Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT00996918
Status:
TERMINATED
Last Update Posted:
2014-01-01
First Post:
2009-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Long-Term Safety And Tolerability Study Of Bapineuzumab In Alzheimer Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Serbia']}, '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': 'C545458', 'term': 'bapineuzumab'}]}}, '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}, 'limitationsAndCaveats': {'description': 'Bapineuzumab program was discontinued prematurely. Efficacy results obtained after Week 78 are not presented due to the very small number of participants after this time point.'}}, 'adverseEventsModule': {'timeFrame': '2.6 years', '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': 'Placebo/Bapineuzumab 0.5 mg/kg', 'description': 'Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.', 'otherNumAtRisk': 39, 'otherNumAffected': 18, 'seriousNumAtRisk': 39, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg', 'description': 'Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.', 'otherNumAtRisk': 66, 'otherNumAffected': 21, 'seriousNumAtRisk': 66, 'seriousNumAffected': 10}, {'id': 'EG002', 'title': 'Placebo/Bapineuzumab 1.0 mg/kg', 'description': 'Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.', 'otherNumAtRisk': 37, 'otherNumAffected': 15, 'seriousNumAtRisk': 37, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg', 'description': 'Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.', 'otherNumAtRisk': 56, 'otherNumAffected': 15, 'seriousNumAtRisk': 56, 'seriousNumAffected': 11}, {'id': 'EG004', 'title': 'Bapineuzumab 2.0 mg/kg/Bapineuzumab 1.0 mg/kg', 'description': 'Participants originally randomized to 2.0 mg/kg bapineuzumab were reassigned to the 1.0 mg/kg dose level after discontinuation of 2.0 mg/kg dose level in the base study and continued the 1.0 mg/kg dose in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.', 'otherNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arteriosclerotic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Folate deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cerebral microhaemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cognitive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vasogenic cerebral oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Delusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chest injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Skull fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Polymyalgia rheumatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Metastatic squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pancreatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cerebellar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Partial seizures with secondary generalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vasogenic cerebral oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Disorientation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 56, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Reporting a Serious Adverse Event.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Bapineuzumab 0.5 mg/kg', 'description': 'Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'OG001', 'title': 'Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg', 'description': 'Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'OG002', 'title': 'Placebo/Bapineuzumab 1.0 mg/kg', 'description': 'Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'OG003', 'title': 'Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg', 'description': 'Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'OG004', 'title': 'Bapineuzumab 2.0 mg/kg/ Bapineuzumab 1.0 mg/kg', 'description': 'Participants originally randomized to 2.0 mg/kg bapineuzumab were reassigned to the 1.0 mg/kg dose level after discontinuation of 2.0 mg/kg dose level in the base study and continued the 1.0 mg/kg dose in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 195', 'description': 'Safety was measured according to standard adverse event collection as described in the Adverse Event Section of the Results. Complete tables of events are provided there.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included all participants who consented to participate in the extension and received at least one dose of the investigational product (in the extension study).'}, {'type': 'SECONDARY', 'title': "Change From Base Study Baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog/11) at Weeks 13, 26, 39, 52 and 78.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Bapineuzumab 0.5 mg/kg', 'description': 'Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'OG001', 'title': 'Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg', 'description': 'Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'OG002', 'title': 'Placebo/Bapineuzumab 1.0 mg/kg', 'description': 'Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'OG003', 'title': 'Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg', 'description': 'Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}], 'classes': [{'title': 'Week 13 (N = 38, 62, 33, 53)', 'categories': [{'measurements': [{'value': '7.47', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '6.17', 'spread': '0.95', 'groupId': 'OG001'}, {'value': '4.66', 'spread': '1.26', 'groupId': 'OG002'}, {'value': '6.45', 'spread': '0.98', 'groupId': 'OG003'}]}]}, {'title': 'Week 26 (N = 33, 54, 26, 45)', 'categories': [{'measurements': [{'value': '9.00', 'spread': '1.27', 'groupId': 'OG000'}, {'value': '7.49', 'spread': '1.03', 'groupId': 'OG001'}, {'value': '7.34', 'spread': '1.38', 'groupId': 'OG002'}, {'value': '7.30', 'spread': '1.07', 'groupId': 'OG003'}]}]}, {'title': 'Week 39 (N = 25, 46, 22, 37)', 'categories': [{'measurements': [{'value': '9.74', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '8.79', 'spread': '1.08', 'groupId': 'OG001'}, {'value': '7.92', 'spread': '1.45', 'groupId': 'OG002'}, {'value': '9.50', 'spread': '1.12', 'groupId': 'OG003'}]}]}, {'title': 'Week 52 (N = 18, 32, 15, 29)', 'categories': [{'measurements': [{'value': '12.44', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '10.38', 'spread': '1.35', 'groupId': 'OG001'}, {'value': '10.54', 'spread': '1.82', 'groupId': 'OG002'}, {'value': '10.31', 'spread': '1.36', 'groupId': 'OG003'}]}]}, {'title': 'Week 78 (N = 12, 19, 8, 20)', 'categories': [{'measurements': [{'value': '14.71', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '12.27', 'spread': '1.81', 'groupId': 'OG001'}, {'value': '15.46', 'spread': '2.46', 'groupId': 'OG002'}, {'value': '15.31', 'spread': '1.68', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.390', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.30', 'ciLowerLimit': '-4.29', 'ciUpperLimit': '1.68', 'groupDescription': 'Change from base study baseline in ADAS-Cog score at Week 13.\n\nResults are from a restricted maximum likelihood (REML)-based mixed model for repeated measures (MMRM) with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.264', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.80', 'ciLowerLimit': '-1.37', 'ciUpperLimit': '4.97', 'groupDescription': 'Change from base study baseline in ADAS-Cog score at Week 13.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.357', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.51', 'ciLowerLimit': '-4.74', 'ciUpperLimit': '1.72', 'groupDescription': 'Change from base study baseline in ADAS-Cog score at Week 26.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.981', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-3.50', 'ciUpperLimit': '3.42', 'groupDescription': 'Change from base study baseline in ADAS-Cog score at Week 26.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.584', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.95', 'ciLowerLimit': '-4.37', 'ciUpperLimit': '2.47', 'groupDescription': 'Change from base study baseline in ADAS-Cog score at Week 39.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.392', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.58', 'ciLowerLimit': '-2.05', 'ciUpperLimit': '5.20', 'groupDescription': 'Change from base study baseline in ADAS-Cog score at Week 39.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.345', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.05', 'ciLowerLimit': '-6.34', 'ciUpperLimit': '2.24', 'groupDescription': 'Change from base study baseline in ADAS-Cog score at Week 52.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.922', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-4.73', 'ciUpperLimit': '4.28', 'groupDescription': 'Change from base study baseline in ADAS-Cog score at Week 52.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.384', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.44', 'ciLowerLimit': '-7.97', 'ciUpperLimit': '3.10', 'groupDescription': 'Change from base study baseline in ADAS-Cog score at Week 78.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.961', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-6.08', 'ciUpperLimit': '5.78', 'groupDescription': 'Change from base study baseline in ADAS-Cog score at Week 78.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 13, 26, 39, 52 and 78', 'description': 'The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4) constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8) remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension.This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.'}, {'type': 'SECONDARY', 'title': 'Change From Extension Study Baseline in ADAS-Cog/11 at Weeks 13, 26, 39, 52 and 78.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Bapineuzumab 0.5 mg/kg', 'description': 'Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'OG001', 'title': 'Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg', 'description': 'Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'OG002', 'title': 'Placebo/Bapineuzumab 1.0 mg/kg', 'description': 'Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'OG003', 'title': 'Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg', 'description': 'Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}], 'classes': [{'title': 'Week 13 (N = 38, 62, 33, 53)', 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '0.68', 'groupId': 'OG001'}, {'value': '-1.68', 'spread': '0.90', 'groupId': 'OG002'}, {'value': '0.46', 'spread': '0.70', 'groupId': 'OG003'}]}]}, {'title': 'Week 26 (N = 33, 54, 26, 45)', 'categories': [{'measurements': [{'value': '1.61', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '1.63', 'spread': '0.75', 'groupId': 'OG001'}, {'value': '1.08', 'spread': '1.01', 'groupId': 'OG002'}, {'value': '1.37', 'spread': '0.78', 'groupId': 'OG003'}]}]}, {'title': 'Week 39 (N = 25, 46, 22, 37)', 'categories': [{'measurements': [{'value': '2.35', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '2.86', 'spread': '0.79', 'groupId': 'OG001'}, {'value': '1.68', 'spread': '1.07', 'groupId': 'OG002'}, {'value': '3.62', 'spread': '0.83', 'groupId': 'OG003'}]}]}, {'title': 'Week 52 (N = 18, 32, 15, 29)', 'categories': [{'measurements': [{'value': '4.85', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '4.45', 'spread': '1.14', 'groupId': 'OG001'}, {'value': '4.30', 'spread': '1.55', 'groupId': 'OG002'}, {'value': '4.43', 'spread': '1.14', 'groupId': 'OG003'}]}]}, {'title': 'Week 78 (N = 12, 19, 8, 20)', 'categories': [{'measurements': [{'value': '7.29', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '6.73', 'spread': '1.57', 'groupId': 'OG001'}, {'value': '8.86', 'spread': '2.15', 'groupId': 'OG002'}, {'value': '9.68', 'spread': '1.42', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.837', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.22', 'ciLowerLimit': '-1.91', 'ciUpperLimit': '2.35', 'groupDescription': 'Change from extension study baseline in ADAS-Cog score at Week 13.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.064', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.14', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '4.41', 'groupDescription': 'Change from extension study baseline in ADAS-Cog score at Week 13.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.990', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-2.32', 'ciUpperLimit': '2.35', 'groupDescription': 'Change from extension study baseline in ADAS-Cog score at Week 26.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.817', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.30', 'ciLowerLimit': '-2.22', 'ciUpperLimit': '2.82', 'groupDescription': 'Change from extension study baseline in ADAS-Cog score at Week 26.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.697', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '-2.04', 'ciUpperLimit': '3.05', 'groupDescription': 'Change from extension study baseline in ADAS-Cog score at Week 39.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.158', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.93', 'ciLowerLimit': '-0.76', 'ciUpperLimit': '4.63', 'groupDescription': 'Change from extension study baseline in ADAS-Cog score at Week 39.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.829', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.40', 'ciLowerLimit': '-4.06', 'ciUpperLimit': '3.26', 'groupDescription': 'Change from extension study baseline in ADAS-Cog score at Week 52.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.950', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-3.69', 'ciUpperLimit': '3.93', 'groupDescription': 'Change from extension study baseline in ADAS-Cog score at Week 52.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.816', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.56', 'ciLowerLimit': '-5.35', 'ciUpperLimit': '4.23', 'groupDescription': 'Change from extension study baseline in ADAS-Cog score at Week 78.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.751', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '-4.32', 'ciUpperLimit': '5.96', 'groupDescription': 'Change from extension study baseline in ADAS-Cog score at Week 78.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 13, 26, 39, 52 and 78', 'description': 'The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4) constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8) remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension.This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.'}, {'type': 'SECONDARY', 'title': 'Change From Base Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Bapineuzumab 0.5 mg/kg', 'description': 'Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'OG001', 'title': 'Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg', 'description': 'Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'OG002', 'title': 'Placebo/Bapineuzumab 1.0 mg/kg', 'description': 'Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'OG003', 'title': 'Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg', 'description': 'Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}], 'classes': [{'title': 'Week 13 (N = 38, 62, 31, 52)', 'categories': [{'measurements': [{'value': '-18.75', 'spread': '2.88', 'groupId': 'OG000'}, {'value': '-18.60', 'spread': '2.36', 'groupId': 'OG001'}, {'value': '-15.50', 'spread': '3.13', 'groupId': 'OG002'}, {'value': '-13.36', 'spread': '2.43', 'groupId': 'OG003'}]}]}, {'title': 'Week 26 (N = 33, 56, 26, 44)', 'categories': [{'measurements': [{'value': '-21.19', 'spread': '2.93', 'groupId': 'OG000'}, {'value': '-21.04', 'spread': '2.38', 'groupId': 'OG001'}, {'value': '-16.26', 'spread': '3.19', 'groupId': 'OG002'}, {'value': '-19.18', 'spread': '2.48', 'groupId': 'OG003'}]}]}, {'title': 'Week 39 (N = 25, 46, 21, 37)', 'categories': [{'measurements': [{'value': '-25.42', 'spread': '3.14', 'groupId': 'OG000'}, {'value': '-27.36', 'spread': '2.51', 'groupId': 'OG001'}, {'value': '-14.57', 'spread': '3.39', 'groupId': 'OG002'}, {'value': '-19.10', 'spread': '2.62', 'groupId': 'OG003'}]}]}, {'title': 'Week 52 (N = 18, 32, 15, 30)', 'categories': [{'measurements': [{'value': '-29.52', 'spread': '3.48', 'groupId': 'OG000'}, {'value': '-28.00', 'spread': '2.77', 'groupId': 'OG001'}, {'value': '-20.41', 'spread': '3.74', 'groupId': 'OG002'}, {'value': '-23.21', 'spread': '2.80', 'groupId': 'OG003'}]}]}, {'title': 'Week 78 (N = 12, 20, 8, 20)', 'categories': [{'measurements': [{'value': '-36.48', 'spread': '4.56', 'groupId': 'OG000'}, {'value': '-35.75', 'spread': '3.79', 'groupId': 'OG001'}, {'value': '-25.21', 'spread': '5.24', 'groupId': 'OG002'}, {'value': '-30.28', 'spread': '3.65', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.967', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.16', 'ciLowerLimit': '-7.22', 'ciUpperLimit': '7.53', 'groupDescription': 'Change from base study baseline in DAD score at Week 13.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.593', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.13', 'ciLowerLimit': '-5.72', 'ciUpperLimit': '9.98', 'groupDescription': 'Change from base study baseline in DAD score at Week 13.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.968', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '-7.32', 'ciUpperLimit': '7.62', 'groupDescription': 'Change from base study baseline in DAD score at Week 26.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.473', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.92', 'ciLowerLimit': '-10.92', 'ciUpperLimit': '5.08', 'groupDescription': 'Change from base study baseline in DAD score at Week 26.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.630', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.95', 'ciLowerLimit': '-9.91', 'ciUpperLimit': '6.02', 'groupDescription': 'Change from base study baseline in DAD score at Week 39.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.293', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.53', 'ciLowerLimit': '-13.02', 'ciUpperLimit': '3.95', 'groupDescription': 'Change from base study baseline in DAD score at Week 39.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.733', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.53', 'ciLowerLimit': '-7.28', 'ciUpperLimit': '10.33', 'groupDescription': 'Change from base study baseline in DAD score at Week 52.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.550', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.81', 'ciLowerLimit': '-12.06', 'ciUpperLimit': '6.45', 'groupDescription': 'Change from base study baseline in DAD score at Week 52.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.902', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '-11.04', 'ciUpperLimit': '12.50', 'groupDescription': 'Change from base study baseline in DAD score at Week 78.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.430', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.07', 'ciLowerLimit': '-17.75', 'ciUpperLimit': '7.61', 'groupDescription': 'Change from base study baseline in DAD score at Week 78.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 13, 26, 39, 52 and 78', 'description': "The DAD measures instrumental and basic activities of daily living in participants with Alzheimer's Disease (AD). The DAD is administered to the participants'caregiver in the form of an interview. This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced by the participant. This scale assesses a participants' ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.'}, {'type': 'SECONDARY', 'title': 'Change From Extension Study Baseline in DAD Score at Weeks 13, 26, 39, 52 and 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Bapineuzumab 0.5 mg/kg', 'description': 'Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'OG001', 'title': 'Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg', 'description': 'Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'OG002', 'title': 'Placebo/Bapineuzumab 1.0 mg/kg', 'description': 'Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'OG003', 'title': 'Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg', 'description': 'Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}], 'classes': [{'title': 'Week 13 (N = 38, 62, 31, 52)', 'categories': [{'measurements': [{'value': '-3.80', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '-4.83', 'spread': '1.60', 'groupId': 'OG001'}, {'value': '-5.17', 'spread': '2.16', 'groupId': 'OG002'}, {'value': '-1.48', 'spread': '1.65', 'groupId': 'OG003'}]}]}, {'title': 'Week 26 (N = 33, 56, 26, 44)', 'categories': [{'measurements': [{'value': '-6.33', 'spread': '2.02', 'groupId': 'OG000'}, {'value': '-7.22', 'spread': '1.64', 'groupId': 'OG001'}, {'value': '-5.75', 'spread': '2.23', 'groupId': 'OG002'}, {'value': '-7.25', 'spread': '1.73', 'groupId': 'OG003'}]}]}, {'title': 'Week 39 (N = 25, 46, 21, 37)', 'categories': [{'measurements': [{'value': '-11.14', 'spread': '2.23', 'groupId': 'OG000'}, {'value': '-13.49', 'spread': '1.76', 'groupId': 'OG001'}, {'value': '-4.34', 'spread': '2.41', 'groupId': 'OG002'}, {'value': '-7.08', 'spread': '1.85', 'groupId': 'OG003'}]}]}, {'title': 'Week 52 (N = 18, 32, 15, 30)', 'categories': [{'measurements': [{'value': '-16.21', 'spread': '2.57', 'groupId': 'OG000'}, {'value': '-13.77', 'spread': '2.02', 'groupId': 'OG001'}, {'value': '-10.02', 'spread': '2.75', 'groupId': 'OG002'}, {'value': '-11.06', 'spread': '2.02', 'groupId': 'OG003'}]}]}, {'title': 'Week 78 (N = 12, 20, 8, 20)', 'categories': [{'measurements': [{'value': '-23.40', 'spread': '3.01', 'groupId': 'OG000'}, {'value': '-21.30', 'spread': '2.54', 'groupId': 'OG001'}, {'value': '-14.54', 'spread': '3.54', 'groupId': 'OG002'}, {'value': '-17.41', 'spread': '2.37', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.683', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.03', 'ciLowerLimit': '-6.01', 'ciUpperLimit': '3.95', 'groupDescription': 'Change from extension study baseline in DAD score at Week 13.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.177', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.69', 'ciLowerLimit': '-1.68', 'ciUpperLimit': '9.06', 'groupDescription': 'Change from extension study baseline in DAD score at Week 13.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.734', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.89', 'ciLowerLimit': '-6.03', 'ciUpperLimit': '4.25', 'groupDescription': 'Change from extension study baseline in DAD score at Week 26.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.595', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.50', 'ciLowerLimit': '-7.06', 'ciUpperLimit': '4.05', 'groupDescription': 'Change from extension study baseline in DAD score at Week 26.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.409', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.35', 'ciLowerLimit': '-7.95', 'ciUpperLimit': '3.24', 'groupDescription': 'Change from extension study baseline in DAD score at Week 39.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.368', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.74', 'ciLowerLimit': '-8.73', 'ciUpperLimit': '3.24', 'groupDescription': 'Change from extension study baseline in DAD score at Week 39.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.458', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.44', 'ciLowerLimit': '-4.01', 'ciUpperLimit': '8.89', 'groupDescription': 'Change from extension study baseline in DAD score at Week 52.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.760', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.04', 'ciLowerLimit': '-7.77', 'ciUpperLimit': '5.68', 'groupDescription': 'Change from extension study baseline in DAD score at Week 52.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.597', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.09', 'ciLowerLimit': '-5.67', 'ciUpperLimit': '9.86', 'groupDescription': 'Change from extension study baseline in DAD score at Week 78.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.501', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.87', 'ciLowerLimit': '-11.24', 'ciUpperLimit': '5.50', 'groupDescription': 'Change from extension study baseline in DAD score at Week 78.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 13, 26, 39, 52 and 78', 'description': "The DAD measures instrumental and basic activities of daily living in participants with AD. The DAD is administered to the participants'caregiver in the form of an interview. This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced by the participant. This scale assesses a participants' ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.'}, {'type': 'SECONDARY', 'title': 'Change From Base Study Baseline in Neuropsychiatric Inventory (NPI) Score at Weeks 26, 52 and 78.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Bapineuzumab 0.5 mg/kg', 'description': 'Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'OG001', 'title': 'Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg', 'description': 'Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'OG002', 'title': 'Placebo/Bapineuzumab 1.0 mg/kg', 'description': 'Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'OG003', 'title': 'Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg', 'description': 'Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}], 'classes': [{'title': 'Week 26 (N = 36, 59, 30, 51)', 'categories': [{'measurements': [{'value': '4.57', 'spread': '2.08', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '1.70', 'groupId': 'OG001'}, {'value': '4.71', 'spread': '2.26', 'groupId': 'OG002'}, {'value': '4.43', 'spread': '1.75', 'groupId': 'OG003'}]}]}, {'title': 'Week 52 (N = 21, 37, 17, 32)', 'categories': [{'measurements': [{'value': '4.99', 'spread': '2.60', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '2.05', 'groupId': 'OG001'}, {'value': '4.23', 'spread': '2.80', 'groupId': 'OG002'}, {'value': '6.57', 'spread': '2.08', 'groupId': 'OG003'}]}]}, {'title': 'Week 78 (N = 13, 18, 8, 20)', 'categories': [{'measurements': [{'value': '16.17', 'spread': '3.23', 'groupId': 'OG000'}, {'value': '3.31', 'spread': '2.94', 'groupId': 'OG001'}, {'value': '5.24', 'spread': '4.02', 'groupId': 'OG002'}, {'value': '6.70', 'spread': '2.61', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.183', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.60', 'ciLowerLimit': '-8.91', 'ciUpperLimit': '1.71', 'groupDescription': 'Change from base study baseline in NPI score at Week 26.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.920', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-5.92', 'ciUpperLimit': '5.35', 'groupDescription': 'Change from base study baseline in NPI score at Week 26.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.133', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.99', 'ciLowerLimit': '-11.52', 'ciUpperLimit': '1.53', 'groupDescription': 'Change from base study baseline in NPI score at Week 52.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.505', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.34', 'ciLowerLimit': '-4.55', 'ciUpperLimit': '9.22', 'groupDescription': 'Change from base study baseline in NPI score at Week 52.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.86', 'ciLowerLimit': '-21.46', 'ciUpperLimit': '-4.25', 'groupDescription': 'Change from base study baseline in NPI score at Week 78.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.760', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.47', 'ciLowerLimit': '-7.95', 'ciUpperLimit': '10.88', 'groupDescription': 'Change from base study baseline in NPI score at Week 78.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 26, 52 and 78', 'description': 'NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency\\*severity=each domain score(range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.'}, {'type': 'SECONDARY', 'title': 'Change From Extension Study Baseline in NPI Score at Weeks 26, 52 and 78.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Bapineuzumab 0.5 mg/kg', 'description': 'Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'OG001', 'title': 'Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg', 'description': 'Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'OG002', 'title': 'Placebo/Bapineuzumab 1.0 mg/kg', 'description': 'Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'OG003', 'title': 'Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg', 'description': 'Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}], 'classes': [{'title': 'Week 26 (N = 36, 60, 30, 51)', 'categories': [{'measurements': [{'value': '2.29', 'spread': '1.79', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '1.48', 'groupId': 'OG001'}, {'value': '2.77', 'spread': '1.96', 'groupId': 'OG002'}, {'value': '1.73', 'spread': '1.51', 'groupId': 'OG003'}]}]}, {'title': 'Week 52 (N = 21, 37, 17, 32)', 'categories': [{'measurements': [{'value': '2.34', 'spread': '2.45', 'groupId': 'OG000'}, {'value': '-1.06', 'spread': '1.94', 'groupId': 'OG001'}, {'value': '3.78', 'spread': '2.65', 'groupId': 'OG002'}, {'value': '3.99', 'spread': '1.97', 'groupId': 'OG003'}]}]}, {'title': 'Week 78 (N = 13, 18, 8, 20)', 'categories': [{'measurements': [{'value': '11.76', 'spread': '4.86', 'groupId': 'OG000'}, {'value': '1.70', 'spread': '4.40', 'groupId': 'OG001'}, {'value': '2.28', 'spread': '6.07', 'groupId': 'OG002'}, {'value': '4.76', 'spread': '3.93', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.373', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.08', 'ciLowerLimit': '-6.68', 'ciUpperLimit': '2.52', 'groupDescription': 'Change from extension study baseline in NPI score at Week 26.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.677', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.03', 'ciLowerLimit': '-5.92', 'ciUpperLimit': '3.86', 'groupDescription': 'Change from extension study baseline in NPI score at Week 26.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.280', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.40', 'ciLowerLimit': '-9.61', 'ciUpperLimit': '2.80', 'groupDescription': 'Change from extension study baseline in NPI score at Week 52.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.950', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '-6.34', 'ciUpperLimit': '6.76', 'groupDescription': 'Change from extension study baseline in NPI score at Week 52.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.130', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.06', 'ciLowerLimit': '-23.16', 'ciUpperLimit': '3.05', 'groupDescription': 'Change from extension study baseline in NPI score at Week 78.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.732', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.48', 'ciLowerLimit': '-11.97', 'ciUpperLimit': '16.94', 'groupDescription': 'Change from extension study baseline in NPI score at Week 78.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 26, 52 and 78', 'description': 'NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency\\*severity=each domain score(range 0-12). Total score=sum of each domain score(range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.'}, {'type': 'SECONDARY', 'title': 'Change From Base Study Baseline in Mini-mental State Examination (MMSE) Score at Weeks 6, 19, 32, 45 and 78.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Bapineuzumab 0.5 mg/kg', 'description': 'Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'OG001', 'title': 'Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg', 'description': 'Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'OG002', 'title': 'Placebo/Bapineuzumab 1.0 mg/kg', 'description': 'Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'OG003', 'title': 'Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg', 'description': 'Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}], 'classes': [{'title': 'Week 6 (N = 38, 61, 33, 53)', 'categories': [{'measurements': [{'value': '-2.89', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '-2.85', 'spread': '0.37', 'groupId': 'OG001'}, {'value': '-2.02', 'spread': '0.49', 'groupId': 'OG002'}, {'value': '-2.22', 'spread': '0.39', 'groupId': 'OG003'}]}]}, {'title': 'Week 19 (N = 36, 59, 28, 50)', 'categories': [{'measurements': [{'value': '-2.80', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '-2.66', 'spread': '0.38', 'groupId': 'OG001'}, {'value': '-2.76', 'spread': '0.51', 'groupId': 'OG002'}, {'value': '-3.29', 'spread': '0.39', 'groupId': 'OG003'}]}]}, {'title': 'Week 32 (N = 32, 51, 26, 41)', 'categories': [{'measurements': [{'value': '-3.82', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '-3.43', 'spread': '0.40', 'groupId': 'OG001'}, {'value': '-4.40', 'spread': '0.53', 'groupId': 'OG002'}, {'value': '-3.88', 'spread': '0.42', 'groupId': 'OG003'}]}]}, {'title': 'Week 45 (N = 23, 41, 21, 35)', 'categories': [{'measurements': [{'value': '-4.86', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '-4.13', 'spread': '0.44', 'groupId': 'OG001'}, {'value': '-4.63', 'spread': '0.58', 'groupId': 'OG002'}, {'value': '-4.51', 'spread': '0.46', 'groupId': 'OG003'}]}]}, {'title': 'Week 78 (N = 13, 27, 11, 21)', 'categories': [{'measurements': [{'value': '-7.62', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '-5.10', 'spread': '0.54', 'groupId': 'OG001'}, {'value': '-6.97', 'spread': '0.75', 'groupId': 'OG002'}, {'value': '-4.89', 'spread': '0.56', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.938', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-1.12', 'ciUpperLimit': '1.21', 'groupDescription': 'Change from base study baseline in MMSE score at Week 6.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.753', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-1.43', 'ciUpperLimit': '1.04', 'groupDescription': 'Change from base study baseline in MMSE score at Week 6.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.809', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '-1.04', 'ciUpperLimit': '1.33', 'groupDescription': 'Change from base study baseline in MMSE score at Week 19.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.421', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.52', 'ciLowerLimit': '-1.80', 'ciUpperLimit': '0.75', 'groupDescription': 'Change from base study baseline in MMSE score at Week 19.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.535', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '-0.85', 'ciUpperLimit': '1.63', 'groupDescription': 'Change from base study baseline in MMSE score at Week 32.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.445', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.52', 'ciLowerLimit': '-0.82', 'ciUpperLimit': '1.86', 'groupDescription': 'Change from base study baseline in MMSE score at Week 32.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.309', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '-0.67', 'ciUpperLimit': '2.12', 'groupDescription': 'Change from base study baseline in MMSE score at Week 45.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.872', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-1.34', 'ciUpperLimit': '1.57', 'groupDescription': 'Change from base study baseline in MMSE score at Week 45.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.52', 'ciLowerLimit': '0.79', 'ciUpperLimit': '4.26', 'groupDescription': 'Change from base study baseline in MMSE score at Week 78.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.026', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.09', 'ciLowerLimit': '0.25', 'ciUpperLimit': '3.93', 'groupDescription': 'Change from base study baseline in MMSE score at Week 78.\n\nResults are from a REML-based MMRM with change from base study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 6, 19, 32, 45 and 78', 'description': 'MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Extension mITT Population was defined as all randomly assigned participants who received at least one dose of investigational product in the extension study and who had a baseline for the extension study and at least one valid post-baseline assessment of the ADAS-Cog total score and DAD total score in the extension study.'}, {'type': 'SECONDARY', 'title': 'Change From Extension Study Baseline in MMSE Score at Weeks 6, 19, 32, 45 and 78.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo/Bapineuzumab 0.5 mg/kg', 'description': 'Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'OG001', 'title': 'Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg', 'description': 'Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'OG002', 'title': 'Placebo/Bapineuzumab 1.0 mg/kg', 'description': 'Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'OG003', 'title': 'Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg', 'description': 'Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}], 'classes': [{'title': 'Week 6 (N = 38, 61, 33, 53)', 'categories': [{'measurements': [{'value': '-1.20', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '-0.80', 'spread': '0.38', 'groupId': 'OG001'}, {'value': '0.11', 'spread': '0.50', 'groupId': 'OG002'}, {'value': '-0.23', 'spread': '0.39', 'groupId': 'OG003'}]}]}, {'title': 'Week 19 (N = 36, 59, 28, 50)', 'categories': [{'measurements': [{'value': '-1.10', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '-0.64', 'spread': '0.38', 'groupId': 'OG001'}, {'value': '-0.62', 'spread': '0.52', 'groupId': 'OG002'}, {'value': '-1.32', 'spread': '0.39', 'groupId': 'OG003'}]}]}, {'title': 'Week 32 (N = 32, 51, 26, 41)', 'categories': [{'measurements': [{'value': '-2.11', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '-1.45', 'spread': '0.40', 'groupId': 'OG001'}, {'value': '-2.18', 'spread': '0.54', 'groupId': 'OG002'}, {'value': '-1.93', 'spread': '0.42', 'groupId': 'OG003'}]}]}, {'title': 'Week 45 (N = 23, 41, 21, 35)', 'categories': [{'measurements': [{'value': '-3.06', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '-2.13', 'spread': '0.45', 'groupId': 'OG001'}, {'value': '-2.39', 'spread': '0.59', 'groupId': 'OG002'}, {'value': '-2.62', 'spread': '0.46', 'groupId': 'OG003'}]}]}, {'title': 'Week 78 (N = 13, 27, 11, 21)', 'categories': [{'measurements': [{'value': '-5.68', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '-3.22', 'spread': '0.54', 'groupId': 'OG001'}, {'value': '-4.73', 'spread': '0.77', 'groupId': 'OG002'}, {'value': '-2.97', 'spread': '0.56', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.504', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.40', 'ciLowerLimit': '-0.77', 'ciUpperLimit': '1.57', 'groupDescription': 'Change from extension study baseline in MMSE score at Week 6.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.592', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-1.58', 'ciUpperLimit': '0.90', 'groupDescription': 'Change from extension study baseline in MMSE score at Week 6.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.441', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.47', 'ciLowerLimit': '-0.72', 'ciUpperLimit': '1.65', 'groupDescription': 'Change from extension study baseline in MMSE score at Week 19.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.288', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.69', 'ciLowerLimit': '-1.97', 'ciUpperLimit': '0.59', 'groupDescription': 'Change from extension study baseline in MMSE score at Week 19.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.303', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '1.90', 'groupDescription': 'Change from extension study baseline in MMSE score at Week 32.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.713', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '-1.09', 'ciUpperLimit': '1.60', 'groupDescription': 'Change from extension study baseline in MMSE score at Week 32.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.198', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '-0.49', 'ciUpperLimit': '2.34', 'groupDescription': 'Change from extension study baseline in MMSE score at Week 45.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.756', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.23', 'ciLowerLimit': '-1.70', 'ciUpperLimit': '1.24', 'groupDescription': 'Change from extension study baseline in MMSE score at Week 45.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.45', 'ciLowerLimit': '0.69', 'ciUpperLimit': '4.22', 'groupDescription': 'Change from extension study baseline in MMSE score at Week 78.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.066', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.75', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '3.62', 'groupDescription': 'Change from extension study baseline in MMSE score at Week 78.\n\nResults are from a REML based MMRM with change from extension study baseline as the response and the following fixed effect model terms: treatment, visit (scheduled week), treatment-by-visit interaction, baseline value of the response variable, baseline MMSE total score stratum and cholinesterase inhibitor or memantine use stratum.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Weeks 6, 19, 32, 45 and 78', 'description': 'MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo/Bapineuzumab 0.5 Milligram/Kilogram(mg/kg)', 'description': 'Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'FG001', 'title': 'Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg', 'description': 'Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'FG002', 'title': 'Placebo/Bapineuzumab 1.0 mg/kg', 'description': 'Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'FG003', 'title': 'Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg', 'description': 'Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'FG004', 'title': 'Bapineuzumab 2.0 mg/kg/ Bapineuzumab 1.0 mg/kg', 'description': 'Participants originally randomized to 2.0 mg/kg bapineuzumab were reassigned to the 1.0 mg/kg dose level after discontinuation of 2.0 mg/kg dose level in the base study and continued the 1.0 mg/kg dose in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '37'}, {'groupId': 'FG003', 'numSubjects': '56'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '37'}, {'groupId': 'FG003', 'numSubjects': '56'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '37'}, {'groupId': 'FG003', 'numSubjects': '56'}, {'groupId': 'FG004', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Discontinuation of Study by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '45'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Loss of Caregiver', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This extension study was conducted at 91 centers in 17 countries. The study was terminated early by the sponsor on 06 August 2012. Participants who had not completed the final follow-up visit prior to 06 August 2012 were asked to complete an early termination visit.', 'preAssignmentDetails': 'Participants who had completed the base study protocol 3133K1-3000 were allowed to participate in this extension study. Participants who developed vasogenic edema during study 3133K1-3000 were considered for study 3133K1-3002 participation if the abnormality was resolved and the participant met criteria to resume the investigational product.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '190', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo/Bapineuzumab 0.5 mg/kg', 'description': 'Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'BG001', 'title': 'Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg', 'description': 'Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'BG002', 'title': 'Placebo/Bapineuzumab 1.0 mg/kg', 'description': 'Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'BG003', 'title': 'Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg', 'description': 'Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'BG004', 'title': 'Bapineuzumab 2.0 mg/kg/Bapineuzumab 1.0 mg/kg', 'description': 'Participants originally randomized to 2.0 mg/kg bapineuzumab were reassigned to the 1.0 mg/kg dose level after discontinuation of 2.0 mg/kg dose level in the base study and continued the 1.0 mg/kg dose in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.9', 'spread': '9.70', 'groupId': 'BG000'}, {'value': '71.9', 'spread': '8.83', 'groupId': 'BG001'}, {'value': '68.8', 'spread': '8.59', 'groupId': 'BG002'}, {'value': '70.6', 'spread': '9.13', 'groupId': 'BG003'}, {'value': '71.3', 'spread': '10.63', 'groupId': 'BG004'}, {'value': '70.4', 'spread': '9.08', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 65', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '62', 'groupId': 'BG005'}]}]}, {'title': '>= 65', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '128', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Number of participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '77', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '113', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 198}}, 'statusModule': {'whyStopped': 'The study was terminated on August 6, 2012, because 2 large Phase 3 studies showed no clinical benefit. This decision was not based on any new safety concerns.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-12', 'studyFirstSubmitDate': '2009-10-14', 'resultsFirstSubmitDate': '2013-11-12', 'studyFirstSubmitQcDate': '2009-10-15', 'lastUpdatePostDateStruct': {'date': '2014-01-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-12', 'studyFirstPostDateStruct': {'date': '2009-10-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Reporting a Serious Adverse Event.', 'timeFrame': 'Up to Week 195', 'description': 'Safety was measured according to standard adverse event collection as described in the Adverse Event Section of the Results. Complete tables of events are provided there.'}], 'secondaryOutcomes': [{'measure': "Change From Base Study Baseline in Alzheimer's Disease Assesment Scale-Cognitive Subscale (ADAS-Cog/11) at Weeks 13, 26, 39, 52 and 78.", 'timeFrame': 'Weeks 13, 26, 39, 52 and 78', 'description': 'The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4) constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8) remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension.This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.'}, {'measure': 'Change From Extension Study Baseline in ADAS-Cog/11 at Weeks 13, 26, 39, 52 and 78.', 'timeFrame': 'Weeks 13, 26, 39, 52 and 78', 'description': 'The ADAS-Cog is a multi-item, objective measure of cognitive function. The scale evaluates memory, language, and praxis with items such as orientation, word recall, word recognition, object identification, comprehension, and the completion of simple tasks. Analysis of the ADAS-Cog for this study was based upon an 11 item score from the following items 1) word recall task, 2) naming objects and fingers, 3) following commands, 4) constructional praxis, 5) ideational praxis, 6) orientation, 7) word recognition, 8) remembering test instructions, 9) spoken language ability, 10) word finding difficulty in spontaneous speech, and 11) comprehension.This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced. The ADAS-Cog/11 ranged from 0 to 70 points, with higher scores indicating a greater degree of impairment. A negative change from baseline indicates a decrease in cognitive impairment.'}, {'measure': 'Change From Base Study Baseline in Disability Assessment for Dementia (DAD) Score at Weeks 13, 26, 39, 52 and 78.', 'timeFrame': 'Weeks 13, 26, 39, 52 and 78', 'description': "The DAD measures instrumental and basic activities of daily living in participants with Alzheimer's Disease (AD). The DAD is administered to the participants'caregiver in the form of an interview. This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced by the participant. This scale assesses a participants' ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement"}, {'measure': 'Change From Extension Study Baseline in DAD Score at Weeks 13, 26, 39, 52 and 78', 'timeFrame': 'Weeks 13, 26, 39, 52 and 78', 'description': "The DAD measures instrumental and basic activities of daily living in participants with AD. The DAD is administered to the participants'caregiver in the form of an interview. This scale had to be administered by a trained and certified psychometric rater who did not have access to any information regarding adverse events experienced by the participant. This scale assesses a participants' ability to initiate, plan, and perform activities related to hygiene, dressing, continence, eating, meal preparation, telephoning, going on an outing, finance and correspondence, medications, leisure, and housework. Each item can be scored as 1 = yes, 0 = no, non applicable = NA. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores indicate better function; a positive change from baseline indicates an improvement"}, {'measure': 'Change From Base Study Baseline in Neuropsychiatric Inventory (NPI) Score at Weeks 26, 52 and 78.', 'timeFrame': 'Weeks 26, 52 and 78', 'description': 'NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, nighttime behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency\\*severity=each domain score(range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.'}, {'measure': 'Change From Extension Study Baseline in NPI Score at Weeks 26, 52 and 78.', 'timeFrame': 'Weeks 26, 52 and 78', 'description': 'NPI:12-domain caregiver assessment of behavioral disturbances occurring in dementia: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating, night-time behavior. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency\\*severity=each domain score(range 0-12). Total score=sum of each domain score(range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.'}, {'measure': 'Change From Base Study Baseline in Mini-mental State Examination (MMSE) Score at Weeks 6, 19, 32, 45 and 78.', 'timeFrame': 'Weeks 6, 19, 32, 45 and 78', 'description': 'MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state.'}, {'measure': 'Change From Extension Study Baseline in MMSE Score at Weeks 6, 19, 32, 45 and 78.', 'timeFrame': 'Weeks 6, 19, 32, 45 and 78', 'description': 'MMSE measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['antibody'], 'conditions': ['Alzheimer Disease']}, 'referencesModule': {'references': [{'pmid': '27334799', 'type': 'DERIVED', 'citation': "Ivanoiu A, Pariente J, Booth K, Lobello K, Luscan G, Hua L, Lucas P, Styren S, Yang L, Li D, Black RS, Brashear HR, McRae T. Long-term safety and tolerability of bapineuzumab in patients with Alzheimer's disease in two phase 3 extension studies. Alzheimers Res Ther. 2016 Jun 23;8(1):24. doi: 10.1186/s13195-016-0193-y."}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3133K1-3002&StudyName=A%20Long-Term%20Safety%20And%20Tolerability%20Study%20Of%20Bapineuzumab%20In%20Alzheimer%20Disease%20Patients', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to assess the long-term safety and tolerability of bapineuzumab in subjects with Alzheimer Disease who participated in study 3133K1-3000 (NCT00667810). Over 250 sites will participate in over 26 countries. Subjects will receive bapineuzumab. Each subject's participation will last approximately 4 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '51 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject has completed study 3133K1-3000 and brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of Alzheimer Disease\n* Mini-Mental Status Examination (MMSE) \\>=10 at screening\n* Caregiver able to attend all clinic visits with subject\n\nExclusion Criteria:\n\n* Any medical or psychiatric contraindication or clinically significant abnormality that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response.\n* Any significant brain MRI abnormality.\n* Use of any investigational drugs or devices, other than bapineuzumab within the last 60 days prior to screening"}, 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