2'}, {'value': '80.7', 'groupId': 'OG003', 'lowerLimit': '54.8', 'upperLimit': '118.9'}, {'value': '168.4', 'groupId': 'OG004', 'lowerLimit': '52.4', 'upperLimit': '541.3'}, {'value': '52.8', 'groupId': 'OG005', 'lowerLimit': '47.3', 'upperLimit': '58.8'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 54 (N: 27, 51, 30, 29, 9, 29, 14)', 'categories': [{'measurements': [{'value': '2031.6', 'groupId': 'OG000', 'lowerLimit': '1024.2', 'upperLimit': '4029.7'}, {'value': '5744.6', 'groupId': 'OG001', 'lowerLimit': '3609.1', 'upperLimit': '9143.7'}, {'value': '6677.3', 'groupId': 'OG002', 'lowerLimit': '3678.7', 'upperLimit': '12120.1'}, {'value': '160.6', 'groupId': 'OG003', 'lowerLimit': '69.7', 'upperLimit': '370.2'}, {'value': '491.6', 'groupId': 'OG004', 'lowerLimit': '85.9', 'upperLimit': '2812.2'}, {'value': '55.0', 'groupId': 'OG005', 'lowerLimit': '45.2', 'upperLimit': '66.9'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 56 (N: 31, 52, 34, 32, 9, 34, 15)', 'categories': [{'measurements': [{'value': '2635.7', 'groupId': 'OG000', 'lowerLimit': '1355.5', 'upperLimit': '5125.2'}, {'value': '5906.1', 'groupId': 'OG001', 'lowerLimit': '4058.8', 'upperLimit': '8594.2'}, {'value': '7642.5', 'groupId': 'OG002', 'lowerLimit': '5057.9', 'upperLimit': '11547.9'}, {'value': '159.2', 'groupId': 'OG003', 'lowerLimit': '74.2', 'upperLimit': '341.8'}, {'value': '463.7', 'groupId': 'OG004', 'lowerLimit': '81.1', 'upperLimit': '2650.5'}, {'value': '53.4', 'groupId': 'OG005', 'lowerLimit': '46.7', 'upperLimit': '60.9'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 66 (N: 31, 54,34, 31, 9, 33, 15)', 'categories': [{'measurements': [{'value': '1372.0', 'groupId': 'OG000', 'lowerLimit': '717.1', 'upperLimit': '2625.1'}, {'value': '2867.4', 'groupId': 'OG001', 'lowerLimit': '1835.9', 'upperLimit': '4478.5'}, {'value': '2882.2', 'groupId': 'OG002', 'lowerLimit': '1793.1', 'upperLimit': '4632.8'}, {'value': '166.3', 'groupId': 'OG003', 'lowerLimit': '78.8', 'upperLimit': '350.9'}, {'value': '280.0', 'groupId': 'OG004', 'lowerLimit': '56.3', 'upperLimit': '1393.9'}, {'value': '63.5', 'groupId': 'OG005', 'lowerLimit': '43.7', 'upperLimit': '92.3'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 78 (N: 31, 52, 32, 32, 8, 32, 14)', 'categories': [{'measurements': [{'value': '1108.4', 'groupId': 'OG000', 'lowerLimit': '585.1', 'upperLimit': '2099.4'}, {'value': '1867.5', 'groupId': 'OG001', 'lowerLimit': '1197.4', 'upperLimit': '2912.5'}, {'value': '1338.1', 'groupId': 'OG002', 'lowerLimit': '827.3', 'upperLimit': '2164.4'}, {'value': '142.7', 'groupId': 'OG003', 'lowerLimit': '71.5', 'upperLimit': '285.1'}, {'value': '256.1', 'groupId': 'OG004', 'lowerLimit': '58.2', 'upperLimit': '1128.2'}, {'value': '53.6', 'groupId': 'OG005', 'lowerLimit': '46.5', 'upperLimit': '61.6'}, {'value': '50.0', 'groupId': 'OG006', 'lowerLimit': '50.0', 'upperLimit': '50.0'}]}]}, {'title': 'Week 91 (N: 15, 9, 3, 8, 2, 6, 2)', 'categories': [{'measurements': [{'value': '1824.6', 'groupId': 'OG000', 'lowerLimit': '1063.2', 'upperLimit': '3131.2'}, {'value': '2497.0', 'groupId': 'OG001', 'lowerLimit': '644.8', 'upperLimit': '9670.1'}, {'value': '543.0', 'groupId': 'OG002', 'lowerLimit': '33.6', 'upperLimit': '8767.8'}, {'value': '76.8', 'groupId': 'OG003', 'lowerLimit': '27.8', 'upperLimit': '211.9'}, {'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 104 (N: 15, 9, 4, 7, 1, 6, 2)', 'categories': [{'measurements': [{'value': '1326.1', 'groupId': 'OG000', 'lowerLimit': '785.0', 'upperLimit': '2240.2'}, {'value': '2212.7', 'groupId': 'OG001', 'lowerLimit': '406.4', 'upperLimit': '12048.4'}, {'value': '243.3', 'groupId': 'OG002', 'lowerLimit': '28.8', 'upperLimit': '2052.4'}, {'value': '98.9', 'groupId': 'OG003', 'lowerLimit': '30.7', 'upperLimit': '318.3'}, {'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'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104', 'description': 'The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.', 'unitOfMeasure': 'U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The immunogenicity population included all randomized participants with documented injection of at least one dose of study drug and at least one immunogenicity data point collected.'}, {'type': 'SECONDARY', 'title': 'GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '44', 'groupId': 'OG005'}, {'value': '17', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'ACC 3 µg+QS-21', 'description': 'Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'OG001', 'title': 'ACC 10 µg+QS-21', 'description': 'Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'OG002', 'title': 'ACC 30 µg+QS-21', 'description': 'Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'OG003', 'title': 'ACC 10 µg', 'description': 'Participants received 10 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'OG004', 'title': 'ACC 30 µg', 'description': 'Participants received 30 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'OG005', 'title': 'QS-21 Alone', 'description': 'Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'OG006', 'title': 'Phosphate Buffered Saline', 'description': 'Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}], 'classes': [{'title': 'Baseline (N: 36, 59, 40, 35, 12, 44, 17)', 'categories': [{'measurements': [{'value': '32.3', 'groupId': 'OG000', 'lowerLimit': '24.6', 'upperLimit': '42.4'}, {'value': '38.2', 'groupId': 'OG001', 'lowerLimit': '30.8', 'upperLimit': '47.2'}, {'value': '34.2', 'groupId': 'OG002', 'lowerLimit': '27.7', 'upperLimit': '42.2'}, {'value': '32.9', 'groupId': 'OG003', 'lowerLimit': '28.1', 'upperLimit': '38.5'}, {'value': '40.3', 'groupId': 'OG004', 'lowerLimit': '27.1', 'upperLimit': '59.9'}, {'value': '30.8', 'groupId': 'OG005', 'lowerLimit': '26.4', 'upperLimit': '36.0'}, {'value': '25.0', 'groupId': 'OG006', 'lowerLimit': '25.0', 'upperLimit': '25.0'}]}]}, {'title': 'Week 2 (N: 35, 60, 39, 35, 12,43, 16)', 'categories': [{'measurements': [{'value': '85.1', 'groupId': 'OG000', 'lowerLimit': '54.2', 'upperLimit': '133.8'}, {'value': '127.7', 'groupId': 'OG001', 'lowerLimit': '79.5', 'upperLimit': '205.0'}, {'value': '254.5', 'groupId': 'OG002', 'lowerLimit': '133.6', 'upperLimit': '484.9'}, {'value': '46.5', 'groupId': 'OG003', 'lowerLimit': '32.4', 'upperLimit': '66.7'}, {'value': '76.9', 'groupId': 'OG004', 'lowerLimit': '40.5', 'upperLimit': '146.2'}, {'value': '31.5', 'groupId': 'OG005', 'lowerLimit': '26.6', 'upperLimit': '37.3'}, {'value': '26.5', 'groupId': 'OG006', 'lowerLimit': '23.4', 'upperLimit': '29.9'}]}]}, {'title': 'Week 4 (N: 35, 57, 38, 31, 12, 43, 16)', 'categories': [{'measurements': [{'value': '82.3', 'groupId': 'OG000', 'lowerLimit': '52.8', 'upperLimit': '128.4'}, {'value': '123.4', 'groupId': 'OG001', 'lowerLimit': '75.9', 'upperLimit': '200.7'}, {'value': '276.6', 'groupId': 'OG002', 'lowerLimit': '143.3', 'upperLimit': '533.6'}, {'value': '48.2', 'groupId': 'OG003', 'lowerLimit': '33.2', 'upperLimit': '70.2'}, {'value': '92.0', 'groupId': 'OG004', 'lowerLimit': '46.7', 'upperLimit': '181.1'}, {'value': '33.2', 'groupId': 'OG005', 'lowerLimit': '28.0', 'upperLimit': '39.3'}, {'value': '27.3', 'groupId': 'OG006', 'lowerLimit': '24.0', 'upperLimit': '30.9'}]}]}, {'title': 'Week 6 (M: 36, 58, 37, 33, 12, 41, 16)', 'categories': [{'measurements': [{'value': '626.5', 'groupId': 'OG000', 'lowerLimit': '340.5', 'upperLimit': '1152.8'}, {'value': '1283.8', 'groupId': 'OG001', 'lowerLimit': '742.6', 'upperLimit': '2219.4'}, {'value': '1736.6', 'groupId': 'OG002', 'lowerLimit': '906.4', 'upperLimit': '3327.1'}, {'value': '72.3', 'groupId': 'OG003', 'lowerLimit': '40.8', 'upperLimit': '128.2'}, {'value': '144.1', 'groupId': 'OG004', 'lowerLimit': '55.9', 'upperLimit': '371.6'}, {'value': '31.1', 'groupId': 'OG005', 'lowerLimit': '26.6', 'upperLimit': '36.3'}, {'value': '25.0', 'groupId': 'OG006', 'lowerLimit': '25.0', 'upperLimit': '25.0'}]}]}, {'title': 'Week 8 (N: 33, 57, 39, 33, 12, 41, 17)', 'categories': [{'measurements': [{'value': '758.9', 'groupId': 'OG000', 'lowerLimit': '388.6', 'upperLimit': '1482.4'}, {'value': '1903.8', 'groupId': 'OG001', 'lowerLimit': '1097.7', 'upperLimit': '3301.9'}, {'value': '2769.5', 'groupId': 'OG002', 'lowerLimit': '1407.2', 'upperLimit': '5450.9'}, {'value': '70.8', 'groupId': 'OG003', 'lowerLimit': '40.8', 'upperLimit': '123.0'}, {'value': '166.4', 'groupId': 'OG004', 'lowerLimit': '60.3', 'upperLimit': '459.3'}, {'value': '31.0', 'groupId': 'OG005', 'lowerLimit': '26.1', 'upperLimit': '36.8'}, {'value': '26.3', 'groupId': 'OG006', 'lowerLimit': '23.6', 'upperLimit': '29.4'}]}]}, {'title': 'Week 10 (N: 34, 59, 40, 33, 12, 43, 17)', 'categories': [{'measurements': [{'value': '595.2', 'groupId': 'OG000', 'lowerLimit': '310.0', 'upperLimit': '1143.0'}, {'value': '1697.7', 'groupId': 'OG001', 'lowerLimit': '980.8', 'upperLimit': '2938.6'}, {'value': '2598.1', 'groupId': 'OG002', 'lowerLimit': '1382.6', 'upperLimit': '4882.0'}, {'value': '69.9', 'groupId': 'OG003', 'lowerLimit': '38.3', 'upperLimit': '127.6'}, {'value': '157.1', 'groupId': 'OG004', 'lowerLimit': '56.1', 'upperLimit': '440.1'}, {'value': '36.6', 'groupId': 'OG005', 'lowerLimit': '28.0', 'upperLimit': '47.9'}, {'value': '27.3', 'groupId': 'OG006', 'lowerLimit': '24.0', 'upperLimit': '31.1'}]}]}, {'title': 'Week 14 (N: 33, 52, 39, 31, 11, 33, 14)', 'categories': [{'measurements': [{'value': '770.2', 'groupId': 'OG000', 'lowerLimit': '416.1', 'upperLimit': '1425.6'}, {'value': '2721.0', 'groupId': 'OG001', 'lowerLimit': '1608.3', 'upperLimit': '4603.4'}, {'value': '5271.3', 'groupId': 'OG002', 'lowerLimit': '2904.4', 'upperLimit': '9567.3'}, {'value': '80.8', 'groupId': 'OG003', 'lowerLimit': '40.2', 'upperLimit': '162.3'}, {'value': '290.7', 'groupId': 'OG004', 'lowerLimit': '71.8', 'upperLimit': '1177.7'}, {'value': '31.0', 'groupId': 'OG005', 'lowerLimit': '25.5', 'upperLimit': '37.8'}, {'value': '25.0', 'groupId': 'OG006', 'lowerLimit': '25.0', 'upperLimit': '25.0'}]}]}, {'title': 'Week 16 (N: 33, 59, 38, 34, 12, 41, 16)', 'categories': [{'measurements': [{'value': '727.3', 'groupId': 'OG000', 'lowerLimit': '395.0', 'upperLimit': '1339.0'}, {'value': '3098.3', 'groupId': 'OG001', 'lowerLimit': '1904.1', 'upperLimit': '5041.2'}, {'value': '5666.4', 'groupId': 'OG002', 'lowerLimit': '3264.6', 'upperLimit': '9835.3'}, {'value': '93.4', 'groupId': 'OG003', 'lowerLimit': '47.5', 'upperLimit': '183.4'}, {'value': '271.8', 'groupId': 'OG004', 'lowerLimit': '70.5', 'upperLimit': '1047.5'}, {'value': '34.5', 'groupId': 'OG005', 'lowerLimit': '27.6', 'upperLimit': '43.0'}, {'value': '25.0', 'groupId': 'OG006', 'lowerLimit': '25.0', 'upperLimit': '25.0'}]}]}, {'title': 'Week 24 (N: 34, 58, 37, 33, 10, 40, 16)', 'categories': [{'measurements': [{'value': '461.3', 'groupId': 'OG000', 'lowerLimit': '260.4', 'upperLimit': '817.2'}, {'value': '1862.5', 'groupId': 'OG001', 'lowerLimit': '1137.9', 'upperLimit': '3048.3'}, {'value': '2672.4', 'groupId': 'OG002', 'lowerLimit': '1553.6', 'upperLimit': '4597.0'}, {'value': '90.8', 'groupId': 'OG003', 'lowerLimit': '48.1', 'upperLimit': '171.3'}, {'value': '296.2', 'groupId': 'OG004', 'lowerLimit': '56.3', 'upperLimit': '1549.6'}, {'value': '30.9', 'groupId': 'OG005', 'lowerLimit': '26.1', 'upperLimit': '36.7'}, {'value': '26.6', 'groupId': 'OG006', 'lowerLimit': '23.3', 'upperLimit': '30.2'}]}]}, {'title': 'Week 28 (N: 31, 51, 33, 29, 8, 36, 16)', 'categories': [{'measurements': [{'value': '669.0', 'groupId': 'OG000', 'lowerLimit': '388.0', 'upperLimit': '1153.6'}, {'value': '1915.3', 'groupId': 'OG001', 'lowerLimit': '1256.2', 'upperLimit': '2920.0'}, {'value': '3593.2', 'groupId': 'OG002', 'lowerLimit': '2050.4', 'upperLimit': '6296.9'}, {'value': '105.5', 'groupId': 'OG003', 'lowerLimit': '50.2', 'upperLimit': '221.6'}, {'value': '590.9', 'groupId': 'OG004', 'lowerLimit': '63.4', 'upperLimit': '5511.6'}, {'value': '31.3', 'groupId': 'OG005', 'lowerLimit': '26.1', 'upperLimit': '37.5'}, {'value': '25.0', 'groupId': 'OG006', 'lowerLimit': '25.0', 'upperLimit': '25.0'}]}]}, {'title': 'Week 30 (N: 33, 56, 36, 32, 10, 38, 16)', 'categories': [{'measurements': [{'value': '717.3', 'groupId': 'OG000', 'lowerLimit': '432.6', 'upperLimit': '1189.5'}, {'value': '2259.4', 'groupId': 'OG001', 'lowerLimit': '1524.0', 'upperLimit': '3349.6'}, {'value': '4147.2', 'groupId': 'OG002', 'lowerLimit': '2423.1', 'upperLimit': '7098.1'}, {'value': '128.4', 'groupId': 'OG003', 'lowerLimit': '63.1', 'upperLimit': '261.1'}, {'value': '343.3', 'groupId': 'OG004', 'lowerLimit': '49.9', 'upperLimit': '2361.4'}, {'value': '37.8', 'groupId': 'OG005', 'lowerLimit': '27.7', 'upperLimit': '51.6'}, {'value': '25.0', 'groupId': 'OG006', 'lowerLimit': '25.0', 'upperLimit': '25.0'}]}]}, {'title': 'Week 40 (N: 32, 54, 33, 33, 9, 37, 15)', 'categories': [{'measurements': [{'value': '559.0', 'groupId': 'OG000', 'lowerLimit': '350.7', 'upperLimit': '891.0'}, {'value': '1351.6', 'groupId': 'OG001', 'lowerLimit': '885.3', 'upperLimit': '2063.3'}, {'value': '1855.9', 'groupId': 'OG002', 'lowerLimit': '1074.3', 'upperLimit': '3206.1'}, {'value': '103.9', 'groupId': 'OG003', 'lowerLimit': '54.2', 'upperLimit': '199.3'}, {'value': '311.9', 'groupId': 'OG004', 'lowerLimit': '39.1', 'upperLimit': '2491.7'}, {'value': '34.2', 'groupId': 'OG005', 'lowerLimit': '28.1', 'upperLimit': '41.6'}, {'value': '25.0', 'groupId': 'OG006', 'lowerLimit': '25.0', 'upperLimit': '25.0'}]}]}, {'title': 'Week 50 (N: 29, 53, 33, 33, 9, 36, 16)', 'categories': [{'measurements': [{'value': '351.3', 'groupId': 'OG000', 'lowerLimit': '210.2', 'upperLimit': '587.2'}, {'value': '1049.6', 'groupId': 'OG001', 'lowerLimit': '701.4', 'upperLimit': '1570.8'}, {'value': '1246.4', 'groupId': 'OG002', 'lowerLimit': '707.2', 'upperLimit': '2196.7'}, {'value': '84.7', 'groupId': 'OG003', 'lowerLimit': '45.6', 'upperLimit': '157.3'}, {'value': '294.6', 'groupId': 'OG004', 'lowerLimit': '41.2', 'upperLimit': '2104.6'}, {'value': '32.2', 'groupId': 'OG005', 'lowerLimit': '27.1', 'upperLimit': '38.3'}, {'value': '25.0', 'groupId': 'OG006', 'lowerLimit': '25.0', 'upperLimit': '25.0'}]}]}, {'title': 'Week 54 (N: 27, 51, 30, 29, 9, 29, 14)', 'categories': [{'measurements': [{'value': '477.7', 'groupId': 'OG000', 'lowerLimit': '305.2', 'upperLimit': '747.7'}, {'value': '1529.1', 'groupId': 'OG001', 'lowerLimit': '1045.4', 'upperLimit': '2236.7'}, {'value': '2479.5', 'groupId': 'OG002', 'lowerLimit': '1373.5', 'upperLimit': '4476.4'}, {'value': '121.1', 'groupId': 'OG003', 'lowerLimit': '52.1', 'upperLimit': '281.7'}, {'value': '436.9', 'groupId': 'OG004', 'lowerLimit': '52.1', 'upperLimit': '3662.2'}, {'value': '36.2', 'groupId': 'OG005', 'lowerLimit': '28.4', 'upperLimit': '46.3'}, {'value': '27.2', 'groupId': 'OG006', 'lowerLimit': '22.7', 'upperLimit': '32.5'}]}]}, {'title': 'Week 56 (N: 31, 52, 34, 32, 9, 34, 15)', 'categories': [{'measurements': [{'value': '598.7', 'groupId': 'OG000', 'lowerLimit': '375.1', 'upperLimit': '955.5'}, {'value': '1696.1', 'groupId': 'OG001', 'lowerLimit': '1173.6', 'upperLimit': '2451.3'}, {'value': '2681.8', 'groupId': 'OG002', 'lowerLimit': '1480.7', 'upperLimit': '4857.0'}, {'value': '109.8', 'groupId': 'OG003', 'lowerLimit': '49.4', 'upperLimit': '244.1'}, {'value': '438.5', 'groupId': 'OG004', 'lowerLimit': '51.5', 'upperLimit': '3734.3'}, {'value': '34.3', 'groupId': 'OG005', 'lowerLimit': '27.2', 'upperLimit': '43.2'}, {'value': '29.5', 'groupId': 'OG006', 'lowerLimit': '22.6', 'upperLimit': '38.6'}]}]}, {'title': 'Week 66 (N: 31, 54, 34, 31, 9, 33, 15)', 'categories': [{'measurements': [{'value': '457.6', 'groupId': 'OG000', 'lowerLimit': '282.2', 'upperLimit': '742.1'}, {'value': '1422.0', 'groupId': 'OG001', 'lowerLimit': '980.7', 'upperLimit': '2061.9'}, {'value': '1637.2', 'groupId': 'OG002', 'lowerLimit': '961.9', 'upperLimit': '2786.6'}, {'value': '114.3', 'groupId': 'OG003', 'lowerLimit': '51.6', 'upperLimit': '253.1'}, {'value': '342.1', 'groupId': 'OG004', 'lowerLimit': '41.2', 'upperLimit': '2839.9'}, {'value': '36.1', 'groupId': 'OG005', 'lowerLimit': '26.5', 'upperLimit': '49.1'}, {'value': '27.8', 'groupId': 'OG006', 'lowerLimit': '23.8', 'upperLimit': '32.6'}]}]}, {'title': 'Week 78 (N: 31, 52, 32, 32, 8, 32, 14)', 'categories': [{'measurements': [{'value': '368.2', 'groupId': 'OG000', 'lowerLimit': '238.4', 'upperLimit': '568.7'}, {'value': '1204.4', 'groupId': 'OG001', 'lowerLimit': '815.6', 'upperLimit': '1778.6'}, {'value': '1217.7', 'groupId': 'OG002', 'lowerLimit': '706.1', 'upperLimit': '2100.1'}, {'value': '107.5', 'groupId': 'OG003', 'lowerLimit': '52.2', 'upperLimit': '221.4'}, {'value': '346.0', 'groupId': 'OG004', 'lowerLimit': '31.2', 'upperLimit': '3832.0'}, {'value': '34.6', 'groupId': 'OG005', 'lowerLimit': '27.9', 'upperLimit': '43.0'}, {'value': '28.9', 'groupId': 'OG006', 'lowerLimit': '23.4', 'upperLimit': '35.8'}]}]}, {'title': 'Week 91 (N: 15, 9, 3, 8, 2, 6, 2)', 'categories': [{'measurements': [{'value': '391.2', 'groupId': 'OG000', 'lowerLimit': '205.6', 'upperLimit': '744.2'}, {'value': '1203.4', 'groupId': 'OG001', 'lowerLimit': '399.9', 'upperLimit': '3621.9'}, {'value': '679.2', 'groupId': 'OG002', 'lowerLimit': '28.5', 'upperLimit': '16208.4'}, {'value': '98.9', 'groupId': 'OG003', 'lowerLimit': '18.4', 'upperLimit': '530.4'}, {'value': '25.0', 'groupId': 'OG004', 'lowerLimit': '25.0', 'upperLimit': '25.0'}, {'value': '28.3', 'groupId': 'OG005', 'lowerLimit': '20.5', 'upperLimit': '39.1'}, {'value': '25.0', 'groupId': 'OG006', 'lowerLimit': '25.0', 'upperLimit': '25.0'}]}]}, {'title': 'Week 104 (N: 15, 9, 4, 7, 1, 6, 2)', 'categories': [{'measurements': [{'value': '299.1', 'groupId': 'OG000', 'lowerLimit': '144.2', 'upperLimit': '620.8'}, {'value': '1561.8', 'groupId': 'OG001', 'lowerLimit': '438.0', 'upperLimit': '5569.0'}, {'value': '620.3', 'groupId': 'OG002', 'lowerLimit': '78.8', 'upperLimit': '4882.2'}, {'value': '176.7', 'groupId': 'OG003', 'lowerLimit': '26.1', 'upperLimit': '1197.0'}, {'value': '25.0', 'groupId': 'OG004', 'lowerLimit': '25.0', 'upperLimit': '25.0'}, {'value': '25.0', 'groupId': 'OG005', 'lowerLimit': '25.0', 'upperLimit': '25.0'}, {'value': '25.0', 'groupId': 'OG006', 'lowerLimit': '25.0', 'upperLimit': '25.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104', 'description': 'The LLOQ was 50 U/mL and when the assay result was below LLOQ (50 U/mL), 25 U/mL was imputed for IgM.', 'unitOfMeasure': 'U/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The immunogenicity population included all randomized participants with documented injection of at least one dose of study drug and at least one immunogenicity data point collected.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable)', 'denoms': [{'units': 'Participants', 'counts': [{'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'}]}], 'groups': [{'id': 'OG000', 'title': 'ACC 3 μg+QS-21', 'description': 'Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'OG001', 'title': 'ACC 10 μg+QS-21', 'description': 'Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'OG002', 'title': 'ACC 30 μg+QS-21', 'description': 'Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'OG003', 'title': 'ACC 10 μg', 'description': 'Participants received 10 μg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'OG004', 'title': 'ACC 30 μg', 'description': 'Participants received 30 μg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'OG005', 'title': 'QS-21 Alone', 'description': 'Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'OG006', 'title': 'Phosphate Buffered Saline', 'description': 'Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}], 'timeFrame': 'Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104', 'description': 'IgG subtypes were not assessed', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ACC 3 µg+QS-21', 'description': 'Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'FG001', 'title': 'ACC 10 µg+QS-21', 'description': 'Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'FG002', 'title': 'ACC 30 µg+QS-21', 'description': 'Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'FG003', 'title': 'ACC 10 µg', 'description': 'Participants received 10 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'FG004', 'title': 'ACC 30 µg', 'description': 'Participants received 30 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'FG005', 'title': 'QS-21 Alone', 'description': 'Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'FG006', 'title': 'Phosphate Buffered Saline', 'description': 'Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '61'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '35'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '44'}, {'groupId': 'FG006', 'numSubjects': '17'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'comment': 'One participant discontinued due to an AE, with an outcome of death.', 'groupId': 'FG001', 'numSubjects': '60'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '35'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '44'}, {'groupId': 'FG006', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '30'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '31'}, {'groupId': 'FG006', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '13'}, {'groupId': 'FG006', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Death', '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': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Adverse Event (AE) related to Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'AE not related to Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Caregiver Request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Investigator 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': 'Subject Request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Planned duration was approximately 110 weeks (including 6 week screening period, 52 weeks of dosing, and 52 weeks of follow-up). Participants who completed the 3134K1-200-EU (B2571004) study through Week 78 had the option to exit after this time point, for continued treatment and follow-up under extension protocol 3134K1-2203-EU (B2571007).', 'preAssignmentDetails': 'The Basic Results disclose pooled data from studies NCT00479557 and NCT00498602.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '44', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}, {'value': '245', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': 'ACC 3 µg+QS-21', 'description': 'Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'BG001', 'title': 'ACC 10 µg+QS-21', 'description': 'Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'BG002', 'title': 'ACC 30 µg+QS-21', 'description': 'Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'BG003', 'title': 'ACC 10 µg', 'description': 'Participants received 10 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'BG004', 'title': 'ACC 30 µg', 'description': 'Participants received 30 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'BG005', 'title': 'QS-21 Alone', 'description': 'Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'BG006', 'title': 'Phosphate Buffered Saline', 'description': 'Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.7', 'spread': '7.75', 'groupId': 'BG000'}, {'value': '69.3', 'spread': '9.57', 'groupId': 'BG001'}, {'value': '69.0', 'spread': '9.27', 'groupId': 'BG002'}, {'value': '71.9', 'spread': '8.96', 'groupId': 'BG003'}, {'value': '70.9', 'spread': '9.59', 'groupId': 'BG004'}, {'value': '68.8', 'spread': '8.07', 'groupId': 'BG005'}, {'value': '69.4', 'spread': '7.82', 'groupId': 'BG006'}, {'value': '69.1', 'spread': '8.87', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'year', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}, {'value': '139', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '106', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '43', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}, {'value': '236', 'groupId': 'BG007'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'number of participants'}, {'title': 'Mini-Mental State Examination (MMSE) Score', 'classes': [{'categories': [{'measurements': [{'value': '21.4', 'spread': '2.96', 'groupId': 'BG000'}, {'value': '21.4', 'spread': '3.38', 'groupId': 'BG001'}, {'value': '21.0', 'spread': '2.92', 'groupId': 'BG002'}, {'value': '21.6', 'spread': '3.16', 'groupId': 'BG003'}, {'value': '21.8', 'spread': '3.60', 'groupId': 'BG004'}, {'value': '21.7', 'spread': '3.11', 'groupId': 'BG005'}, {'value': '21.2', 'spread': '3.17', 'groupId': 'BG006'}, {'value': '21.4', 'spread': '3.13', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'description': 'The MMSE was used to systematically and thoroughly assess mental status of participants. It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The total score ranges from 0 to 30. A score of 23 or lower is indicative of cognitive impairment.', 'unitOfMeasure': 'score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'MMSE Stratum', 'classes': [{'title': 'High (21 - 26)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '29', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}, {'value': '161', 'groupId': 'BG007'}]}]}, {'title': 'Low (16 - 20)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '84', 'groupId': 'BG007'}]}]}], 'paramType': 'NUMBER', 'description': 'The MMSE was used to systematically and thoroughly assess mental status of participants. It is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The total score ranges from 0 to 30. A score of 23 or lower is indicative of cognitive impairment.', 'unitOfMeasure': 'number of participants'}], 'populationDescription': '245 participants were randomized in both studies (86 participants in 3134K1-200-EU \\[B2571004\\] and 159 participants in 3134K1-2201-US \\[B2571005\\]) and included in the analysis below. One participant of the randomized participants did not receive treatment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-30', 'studyFirstSubmitDate': '2007-05-24', 'resultsFirstSubmitDate': '2014-05-06', 'studyFirstSubmitQcDate': '2007-05-24', 'lastUpdatePostDateStruct': {'date': '2016-01-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-30', 'studyFirstPostDateStruct': {'date': '2007-05-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)', 'timeFrame': 'approximately 110 weeks, including a 6-week screening period, 52 weeks of dosing and 54 weeks for follow-up after the last dose.', 'description': "An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor's clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly."}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Titers (GMTs) of Anti-A-beta Immunoglobulin G (IgG) Total Using an Enzyme-linked Immunosorbent Assay (ELISA) at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104', 'timeFrame': 'Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104', 'description': 'The lower limit of quantification (LLOQ) was 100 U/mL and when the assay result was below LLOQ (100 U/mL), 50 U/mL was imputed for IgG.'}, {'measure': 'GMTs of Anti-A-beta Immunoglobulin M (IgM) Using ELISA at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104', 'timeFrame': 'Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104', 'description': 'The LLOQ was 50 U/mL and when the assay result was below LLOQ (50 U/mL), 25 U/mL was imputed for IgM.'}, {'measure': 'Change From Baseline GMTs of Anti-A-beta IgG Subtypes Using ELISA at Visits Where an IgG Total Response is Measurable (at Weeks 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104 if Applicable)', 'timeFrame': 'Baseline, Week 2, 4, 6, 8, 10, 14, 16, 24, 28, 30, 40, 50, 54, 56, 66, 78, 91, and 104', 'description': 'IgG subtypes were not assessed'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Alzheimer's Disease", 'active immunization'], 'conditions': ['Alzheimer Disease']}, 'referencesModule': {'references': [{'pmid': '26967206', 'type': 'DERIVED', 'citation': "Pasquier F, Sadowsky C, Holstein A, Leterme Gle P, Peng Y, Jackson N, Fox NC, Ketter N, Liu E, Ryan JM; ACC-001 (QS-21) Study Team. Two Phase 2 Multiple Ascending-Dose Studies of Vanutide Cridificar (ACC-001) and QS-21 Adjuvant in Mild-to-Moderate Alzheimer's Disease. J Alzheimers Dis. 2016;51(4):1131-43. doi: 10.3233/JAD-150376."}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3134K1-200&StudyName=Study%20Evaluating%20Safety%2C%20Tolerability%2C%20And%20Immunogenicity%20Of%20ACC-001%20In%20Subjects%20With%20Mild%20To%20Moderate%20Alzheimer%27s%20Disease', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': "To assess the safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization, in patients with mild to moderate Alzheimer's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of probable Alzheimer's Disease with Mini-Mental State Examination (MMSE) score of 16-26 (except Germany: 21-26)\n* Brain MRI consistent with Alzheimer Disease\n* Concurent use of Chloniesterase inhibitor or memantine allowed if stable\n* Other inclusion criteria apply\n\nExclusion Criteria:\n\n* Significant Neurological Disease other than Alzheimer's disease\n* Major psychiatric disorder\n* Contraindication to undergo brain MRI\n* Clinically significant systemic illness\n* Other exclusion criteria apply"}, 'identificationModule': {'nctId': 'NCT00479557', 'briefTitle': "Study Evaluating Safety, Tolerability, And Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': "A Phase Iia, 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 Subjects With Mild To Moderate Alzheimer's Disease", 'orgStudyIdInfo': {'id': '3134K1-200'}, 'secondaryIdInfos': [{'id': 'B2571004', 'type': 'OTHER', 'domain': 'Alias Study Number'}, {'id': '2006-002061-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'arm 1: ACC-001 (Vanutide Cridificar)+ QS-21', 'interventionNames': ['Biological: ACC-001 + QS-21']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'arm 2: ACC-001', 'interventionNames': ['Biological: ACC-001']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'arm 3: QS-21', 'interventionNames': ['Biological: QS-21']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'description': 'Drug: Phosphate Buffered Saline (PBS)', 'interventionNames': ['Drug: Placebo: Phosphate buffered saline']}], 'interventions': [{'name': 'ACC-001 + QS-21', 'type': 'BIOLOGICAL', 'description': 'Vanutide Cridificar (3, 10, 30µg) + QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12', 'armGroupLabels': ['1']}, {'name': 'ACC-001', 'type': 'BIOLOGICAL', 'description': 'Vanutide Cridificar (10, 30µg), IM on day 1, month 1, 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