Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-28 @ 4:55 AM
Study NCT ID:
NCT00930059
Status:
COMPLETED
Last Update Posted:
2020-11-19
First Post:
2009-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Of PF-04447943 Compared To Placebo In Subjects With Mild To Moderate Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C572323', 'term': '6-(4-methyl-1-(pyrimidin-2-ylmethyl)pyrrolidin-3-yl)-1-(tetrahydro-2H-pyran-4-yl)-1,5-dihydro-4H-pyrazolo(3,4-d)pyrimidin-4-one'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one 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', 'description': 'Placebo matched to PF-04447943 tablet orally twice daily for 12 weeks.', 'otherNumAtRisk': 100, 'otherNumAffected': 56, 'seriousNumAtRisk': 100, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'PF-04447943', 'description': 'PF-04447943 25 milligram (mg) tablet orally twice daily for 12 weeks.', 'otherNumAtRisk': 91, 'otherNumAffected': 57, 'seriousNumAtRisk': 91, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Bundle branch block right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Eyelid irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Asymptomatic bacteriuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Bacteriuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Labyrinthitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Joint sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Stab wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Blood pressure decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Blood sodium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Carotid bruit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'White blood cell count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Glucose tolerance impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Seborrhoeic keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Thyroid neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Poor quality sleep', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Abnormal behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Eating disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Initial insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Nightmare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Glycosuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Pyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Sputum discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Rosacea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Right Knee Sore', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}], 'seriousEvents': [{'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Chronic hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Traumatic brain injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Cerebral haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) Score at Baseline", 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-04447943 tablet orally twice daily for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-04447943', 'description': 'PF-04447943 25 milligram (mg) tablet orally twice daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.87', 'spread': '10.42', 'groupId': 'OG000'}, {'value': '22.66', 'spread': '10.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1)', 'description': "ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's disease. It comprises of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). Total ADAS-cog 70 score was sum of all items and ranged from 0 (least impairment) to 70 (most severe impairment), higher score indicating worse cognition.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who consumed at least 1 dose of randomized study medication.'}, {'type': 'PRIMARY', 'title': "Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 12", 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-04447943 tablet orally twice daily for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-04447943', 'description': 'PF-04447943 25 milligram (mg) tablet orally twice daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.60', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '-1.91', 'spread': '0.54', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3353', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.31', 'ciLowerLimit': '-1.52', 'ciUpperLimit': '0.90', 'pValueComment': 'The primary test of significance was 1-sided, and a nominal Type I error rate a = 0.05 was employed.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.73', 'groupDescription': 'Least squares (LS) mean difference and p-values were based on analysis of covariance (ANCOVA) on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': "ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's disease. It comprises of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). Total ADAS-cog 70 score was sum of all items and ranged from 0 (least impairment) to 70 (most severe impairment), higher score indicating worse cognition.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who consumed at least 1 dose of randomized study medication. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 3, 6 and 9", 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-04447943 tablet orally twice daily for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-04447943', 'description': 'PF-04447943 25 milligram (mg) tablet orally twice daily for 12 weeks.'}], 'classes': [{'title': 'Change at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.36', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '-1.16', 'spread': '0.52', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.17', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '-1.53', 'spread': '0.53', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.05', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '-2.68', 'spread': '0.53', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6073', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.20', 'ciLowerLimit': '-0.99', 'ciUpperLimit': '1.38', 'pValueComment': 'No adjustments made for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.72', 'groupDescription': 'Change at Week 3: LS mean difference and p-values were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3086', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.36', 'ciLowerLimit': '-1.56', 'ciUpperLimit': '0.84', 'pValueComment': 'No adjustments made for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.73', 'groupDescription': 'Change at Week 6: LS mean difference and p-values were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1970', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.62', 'ciLowerLimit': '-1.82', 'ciUpperLimit': '0.58', 'pValueComment': 'No adjustments made for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.73', 'groupDescription': 'Change at Week 9: LS mean difference and p-values were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 3, 6, 9', 'description': "ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's disease. It comprises of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). Total ADAS-cog 70 score was sum of all items and ranged from 0 (least impairment) to 70 (most severe impairment), higher score indicating worse cognition.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who consumed at least 1 dose of randomized study medication. "Number analyzed" signifies those participants who were evaluable for this measure at the specified time points for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression - Improvement (CGI-I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-04447943 tablet orally twice daily for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-04447943', 'description': 'PF-04447943 25 milligram (mg) tablet orally twice daily for 12 weeks.'}], 'classes': [{'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.64', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '3.70', 'spread': '0.10', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.51', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '3.58', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.63', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '3.45', 'spread': '0.11', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.53', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '3.32', 'spread': '0.11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6547', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.06', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.29', 'pValueComment': 'No adjustments made for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'groupDescription': 'Week 3: Inferential statistics were based on linear model with fixed effects for visit (nominal scale) and visit by treatment interaction, and a random effect for participant.', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7020', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.08', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.31', 'pValueComment': 'No adjustments made for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'groupDescription': 'Week 6: Inferential statistics were based on linear model with fixed effects for visit (nominal scale) and visit by treatment interaction, and a random effect for participant.', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1138', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.17', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '0.06', 'pValueComment': 'No adjustments made for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'groupDescription': 'Week 9: Inferential statistics were based on linear model with fixed effects for visit (nominal scale) and visit by treatment interaction, and a random effect for participant.', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0816', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.20', 'ciLowerLimit': '-0.44', 'ciUpperLimit': '0.04', 'pValueComment': 'No adjustments made for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.15', 'groupDescription': 'Week 12: Inferential statistics were based on linear model with fixed effects for visit (nominal scale) and visit by treatment interaction, and a random effect for participant.', 'statisticalMethod': 'Linear model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 3, 6, 9, 12', 'description': 'CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who consumed at least 1 dose of randomized study medication. "Number Analyzed" signifies those participants who were evaluable for this measure at the specified time points for each arm, respectively.'}, {'type': 'SECONDARY', 'title': 'Neuropsychiatric Inventory (NPI) Total Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-04447943 tablet orally twice daily for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-04447943', 'description': 'PF-04447943 25 milligram (mg) tablet orally twice daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.16', 'spread': '12.86', 'groupId': 'OG000'}, {'value': '10.67', 'spread': '11.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'NPI total score evaluates disturbances in 12 behavioral domains: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating and night time behavior. NPI total score ranged from 0 (minimum severity) to 144 (maximum severity); higher score indicates greater behavioral disturbances.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who consumed at least 1 dose of randomized study medication.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Week 3, 6, 9 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-04447943 tablet orally twice daily for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-04447943', 'description': 'PF-04447943 25 milligram (mg) tablet orally twice daily for 12 weeks.'}], 'classes': [{'title': 'Change at Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.02', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '-1.33', 'spread': '0.70', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.61', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '-1.76', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.44', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '-2.49', 'spread': '0.72', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.70', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '-2.86', 'spread': '0.72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7634', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.69', 'ciLowerLimit': '-0.89', 'ciUpperLimit': '2.27', 'pValueComment': 'No adjustments have been made for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.96', 'groupDescription': 'Change at Week 3: LS mean difference and p-value were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8077', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.85', 'ciLowerLimit': '-0.75', 'ciUpperLimit': '2.45', 'pValueComment': 'No adjustments made for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.97', 'groupDescription': 'Change at Week 6: LS mean difference and p-value were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8350', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.96', 'ciLowerLimit': '-0.66', 'ciUpperLimit': '2.57', 'pValueComment': 'No adjustments made for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.98', 'groupDescription': 'Change at Week 9: LS mean difference and p-value were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4377', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.16', 'ciLowerLimit': '-1.78', 'ciUpperLimit': '1.48', 'pValueComment': 'No adjustments made for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.99', 'groupDescription': 'Change at Week 12: LS mean difference and p-value were based on ANCOVA on change from baseline with treatment, baseline value, scheduled visit and visit by treatment interaction as covariates, and participant effect as random effect.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 3, 6, 9, 12', 'description': 'NPI total score evaluates disturbances in 12 behavioral domains: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating and night time behavior. NPI total score ranged from 0 (minimum severity) to 144 (maximum severity); higher score indicates greater behavioral disturbances.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who consumed at least 1 dose of randomized study medication. "Number Analyzed" signifies those participants who were evaluable for this measure at the specified time points for each arm, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Laboratory Test Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-04447943 tablet orally twice daily for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-04447943', 'description': 'PF-04447943 25 milligram (mg) tablet orally twice daily for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 12', 'description': 'Criteria for laboratory test abnormality: a) Hematology: white blood cells (WBC) \\<0.6\\*lower limit of normal (LLN)/\\>1.5\\*upper limit of normal (ULN), hemoglobin, hematocrit, red blood cells (RBC), lymphocytes \\<0.8\\*LLN, total neutrophils \\<0.8\\*LLN/ \\>1.2\\*ULN, basophils, eosinophils, monocytes \\>1.2\\*ULN; b) Liver Function: total bilirubin \\>1.5\\*ULN, aspartate aminotransferase (AT), alanine AT\\[\\>0.3\\*ULN, total protein, albumin \\<0.8\\*LLN/ \\>1.2\\*ULN; c) Renal Function: creatinine \\>1.3\\*ULN, uric acid \\>1.2\\*ULN; d) Electrolytes: sodium \\<0.95\\*LLN/ \\>1.05\\*ULN, potassium, chloride, bicarbonate \\<0.9\\*LLN/ \\>1.1\\*ULN; e) Clinical Chemistry: glucose \\<0.6\\*LLN/ \\>1.5\\*ULN, glycosylated hemoglobin \\>1.3\\*ULN; f) Urinalysis: ketones, protein, blood/hemoglobin, urine glucose \\>=1, RBC, WBC \\>=6, hyaline casts \\>1; g) Hormones: tetraiodothyronine (T4), triiodothyronine (T3) and thyroid stimulating hormone (TSH) \\<0.8\\*LLN/1.2\\*ULN.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who consumed at least 1 dose of the investigational or control drug. Here, "Overall Number of Participants Analyzed" signifies number of participants who were evaluable for this outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Pre-defined Criteria for Electrocardiogram (ECG) Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-04447943 tablet orally twice daily for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-04447943', 'description': 'PF-04447943 25 milligram (mg) tablet orally twice daily for 12 weeks.'}], 'classes': [{'title': 'PR interval >=300 msec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'PR interval: 25% or 50% increase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'QRS complex >=200 msec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'QRS interval: >=25% or 50% increase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'QT interval >=500 msec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'QTcB interval: 450 to < 480 msec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'QTcB interval: 480 to < 500 msec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'QTcB interval >= 500 msec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'QTcB interval: 30 to <60 msec increase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'QTcB interval: >=60 msec increase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'QTcF interval: 450 to <480 msec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'QTcF interval: 480 to <500 msec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'QTcF Interval >= 500 msec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'QTcF interval: 30 to <60 msec increase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'QTcF interval: >=60 msec increase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 12', 'description': "Criteria for ECG (12-lead) abnormalities were as follow: 1) PR interval: greater than and equal to (\\>=) 300 milliseconds (msec), 2) PR interval: maximum increase from baseline \\>=25 percent (%) (if baseline PR interval greater than \\[\\>\\] 100 msec) or \\>=50% (if baseline PR interval less than or equal to \\[\\<=\\] 100 msec); 3) QRS complex: \\>=200 msec, 4) QRS complex: maximum increase from baseline \\>=25% or \\>=50%; 5) QT interval \\>=500 msec; 6) QT interval corrected using Bazett's formula (QTcB): 450 to less than (\\<) 480 msec, 7) QTcB: 480 to \\<500 msec, 8) QTcB: \\>=500 msec, 10) QTcB: 30 to \\<60 msec increase from baseline, 11) QTcB: \\>=60 msec increase from baseline; 9) QT interval corrected using the Fridericia's formula (QTcF): 450 to \\<480 msec, 10) QTcF: 480 to \\< 500 msec, 11) QTcF: \\>=500 msec, 12) QTcF: 30 to \\<60 msec increase from baseline, 13) QTcF: change\\>=60 msec increase from baseline.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who consumed at least 1 dose of the investigational or control drug. Here, "Number Analyzed" signifies those participants who were evaluable for specified rows for each arm, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Abnormal Physical Examinations and Neurological Examinations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-04447943 tablet orally twice daily for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-04447943', 'description': 'PF-04447943 25 milligram (mg) tablet orally twice daily for 12 weeks.'}], 'classes': [{'title': 'Abdomen: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Abdomen: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Ears: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Ears: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Extremities: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Extremities: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Eyes: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Eyes: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'General: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'General: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Head: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Head: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Heart: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Heart: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Lungs: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lungs: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymph nodes: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymph nodes: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Mouth: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Mouth: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Musculoskeletal: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Musculoskeletal: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Neck: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Neck: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nose: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Nose: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Ocular fundi: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Ocular fundi: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pulses: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Pulses: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Skin: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Skin: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Throat: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Throat: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Thyroid: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Thyroid: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Other: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Other: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening (28 days before Baseline), Week 12', 'description': 'The complete physical and neurological examination included examination of abdomen, ears, extremities, eyes, general, head, heart, lungs, lymph nodes, mouth, musculoskeletal, neck, nose, ocular fundi, pulse, skin, throat, thyroid, and others. Abnormality was judged by investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who consumed at least 1 dose of the investigational or control drug. Here, "Number Analyzed" signifies those participants who were evaluable for specified rows for each arm, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-04447943 tablet orally twice daily for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-04447943', 'description': 'PF-04447943 25 milligram (mg) tablet orally twice daily for 12 weeks.'}], 'classes': [{'title': 'Suicidal behavior: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Suicide attempt: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Interrupted attempt: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Aborted attempt: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Imminent suicidal behavior: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Suicidal ideation: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Non-suicidal SIB: Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Suicidal behavior: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Suicide attempt: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Interrupted Attempt: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Aborted attempt: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Imminent suicidal behavior: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Suicidal ideation: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Non-Suicidal SIB: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Suicidal behavior: Post baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Suicide attempt: Post baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Interrupted attempt: Post baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Aborted attempt: Post baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Imminent suicidal behavior:Post baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Suicidal ideation: Post baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Non-suicidal SIB: Post baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening, Baseline, Post-baseline (Week 1 up to 12)', 'description': 'C-SSRS assessed whether participant experienced the following: suicidal behavior which includes suicide attempt, interrupted attempt, aborted attempt, and preparatory acts towards imminent suicidal behavior (response of "Yes" on "preparatory acts or behavior"); suicidal ideation (response of "Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent); self-injurious behavior (SIB), intent unknown (response of "Yes" on "Has subject engaged in Non-suicidal Self-Injurious Behavior?").', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who consumed at least 1 dose of the investigational or control drug. Here, "Number Analyzed" signifies those participants who were evaluable for specified rows for each arm, respectively.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'PF-04447943 Plasma Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-04447943 tablet orally twice daily for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-04447943', 'description': 'PF-04447943 25 milligram (mg) tablet orally twice daily for 12 weeks.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not estimable as none of the participants had concentration above than lower limit of quantification.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '71.60', 'groupId': 'OG001', 'lowerLimit': '0.000', 'upperLimit': '407'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not estimable as none of the participants had concentration above than lower limit of quantification.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '241.0', 'groupId': 'OG001', 'lowerLimit': '0.000', 'upperLimit': '561'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not estimable as none of the participants had concentration above than lower limit of quantification.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '225.0', 'groupId': 'OG001', 'lowerLimit': '0.000', 'upperLimit': '693'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0000', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '40.6'}, {'value': '239.5', 'groupId': 'OG001', 'lowerLimit': '0.000', 'upperLimit': '738'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not estimable as none of the participants had concentration above than lower limit of quantification.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '250.5', 'groupId': 'OG001', 'lowerLimit': '0.000', 'upperLimit': '598'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose on Week 1; 0 to 3 hours following cognitive testing at Week 3, 6, 9, 12', 'unitOfMeasure': 'nanogram per milliliter', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all the participants who consumed at least 1 dose of randomized study medication. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this measure and "Number Analyzed" signifies those participants who were evaluable for this measure at the specified time points.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Pre-defined Criteria of Vital Signs Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-04447943 tablet orally twice daily for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-04447943', 'description': 'PF-04447943 25 milligram (mg) tablet orally twice daily for 12 weeks.'}], 'classes': [{'title': 'Increase in supine SBP (>=30 mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Decrease in supine SBP (>=30 mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Increase in standing SBP (>=30 mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Decrease in Standing SBP (>=30 mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Increase in supine DBP (>=20 mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Decrease in Supine DBP (>=20 mmHg) (', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Increase in standing DBP(>=20 mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Decrease in Standing DBP(>=20 mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Orthostatic Hypotension: Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Orthostatic Hypotension: Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Orthostatic Hypotension: Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Orthostatic Hypotension: Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Orthostatic Hypotension: Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 12 for change in supine or standing blood pressure; Week 1, 3, 6, 9, 12 for orthostatic hypotension', 'description': 'Pre-defined criteria vital signs abnormalities included maximum increase or decrease of greater than or equal to (\\>=) 30 millimeters of mercury (mmHg) from baseline for supine systolic blood pressure (SBP); maximum increase or decrease of \\>=20 mmHg from baseline for supine diastolic BP (DBP); maximum increase or decrease of \\>=30 mmHg from baseline for standing SBP; maximum increase or decrease of \\>=20 mmHg from baseline for standing DBP. Orthostatic hypotension was defined as a drop of more than 10 mmHg in diastolic BP or a drop of more than 20 mmHg in systolic BP within 3 minutes of standing from the supine position.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who consumed at least 1 dose of the investigational or control drug. "Number Analyzed" signifies those participants who were evaluable for the specified rows for each arm, respectively.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-04447943 tablet orally twice daily for 12 weeks.'}, {'id': 'FG001', 'title': 'PF-04447943', 'description': 'PF-04447943 25 milligram (mg) tablet orally twice daily for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '91'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '79'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Did not meet entrance criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': '1 site terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo matched to PF-04447943 tablet orally twice daily for 12 weeks.'}, {'id': 'BG001', 'title': 'PF-04447943', 'description': 'PF-04447943 25 milligram (mg) tablet orally twice daily for 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.5', 'spread': '7.5', 'groupId': 'BG000'}, {'value': '73.6', 'spread': '8.2', 'groupId': 'BG001'}, {'value': '73.5', 'spread': '7.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS) included all participants who consumed at least 1 dose of randomized study medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 191}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'dispFirstSubmitDate': '2013-04-09', 'completionDateStruct': {'date': '2010-09-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-28', 'studyFirstSubmitDate': '2009-06-29', 'dispFirstSubmitQcDate': '2013-04-09', 'resultsFirstSubmitDate': '2020-10-28', 'studyFirstSubmitQcDate': '2009-06-29', 'dispFirstPostDateStruct': {'date': '2013-04-16', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-28', 'studyFirstPostDateStruct': {'date': '2009-06-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-09-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Laboratory Test Abnormalities', 'timeFrame': 'Baseline up to Week 12', 'description': 'Criteria for laboratory test abnormality: a) Hematology: white blood cells (WBC) \\<0.6\\*lower limit of normal (LLN)/\\>1.5\\*upper limit of normal (ULN), hemoglobin, hematocrit, red blood cells (RBC), lymphocytes \\<0.8\\*LLN, total neutrophils \\<0.8\\*LLN/ \\>1.2\\*ULN, basophils, eosinophils, monocytes \\>1.2\\*ULN; b) Liver Function: total bilirubin \\>1.5\\*ULN, aspartate aminotransferase (AT), alanine AT\\[\\>0.3\\*ULN, total protein, albumin \\<0.8\\*LLN/ \\>1.2\\*ULN; c) Renal Function: creatinine \\>1.3\\*ULN, uric acid \\>1.2\\*ULN; d) Electrolytes: sodium \\<0.95\\*LLN/ \\>1.05\\*ULN, potassium, chloride, bicarbonate \\<0.9\\*LLN/ \\>1.1\\*ULN; e) Clinical Chemistry: glucose \\<0.6\\*LLN/ \\>1.5\\*ULN, glycosylated hemoglobin \\>1.3\\*ULN; f) Urinalysis: ketones, protein, blood/hemoglobin, urine glucose \\>=1, RBC, WBC \\>=6, hyaline casts \\>1; g) Hormones: tetraiodothyronine (T4), triiodothyronine (T3) and thyroid stimulating hormone (TSH) \\<0.8\\*LLN/1.2\\*ULN.'}, {'measure': 'Number of Participants With Pre-defined Criteria for Electrocardiogram (ECG) Abnormalities', 'timeFrame': 'Baseline up to Week 12', 'description': "Criteria for ECG (12-lead) abnormalities were as follow: 1) PR interval: greater than and equal to (\\>=) 300 milliseconds (msec), 2) PR interval: maximum increase from baseline \\>=25 percent (%) (if baseline PR interval greater than \\[\\>\\] 100 msec) or \\>=50% (if baseline PR interval less than or equal to \\[\\<=\\] 100 msec); 3) QRS complex: \\>=200 msec, 4) QRS complex: maximum increase from baseline \\>=25% or \\>=50%; 5) QT interval \\>=500 msec; 6) QT interval corrected using Bazett's formula (QTcB): 450 to less than (\\<) 480 msec, 7) QTcB: 480 to \\<500 msec, 8) QTcB: \\>=500 msec, 10) QTcB: 30 to \\<60 msec increase from baseline, 11) QTcB: \\>=60 msec increase from baseline; 9) QT interval corrected using the Fridericia's formula (QTcF): 450 to \\<480 msec, 10) QTcF: 480 to \\< 500 msec, 11) QTcF: \\>=500 msec, 12) QTcF: 30 to \\<60 msec increase from baseline, 13) QTcF: change\\>=60 msec increase from baseline."}, {'measure': 'Number of Participants With Abnormal Physical Examinations and Neurological Examinations', 'timeFrame': 'Screening (28 days before Baseline), Week 12', 'description': 'The complete physical and neurological examination included examination of abdomen, ears, extremities, eyes, general, head, heart, lungs, lymph nodes, mouth, musculoskeletal, neck, nose, ocular fundi, pulse, skin, throat, thyroid, and others. Abnormality was judged by investigator.'}, {'measure': 'Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'Screening, Baseline, Post-baseline (Week 1 up to 12)', 'description': 'C-SSRS assessed whether participant experienced the following: suicidal behavior which includes suicide attempt, interrupted attempt, aborted attempt, and preparatory acts towards imminent suicidal behavior (response of "Yes" on "preparatory acts or behavior"); suicidal ideation (response of "Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent); self-injurious behavior (SIB), intent unknown (response of "Yes" on "Has subject engaged in Non-suicidal Self-Injurious Behavior?").'}, {'measure': 'PF-04447943 Plasma Concentration', 'timeFrame': 'Pre-dose on Week 1; 0 to 3 hours following cognitive testing at Week 3, 6, 9, 12'}, {'measure': 'Number of Participants With Pre-defined Criteria of Vital Signs Abnormalities', 'timeFrame': 'Baseline up to Week 12 for change in supine or standing blood pressure; Week 1, 3, 6, 9, 12 for orthostatic hypotension', 'description': 'Pre-defined criteria vital signs abnormalities included maximum increase or decrease of greater than or equal to (\\>=) 30 millimeters of mercury (mmHg) from baseline for supine systolic blood pressure (SBP); maximum increase or decrease of \\>=20 mmHg from baseline for supine diastolic BP (DBP); maximum increase or decrease of \\>=30 mmHg from baseline for standing SBP; maximum increase or decrease of \\>=20 mmHg from baseline for standing DBP. Orthostatic hypotension was defined as a drop of more than 10 mmHg in diastolic BP or a drop of more than 20 mmHg in systolic BP within 3 minutes of standing from the supine position.'}], 'primaryOutcomes': [{'measure': "Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) Score at Baseline", 'timeFrame': 'Baseline (Day 1)', 'description': "ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's disease. It comprises of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). Total ADAS-cog 70 score was sum of all items and ranged from 0 (least impairment) to 70 (most severe impairment), higher score indicating worse cognition."}, {'measure': "Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 12", 'timeFrame': 'Baseline, Week 12', 'description': "ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's disease. It comprises of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). Total ADAS-cog 70 score was sum of all items and ranged from 0 (least impairment) to 70 (most severe impairment), higher score indicating worse cognition."}], 'secondaryOutcomes': [{'measure': "Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 3, 6 and 9", 'timeFrame': 'Baseline, Week 3, 6, 9', 'description': "ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's disease. It comprises of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). Total ADAS-cog 70 score was sum of all items and ranged from 0 (least impairment) to 70 (most severe impairment), higher score indicating worse cognition."}, {'measure': 'Clinical Global Impression - Improvement (CGI-I)', 'timeFrame': 'Week 3, 6, 9, 12', 'description': 'CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.'}, {'measure': 'Neuropsychiatric Inventory (NPI) Total Score at Baseline', 'timeFrame': 'Baseline', 'description': 'NPI total score evaluates disturbances in 12 behavioral domains: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating and night time behavior. NPI total score ranged from 0 (minimum severity) to 144 (maximum severity); higher score indicates greater behavioral disturbances.'}, {'measure': 'Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Week 3, 6, 9 and 12', 'timeFrame': 'Baseline, Week 3, 6, 9, 12', 'description': 'NPI total score evaluates disturbances in 12 behavioral domains: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating and night time behavior. NPI total score ranged from 0 (minimum severity) to 144 (maximum severity); higher score indicates greater behavioral disturbances.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Alzheimer's disease", 'PF-04447943', 'efficacy', 'safety', 'plasma concentrations'], 'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0401005&StudyName=A%20Study%20Of%20PF-04447943%20Compared%20To%20Placebo%20In%20Subjects%20With%20Mild%20To%20Moderate%20Alzheimer%27s%20Disease', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the effects of PF-04447943 compared to placebo on cognitive, behavioral and overall symptoms of Alzheimer's disease; evaluate the safety and tolerability of PF-0444793 compared to placebo; and determine the levels of PF-04447943 in the plasma over the course of the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Mild to moderate Alzheimer's disease (MMSE 14-26)\n* Good general health (such controlled conditions as Type 2 diabetes and hypertension allowed)\n\nExclusion Criteria:\n\n* Use of acetylcholinesterase inhibitors (donepezil, rivastigmine, or galantamine) or memantine within 12 weeks of the start of the study\n* Significant cardiovascular disease in the past 6 months\n* Illness other than Alzheimer's disease that could contribute to cognitive impairment\n* History of stroke or seizure disorder"}, 'identificationModule': {'nctId': 'NCT00930059', 'briefTitle': "A Study Of PF-04447943 Compared To Placebo In Subjects With Mild To Moderate Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': "A PHASE 2 MULTICENTER, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY OF PF-04447943 IN SUBJECTS WITH MILD TO MODERATE ALZHEIMER'S DISEASE", 'orgStudyIdInfo': {'id': 'B0401005'}, 'secondaryIdInfos': [{'id': '2009-012179-82', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-04447943', 'interventionNames': ['Drug: PF-04447943']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'PF-04447943', 'type': 'DRUG', 'description': 'tablets, 25 mg every 12 hours for 12 wks', 'armGroupLabels': ['PF-04447943']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'matching placebo tablets, every 12 hours for 12 wks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35476', 'city': 'Northport', 'state': 'Alabama', 'country': 'United States', 'facility': 'Neurology Clinic, PC', 'geoPoint': {'lat': 33.22901, 'lon': -87.57723}}, {'zip': '92626', 'city': 'Costa Mesa', 'state': 'California', 'country': 'United States', 'facility': 'ATP Clinical Research, Inc.', 'geoPoint': {'lat': 33.64113, 'lon': -117.91867}}, {'zip': '91204', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Southwestern Research Incorporated', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Coast Imaging (for Imaging only)', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '92270', 'city': 'Rancho Mirage', 'state': 'California', 'country': 'United States', 'facility': 'The Southwest Institute for Clinical Research, Inc.', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'zip': '92128', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Research Network (Satellite Site)', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92081', 'city': 'Vista', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Research Network, Inc. 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