Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-26 @ 1:39 AM
Study NCT ID:
NCT01208233
Status:
TERMINATED
Last Update Posted:
2016-02-19
First Post:
2010-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study Evaluating The Safety And Efficacy Of PF-03049423 In Subjects With Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Mexico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C549061', 'term': '3-(4-(2-hydroxyethyl)piperazin-1-yl)-7-(6-methoxypyridin-3-yl)-1-(2-propoxyethyl)pyrido(3,4-b)pyrazin-2(1H)-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}, 'limitationsAndCaveats': {'description': 'The study was terminated prematurely due to demonstrated futility at interim analysis. The final results are consistent with interim results.'}}, 'adverseEventsModule': {'timeFrame': 'From the time the subject had taken at least 1 dose of study treatment through last subject visit. For SAEs, the time began from the subject provided informed consent through 28 calendar days post last administration of investigational product.', 'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1: PF-03049423 1 mg', 'description': 'Participants received PF-03049423 1 mg once daily for 90 days.', 'otherNumAtRisk': 11, 'otherNumAffected': 10, 'seriousNumAtRisk': 11, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Cohort 1: Placebo', 'description': 'Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.', 'otherNumAtRisk': 9, 'otherNumAffected': 7, 'seriousNumAtRisk': 9, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Cohort 2: PF-03049423 3 mg', 'description': 'Participants received PF-03049423 3 mg once daily for 90 days.', 'otherNumAtRisk': 11, 'otherNumAffected': 7, 'seriousNumAtRisk': 11, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Cohort 2: Placebo', 'description': 'Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.', 'otherNumAtRisk': 10, 'otherNumAffected': 9, 'seriousNumAtRisk': 10, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.', 'otherNumAtRisk': 70, 'otherNumAffected': 50, 'seriousNumAtRisk': 70, 'seriousNumAffected': 15}, {'id': 'EG005', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.', 'otherNumAtRisk': 67, 'otherNumAffected': 47, 'seriousNumAtRisk': 67, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Neutrophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Supraventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Atrial septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 2}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Conjunctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Eye disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 9}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Genitourinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 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'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Ischaemic cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Disorientation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Asphyxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Any Abnormal Laboratory Test Results (Part 1* and 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '66', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: PF-03049423 1 mg', 'description': 'Participants received PF-03049423 1 mg once daily for 90 days.'}, {'id': 'OG001', 'title': 'Cohort 1: Placebo', 'description': 'Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.'}, {'id': 'OG002', 'title': 'Cohort 2: PF-03049423 3 mg', 'description': 'Participants received PF-03049423 3 mg once daily for 90 days.'}, {'id': 'OG003', 'title': 'Cohort 2: Placebo', 'description': 'Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.'}, {'id': 'OG004', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}, {'id': 'OG005', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '64', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Baseline) up to Day 90', 'description': 'The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. \\*This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all randomized participants who took any study medication (active or placebo). Participants analyzed indicated number of participants evaluated.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern (Part 1* and 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '67', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: PF-03049423 1 mg', 'description': 'Participants received PF-03049423 1 mg once daily for 90 days.'}, {'id': 'OG001', 'title': 'Cohort 1: Placebo', 'description': 'Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.'}, {'id': 'OG002', 'title': 'Cohort 2: PF-03049423 3 mg', 'description': 'Participants received PF-03049423 3 mg once daily for 90 days.'}, {'id': 'OG003', 'title': 'Cohort 2: Placebo', 'description': 'Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.'}, {'id': 'OG004', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}, {'id': 'OG005', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.'}], 'classes': [{'title': 'Supine SBP <90 mm Hg, n=11,9,11,10,70,67', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Sitting SBP <90 mm Hg, n=10,8,9,5,55,59', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Standing SBP <90 mm Hg, n=7,7,9,8,49,48', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Supine DBP <50 mm Hg, n=11,9,11,10,70,67', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'title': 'Sitting DBP <50 mm Hg, n=10,8,9,5,55,59', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Standing DBP <50 mm Hg, n=7,7,9,8,49,48', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'Supine pulse rate <40 bpm, n=11,9,11,10,70,67', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Supine pulse rate >120 bpm, n=11,9,11,10,70,67', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}]}, {'title': 'Increase:supine SBP >=30 mm Hg, n=11,9,11,10,70,67', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}]}]}, {'title': 'Increase: sitting SBP >=30 mm Hg, n=9,6,9,4,48,44', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}]}, {'title': 'Increase: standing SBP >=30 mm Hg, n=2,3,3,6,19,22', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Increase:supine DBP >=20 mm Hg, n=11,9,11,10,70,67', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}]}, {'title': 'Increase: sitting DBP >=20 mm Hg, n=9,6,9,4,48,44', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}]}]}, {'title': 'Increase: standing DBP >=20 mm Hg, n=2,3,3,6,19,22', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'Decrease:supine SBP >=30 mm Hg, n=11,9,11,10,70,67', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}, {'value': '37', 'groupId': 'OG005'}]}]}, {'title': 'Decrease: sitting SBP >=30 mm Hg, n=9,6,9,4,48,44', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}]}, {'title': 'Decrease: standing SBP >=30 mm Hg, n=2,3,3,6,19,22', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}]}, {'title': 'Decrease:supine DBP >=20 mm Hg, n=11,9,11,10,70,67', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}]}, {'title': 'Decrease: sitting DBP >=20 mm Hg, n=9,6,9,4,48,44', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}]}, {'title': 'Decrease: standing DBP >=20 mm Hg, n=2,3,3,6,19,22', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}]}, {'title': 'Decrease:supine SBP >=50 mm Hg, n=11,9,11,10,70,67', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}]}, {'title': 'Decrease: sitting SBP >=50 mm Hg, n=9,6,9,4,48,44', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}]}, {'title': 'Decrease: standing SBP >=50 mm Hg, n=2,3,3,6,19,22', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Sitting pulse rate <40 bpm, n=1,0,2,0,3,2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No participants were evaluated.', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No participants were evaluated', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Standing pulse rate <40 bpm, n=0,0,0,2,1,0', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No participants were evaluated.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No participants were evaluated.', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'No participants were evaluated.', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'No participants were evaluated.', 'groupId': 'OG005'}]}]}, {'title': 'Sitting pulse rate >120 bpm, n=1,0,2,0,3,2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No participants were evaluated.', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No participants were evaluated.', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Standing pulse rate >140 bpm, n=0,0,0,2,1,0', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No participants were evaluated.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No participants were evaluated.', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'No participants were evaluated.', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'No participants were evaluated.', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Baseline) up to follow-up (28 days after Day 90)', 'description': 'Vital signs included blood pressure (BP; supine, sitting and standing) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic BP (SBP) greater than or equal to (\\>=) 30 or 50 millimeters of mercury (mm Hg) change from grand baseline in same posture, systolic less than (\\<) 90 mm Hg; diastolic BP (DBP) \\>=20 mm Hg change from grand baseline in same posture, diastolic \\<50 mm Hg; 2), pulse rate (supine, sitting and standing): \\<40 or greater than (\\>) 120 beats per minute (bpm); Standing: \\<40 or \\>140 bpm. \\*This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all randomized participants who took any study medication (active or placebo). n=number of evaluable participants.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Electrocardiograms (ECGs) Data Met Criteria of Potential Clinical Concern (Part 1* and 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '67', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: PF-03049423 1 mg', 'description': 'Participants received PF-03049423 1 mg once daily for 90 days.'}, {'id': 'OG001', 'title': 'Cohort 1: Placebo', 'description': 'Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.'}, {'id': 'OG002', 'title': 'Cohort 2: PF-03049423 3 mg', 'description': 'Participants received PF-03049423 3 mg once daily for 90 days.'}, {'id': 'OG003', 'title': 'Cohort 2: Placebo', 'description': 'Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.'}, {'id': 'OG004', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}, {'id': 'OG005', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.'}], 'classes': [{'title': 'PR interval >=300 msec, n=11,9,11,10,70,67', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'QRS interval >=140 msec, n=11,9,11,10,70,67', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'QT interval >=500 msec, n=11,9,11,10,70,67', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'QTcF interval 450-480 msec, n=11,9,11,10,70,67', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}]}, {'title': 'QTcF interval 480-500 msec, n=11,9,11,10,70,67', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}]}]}, {'title': 'QTcF interval >=500 msec, n=11,9,11,10,70,67', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'PR interval increase >=25%/50%, n=10,7,9,9,52,47', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'QRS interval increase >=50%, n=10,9,11,10,69,66', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'QTcF increase 30-60 msec, n=10,9,11,10,69,66', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}]}, {'title': 'QTcF increase >=60 msec, n=10,9,11,10,69,66', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Baseline) to Day 90', 'description': "ECG criteria of potential clinical concern were 1), PR interval: \\>=300 milliseconds (msec); \\>=25% increase when baseline \\>200 msec; or increase \\>=50% when baseline \\<=200 msec; 2), QRS interval: \\>=140 msec; \\>=50% increase from baseline; 3), QT interval: \\>=500 msec, QTc interval using Fridericia's formula (QTcF interval): absolute value \\>=450 - \\<480 msec, \\>=480-\\<500 msec, \\>=500 msec; absolute change 30 - \\<60, \\>=60 msec. \\*This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all randomized participants who took any study medication (active or placebo). n=number of evaluable participants.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Significant Change in Physical Examination Findings (Part 1* and 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '66', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: PF-03049423 1 mg', 'description': 'Participants received PF-03049423 1 mg once daily for 90 days.'}, {'id': 'OG001', 'title': 'Cohort 1: Placebo', 'description': 'Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.'}, {'id': 'OG002', 'title': 'Cohort 2: PF-03049423 3 mg', 'description': 'Participants received PF-03049423 3 mg once daily for 90 days.'}, {'id': 'OG003', 'title': 'Cohort 2: Placebo', 'description': 'Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.'}, {'id': 'OG004', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}, {'id': 'OG005', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Baseline) up to Day 90', 'description': 'The complete physical examination included examination of the skin, eyes, ears, throat, neck, cardiac, respiratory, gastrointestinal, and musculoskeletal systems. The limited physical examination included examination of the cardiac, respiratory, gastrointestinal, and musculoskeletal systems. \\*This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all randomized participants who took any study medication (active or placebo). Participants analyzed indicated those who had physical examinations done at both baseline and last visit.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Significant Change in Neurological Examination Findings (Part 1* and 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '66', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: PF-03049423 1 mg', 'description': 'Participants received PF-03049423 1 mg once daily for 90 days.'}, {'id': 'OG001', 'title': 'Cohort 1: Placebo', 'description': 'Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.'}, {'id': 'OG002', 'title': 'Cohort 2: PF-03049423 3 mg', 'description': 'Participants received PF-03049423 3 mg once daily for 90 days.'}, {'id': 'OG003', 'title': 'Cohort 2: Placebo', 'description': 'Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.'}, {'id': 'OG004', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}, {'id': 'OG005', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Baseline) up to Day 90', 'description': 'The complete neurological examination included an assessment of the motor, sensory, cranial nerves, reflexes, mental status and associated motor functions. The limited neurological exam could examine the same categories of neurologic assessments as the full examination, but would differ by the depth in the examination. The examination was required to be done to the extent needed to assess the participant for any potential changes in neurological status, as determined by the Investigator, but had to always include an assessment of motor, vision and hearing. \\*This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all randomized participants who took any study medication (active or placebo). Participants analyzed indicated those who had neurological examinations done at both baseline and last visit.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Suicidal Behavior and/or Ideation as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) (Part 1* and 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '67', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: PF-03049423 1 mg', 'description': 'Participants received PF-03049423 1 mg once daily for 90 days.'}, {'id': 'OG001', 'title': 'Cohort 1: Placebo', 'description': 'Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.'}, {'id': 'OG002', 'title': 'Cohort 2: PF-03049423 3 mg', 'description': 'Participants received PF-03049423 3 mg once daily for 90 days.'}, {'id': 'OG003', 'title': 'Cohort 2: Placebo', 'description': 'Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.'}, {'id': 'OG004', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}, {'id': 'OG005', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.'}], 'classes': [{'title': 'Day 7, n=0, 0, 1, 1, 64, 57', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No participants had C-SSRS assessed.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No participants had C-SSRS assessed.', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'Day 14, n=0, 0, 1, 1, 59, 53', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No participants had C-SSRS assessed.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No participants had C-SSRS assessed.', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 30, n=0, 0, 1, 1, 60, 47', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No participants had C-SSRS assessed.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No participants had C-SSRS assessed.', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 60, n=0, 0, 1, 1, 55, 44', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No participants had C-SSRS assessed.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No participants had C-SSRS assessed.', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Day 90, n=0, 0, 1, 1, 61, 53', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No participants had C-SSRS assessed.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No participants had C-SSRS assessed.', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Follow-up, n=0, 0, 1, 1, 59, 51', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'No participants had C-SSRS assessed.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No participants had C-SSRS assessed.', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 7 (Baseline) up to follow up (28 days after Day 90)', 'description': 'Data were mapped to Columbia-Classification Algorithm of Suicide Assessment (C-CASA) event codes. C-SSRS assessed if participant experienced: completed suicide (Code 1), suicide attempt (Code 2) (Response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (Code 3) ("Yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"), suicidal ideation (Code 4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Code 7) ("Yes" on "Has participant engaged in non-suicidal self-injurious behavior"). Number of participants with "Yes" response for any of above mentioned categories was assessed. \\*This was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for it were not reported separately, Part 1 and 2 data were reported together.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all randomized participants who took any study medication (active or placebo). n=number of participants who had C-SSRS assessed at that visit.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Modified Rankin Scale (mRS) Less Than or Equal to (<=2) at Day 90 (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}, {'id': 'OG001', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.'}], 'classes': [{'title': 'Last Observation Carried Forward (LOCF), n=68, 65', 'categories': [{'measurements': [{'value': '42.6', 'groupId': 'OG000'}, {'value': '46.2', 'groupId': 'OG001'}]}]}, {'title': 'Observed Cases (OC), n=51, 52', 'categories': [{'measurements': [{'value': '47.1', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4962', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.735', 'ciLowerLimit': '0.41', 'ciUpperLimit': '1.31', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'LOCF was used to impute missing data.', 'testedNonInferiority': False}, {'pValue': '0.2517', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.561', 'ciLowerLimit': '0.29', 'ciUpperLimit': '1.07', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'The analysis was based on OC.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 90', 'description': 'The mRS is a 6-point scale of functional recovery. The scale grades participants as having no symptoms (0), minor symptoms (1), minor handicap (2), moderate handicap (3), moderately severe handicap (4), severe handicap (5), or death (6).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Inferential Full Analysis Set (I-FAS) consisted of participants within the FAS who were randomized to PF-03049423 maximum tolerated dose (MTD) or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). n=number of participants included for comparison between active drug and placebo.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Box and Blocks (B&B) Test at Day 90 for Paretic Hand (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}, {'id': 'OG001', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.881', 'spread': '3.8667', 'groupId': 'OG000'}, {'value': '26.741', 'spread': '3.5627', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9716', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.141', 'ciLowerLimit': '-4.972', 'ciUpperLimit': '5.254', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.9420', 'groupDescription': 'Paretic hand', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (Baseline), Day 90', 'description': 'The B\\&B test is a measure of manual dexterity. The B\\&B apparatus consists of a box divided into 2 sections and 1-inch hardwood blocks. The blocks began in the compartment of the test box to the dominant side of the participant. The participant was required to transfer the blocks one at a time to the other side of the box as quickly as possible in 1 minute using the non-paretic hand. The box was then turned so all the blocks were in the same side as the paretic hand. The participant was then required to do the test with his/her paretic hand. The participant was told that if more than 1 block was picked up at a time it was to only count as 1 block. The participant was also told that their fingertips needed to cross the partition for the block to be counted. The performance measure for this task was the number of blocks moved within 1 minute.', 'unitOfMeasure': 'blocks moved per minute', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Number of participants indicated those participants included for comparison between active drug and placebo.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Box and Blocks (B&B) Test at Day 90 for Paretic to Non-paretic Hand Ratio (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}, {'id': 'OG001', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.830', 'spread': '7.7810', 'groupId': 'OG000'}, {'value': '31.041', 'spread': '7.1284', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1417', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '10.789', 'ciLowerLimit': '1.401', 'ciUpperLimit': '20.177', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.2392', 'groupDescription': 'Paretic to non-paretic hand ratio (%)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (Baseline), Day 90', 'description': 'The B\\&B test is a measure of manual dexterity. The B\\&B apparatus consists of a box divided into 2 sections and 1-inch hardwood blocks. The blocks began in the compartment of the test box to the dominant side of the participant. The participant was required to transfer the blocks one at a time to the other side of the box as quickly as possible in 1 minute using the non-paretic hand. The box was then turned so all the blocks were in the same side as the paretic hand. The participant was then required to do the test with his/her paretic hand. The participant was told that if more than 1 block was picked up at a time it was to only count as 1 block. The participant was also told that their fingertips needed to cross the partition for the block to be counted. The performance measure for this task was the number of blocks moved within 1 minute.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Number of participants indicated those participants included for comparison between active drug and placebo.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hand Grip Strength Test at Day 90 for Paretic and Non-paretic Hands (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}, {'id': 'OG001', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.'}], 'classes': [{'title': 'Paretic Hand, n=26, 26', 'categories': [{'measurements': [{'value': '20.556', 'spread': '4.1829', 'groupId': 'OG000'}, {'value': '30.886', 'spread': '3.9964', 'groupId': 'OG001'}]}]}, {'title': 'Non-Paretic Hand, n=46, 41', 'categories': [{'measurements': [{'value': '12.546', 'spread': '2.3612', 'groupId': 'OG000'}, {'value': '12.312', 'spread': '2.5029', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0611', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-10.330', 'ciLowerLimit': '-17.351', 'ciUpperLimit': '-3.310', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.4241', 'groupDescription': 'Paretic hand', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.9433', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.235', 'ciLowerLimit': '-4.011', 'ciUpperLimit': '4.480', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.2899', 'groupDescription': 'Non-paretic hand', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (Baseline), Day 90', 'description': 'The Hand Grip Strength Test measures the maximum isometric strength of the hand and forearm muscles. The participant was required to squeeze the dynamometer with maximum isometric effort while sitting with shoulder adducted and neutrally roated, elbow flexed at 90 degrees and the forearm in neutral position and wrist between 0 to 30 degrees dorsiflexion and a 0 to 15 degrees ulnar deviation. The participant performed this task 3 times with each hand, starting with the non-paretic hand. The performance measure for this task was the average score measured in pounds of pressure exerted.', 'unitOfMeasure': 'pounds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). n=number of participants included for comparison between active drug and placebo.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hand Grip Strength Test at Day 90 for Paretic to Non-paretic Hand Ratio (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}, {'id': 'OG001', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.949', 'spread': '5.4499', 'groupId': 'OG000'}, {'value': '36.761', 'spread': '5.1182', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0654', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-12.812', 'ciLowerLimit': '-21.668', 'ciUpperLimit': '-3.957', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.8448', 'groupDescription': 'Paretic to non-paretic hand ratio (%)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (Baseline), Day 90', 'description': 'The Hand Grip Strength Test measures the maximum isometric strength of the hand and forearm muscles. The participant was required to squeeze the dynamometer with maximum isometric effort while sitting with shoulder adducted and neutrally roated, elbow flexed at 90 degrees and the forearm in neutral position and wrist between 0 to 30 degrees dorsiflexion and a 0 to 15 degrees ulnar deviation. The participant performed this task 3 times with each hand, starting with the non-paretic hand. The performance measure for this task was the average score measured in pounds of pressure exerted.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Number of participants analyzed indicated those participants included for comparison between active drug and placebo.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With mRS (0-1) at Day 90 (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}, {'id': 'OG001', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '24.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9510', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.972', 'ciLowerLimit': '0.54', 'ciUpperLimit': '1.76', 'groupDescription': 'LOCF was used to impute missing data.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 90', 'description': 'The mRS is a 6-point scale of functional recovery. The scale grades participants as having no symptoms (0), minor symptoms (1), minor handicap (2), moderate handicap (3), moderately severe handicap (4), severe handicap (5), or death (6).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With National Institutes of Health Stroke Scale (NIHSS) (0-1) at Day 90 (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}, {'id': 'OG001', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '26.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7234', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.854', 'ciLowerLimit': '0.48', 'ciUpperLimit': '1.51', 'groupDescription': 'LOCF was used to impute missing data.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 90', 'description': 'The NIHSS is a graded 11-item neurological examination rating speech and language, cognition, visual field deficits, motor and sensory impairments and ataxia used for the clinical assessment of acute stroke therapy. The maximum total score is 42 in a participant with a severe neurological deficit; the minimum score is 0 in a participant without gross neurological deficits.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in NIHSS at Day 90 (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}, {'id': 'OG001', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.511', 'spread': '0.5384', 'groupId': 'OG000'}, {'value': '-6.228', 'spread': '0.5655', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6759', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.283', 'ciLowerLimit': '-1.156', 'ciUpperLimit': '0.589', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.6755', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (Baseline), Day 90', 'description': 'The NIHSS is a graded 11-item neurological examination rating speech and language, cognition, visual field deficits, motor and sensory impairments and ataxia used for the clinical assessment of acute stroke therapy. The maximum total score is 42 in a participant with a severe neurological deficit; the minimum score is 0 in a participant without gross neurological deficits.', 'unitOfMeasure': 'unit on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Participants analyzed indicated number of participants included for comparison between active drug and placebo for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Barthel Index (BI) >= 95 and BI =100 at Day 90 (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}, {'id': 'OG001', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.'}], 'classes': [{'title': 'BI >=95', 'categories': [{'measurements': [{'value': '47.1', 'groupId': 'OG000'}, {'value': '40.0', 'groupId': 'OG001'}]}]}, {'title': 'BI=100', 'categories': [{'measurements': [{'value': '42.6', 'groupId': 'OG000'}, {'value': '35.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4213', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.433', 'ciLowerLimit': '0.81', 'ciUpperLimit': '2.54', 'groupDescription': 'BI \\>=95, LOCF was used to impute missing data.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2760', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.651', 'ciLowerLimit': '0.92', 'ciUpperLimit': '2.98', 'groupDescription': 'BI=100, LOCF was used to impute missing data.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Day 90', 'description': "The BI is an index of independence to score the ability of a participant with a neuromuscular or musculoskeletal disorder to care for him or herself. The index rates a participant's ability on the following 10 activities: feeding, moving from wheelchair to bed, personal toilet, getting on and off toilet, bathing self, walking on level surface, ascending and descending stairs, dressing, controlling bowels and controlling bladder. The maximum total score is 100 in a participant without functional impairment; the minimum score is 0 in a participant with major functional impairment.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg).'}, {'type': 'SECONDARY', 'title': 'BI at Day 90 (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}, {'id': 'OG001', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.151', 'spread': '3.6248', 'groupId': 'OG000'}, {'value': '73.552', 'spread': '3.8471', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2118', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '5.599', 'ciLowerLimit': '-0.150', 'ciUpperLimit': '11.348', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.4547', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 90', 'description': "The BI is an index of independence to score the ability of a participant with a neuromuscular or musculoskeletal disorder to care for him or herself. The index rates a participant's ability on the following 10 activities: feeding, moving from wheelchair to bed, personal toilet, getting on and off toilet, bathing self, walking on level surface, ascending and descending stairs, dressing, controlling bowels and controlling bladder. The maximum total score is 100 in a participant without functional impairment; the minimum score is 0 in a participant with major functional impairment.", 'unitOfMeasure': 'unit on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Participants analyzed indicated number of participants included for comparison between active drug and placebo for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Domains of Interest: Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Coding Sub Test at Day 90 (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}, {'id': 'OG001', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.748', 'spread': '1.5321', 'groupId': 'OG000'}, {'value': '12.686', 'spread': '1.6282', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5541', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.062', 'ciLowerLimit': '-1.252', 'ciUpperLimit': '3.375', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.7844', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (Baseline), Day 90', 'description': 'The test uses a reference key, the participant had 90 seconds to pair specific numbers with given geometric figures. Responses could be written or oral. The performance measure for this task was the total number of correct responses.', 'unitOfMeasure': 'correct responses', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Participants analyzed indicated number of participants included for comparison between active drug and placebo for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Domains of Interest: Change From Baseline in RBANS Naming Sub Test at Day 90 (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}, {'id': 'OG001', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.989', 'spread': '0.3676', 'groupId': 'OG000'}, {'value': '1.324', 'spread': '0.3666', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4260', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.334', 'ciLowerLimit': '-0.874', 'ciUpperLimit': '0.205', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.4178', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (Baseline), Day 90', 'description': 'This test requires the participant to name 10 objects drawn in ink. The tester asked the participant to identify the picture. The participant had 20 seconds to respond to each picture presented. The performance measure was the number of objects named correctly.', 'unitOfMeasure': 'objects named correctly', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Participants analyzed indicated number of participants included for comparison between active drug and placebo for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Domains of Interest: Change From Baseline in Line Cancellation Test [(L+R)/28 × 100%, (L/14) × 100%, (R/14) × 100%)] at Day 90 (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}, {'id': 'OG001', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.'}], 'classes': [{'title': '(L+R)/28 × 100%, n=39, 35', 'categories': [{'measurements': [{'value': '19.459', 'spread': '4.4433', 'groupId': 'OG000'}, {'value': '16.983', 'spread': '4.4551', 'groupId': 'OG001'}]}]}, {'title': '(L/14) × 100%, n=39, 35', 'categories': [{'measurements': [{'value': '22.824', 'spread': '5.6691', 'groupId': 'OG000'}, {'value': '18.950', 'spread': '5.6639', 'groupId': 'OG001'}]}]}, {'title': '(R/14) × 100%, n=39, 35', 'categories': [{'measurements': [{'value': '16.481', 'spread': '4.3564', 'groupId': 'OG000'}, {'value': '15.431', 'spread': '4.3647', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6500', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '2.477', 'ciLowerLimit': '-4.547', 'ciUpperLimit': '9.500', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.4394', 'groupDescription': '(L+R)/28 × 100%', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5671', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '3.874', 'ciLowerLimit': '-4.834', 'ciUpperLimit': '12.583', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.7431', 'groupDescription': '(L/14) × 100%', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.8430', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '1.049', 'ciLowerLimit': '-5.771', 'ciUpperLimit': '7.870', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.2816', 'groupDescription': '(R/14) × 100%', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (Baseline), Day 90', 'description': 'The participant was presented with a page that had lines placed across the page. The participant was required to cross out all the lines on the page using their non-paretic hand after the tester had demonstrated what was required by crossing out the center line. The performance measure for this task was the total number of omissions made expressed as a percentage of the total number of items in the test. The test contains 4 variables: (L+R)/28 × 100%, (L/14) × 100%, (R/14) × 100%, and (L-R)/(L+R), where L = number of lines crossed on the left side of the paper; R = number of lines crossed on the right side of the paper.', 'unitOfMeasure': 'change in percentage of lines crossed', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). n=number of participants included for comparison between active drug and placebo for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Domains of Interest: Change From Baseline in Line Cancellation Test at Day 90 [(L-R)/(L+R)] (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}, {'id': 'OG001', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.083', 'spread': '0.0620', 'groupId': 'OG000'}, {'value': '-0.023', 'spread': '0.0625', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1512', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.106', 'ciLowerLimit': '0.011', 'ciUpperLimit': '0.201', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0733', 'groupDescription': '(L R)/(L+R)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (Baseline), Day 90', 'description': 'The participant was presented with a page that had lines placed across the page. The participant was required to cross out all the lines on the page using their non-paretic hand after the tester had demonstrated what was required by crossing out the center line. The performance measure for this task was the total number of omissions made expressed as a percentage of the total number of items in the test. The test contains 4 variables: (L+R)/28 × 100%, (L/14) × 100%, (R/14) × 100%, and (L-R)/(L+R), where L = number of lines crossed on the left side of the paper; R = number of lines crossed on the right side of the paper.', 'unitOfMeasure': 'change in ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Number of participants analyzed indicated participants included for comparison between active drug and placebo for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Domains of Interest: Change From Baseline in Recognition Memory Test at Day 90 (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}, {'id': 'OG001', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.135', 'spread': '0.4743', 'groupId': 'OG000'}, {'value': '0.144', 'spread': '0.4797', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0128', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-1.279', 'ciLowerLimit': '-1.929', 'ciUpperLimit': '-0.629', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.5041', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (Baseline), Day 90', 'description': 'This test assesses the ability to recognize pictures of objects. The participant was presented a series of pictures, a subset of which were the objects presented in the RBANS Naming Sub Test. After each picture was presented, the participant indicated either manually (ie, affirmative head nod) or verbally whether the picture was seen previously. The participant was given 5 seconds per picture to respond. The performance measure for this task was the total number of pictures correctly identified.', 'unitOfMeasure': 'pictures correctly identified', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Participants analyzed indicated number of participants included for comparison between active drug and placebo for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Gait Velocity Test at Day 90 (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}, {'id': 'OG001', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.064', 'spread': '0.1040', 'groupId': 'OG000'}, {'value': '0.975', 'spread': '0.1128', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4713', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '0.089', 'ciLowerLimit': '-0.070', 'ciUpperLimit': '0.248', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1226', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 90', 'description': 'The 10-meter walk test requires a 20 meter straight path, with 5 meters for acceleration, 10 meters for steady state walking, and 5 meters for deceleration. Markers were placed at the 5 and 15 meter positions along the path. The participant began to walk "at a comfortable pace" at 1 end of the path, and continued walking until he/she reached the other end. The rater used a stopwatch to determine how much time it took for the participant to traverse the 10 meter center of the path, starting the stopwatch as soon as the participant\'s limb crossed the first marker and stopping the stopwatch as soon as the participant\'s limb crossed the second marker.', 'unitOfMeasure': 'meters/second (m/s)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Participants analyzed indicated number of participants included for comparison between active drug and placebo for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations of PF-03049423 (Part 1 and 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: PF-03049423 1 mg', 'description': 'Participants received PF-03049423 1 mg once daily for 90 days.'}, {'id': 'OG001', 'title': 'Cohort 2: PF-03049423 3 mg', 'description': 'Participants received PF-03049423 3 mg once daily for 90 days.'}, {'id': 'OG002', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}], 'classes': [{'title': 'Day 1 (0 hour predose), n=0, 1, 3', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No participants had concentration above lower limit quantification.', 'groupId': 'OG000'}, {'value': '0.05245', 'spread': '0.17397', 'groupId': 'OG001'}, {'value': '1.420', 'spread': '11.591', 'groupId': 'OG002'}]}]}, {'title': 'Day 1 (1 hour post dose), n=11, 10, 63', 'categories': [{'measurements': [{'value': '5.825', 'spread': '4.3514', 'groupId': 'OG000'}, {'value': '17.50', 'spread': '12.814', 'groupId': 'OG001'}, {'value': '46.76', 'spread': '36.153', 'groupId': 'OG002'}]}]}, {'title': 'Day 1 (2 hours post dose), n=11, 11, 61', 'categories': [{'measurements': [{'value': '7.063', 'spread': '3.2729', 'groupId': 'OG000'}, {'value': '30.18', 'spread': '11.313', 'groupId': 'OG001'}, {'value': '58.19', 'spread': '32.837', 'groupId': 'OG002'}]}]}, {'title': 'Day 1 (8 hours post dose), n=11, 11, 68', 'categories': [{'measurements': [{'value': '7.361', 'spread': '2.4032', 'groupId': 'OG000'}, {'value': '25.39', 'spread': '8.6644', 'groupId': 'OG001'}, {'value': '52.47', 'spread': '23.250', 'groupId': 'OG002'}]}]}, {'title': 'Day 2 (0 hour, predose), n=11, 11, 67', 'categories': [{'measurements': [{'value': '4.521', 'spread': '1.5265', 'groupId': 'OG000'}, {'value': '18.05', 'spread': '4.7834', 'groupId': 'OG001'}, {'value': '32.07', 'spread': '13.776', 'groupId': 'OG002'}]}]}, {'title': 'Day 7 (0 hour, post dose), n=9, 7, 64', 'categories': [{'measurements': [{'value': '8.601', 'spread': '2.9609', 'groupId': 'OG000'}, {'value': '27.79', 'spread': '7.6945', 'groupId': 'OG001'}, {'value': '53.08', 'spread': '30.237', 'groupId': 'OG002'}]}]}, {'title': 'Day 7 (1 hour post dose), n=0, 1, 59', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No samples were collected.', 'groupId': 'OG000'}, {'value': '51.80', 'spread': 'NA', 'comment': '1 participant had concentration above lower limit of quantification, SD cannot be calculated.', 'groupId': 'OG001'}, {'value': '115.9', 'spread': '65.329', 'groupId': 'OG002'}]}]}, {'title': 'Day 7 (2 hours post dose), n=0, 1, 59', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No samples were collected.', 'groupId': 'OG000'}, {'value': '58.10', 'spread': 'NA', 'comment': '1 participant had concentration above lower limit of quantification, SD cannot be calculated.', 'groupId': 'OG001'}, {'value': '126.3', 'spread': '57.759', 'groupId': 'OG002'}]}]}, {'title': 'Day 7 (6 hours post dose), n=0, 1, 61', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'No samples were collected.', 'groupId': 'OG000'}, {'value': '51.10', 'spread': 'NA', 'comment': '1 participant had concentration above lower limit of quantification, SD cannot be calculated.', 'groupId': 'OG001'}, {'value': '103.8', 'spread': '41.090', 'groupId': 'OG002'}]}]}, {'title': 'Day 14 (0 hour predose), n=10, 8, 59', 'categories': [{'measurements': [{'value': '7.805', 'spread': '2.9278', 'groupId': 'OG000'}, {'value': '31.13', 'spread': '9.8243', 'groupId': 'OG001'}, {'value': '53.10', 'spread': '28.085', 'groupId': 'OG002'}]}]}, {'title': 'Day 14 (1 hour post dose), n=9, 7, 0', 'categories': [{'measurements': [{'value': '16.47', 'spread': '7.1782', 'groupId': 'OG000'}, {'value': '76.71', 'spread': '32.657', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No samples were collected.', 'groupId': 'OG002'}]}]}, {'title': 'Day 14 (2 hours post dose), n=9, 6, 0', 'categories': [{'measurements': [{'value': '17.06', 'spread': '7.3799', 'groupId': 'OG000'}, {'value': '70.37', 'spread': '14.795', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'No samples were collected.', 'groupId': 'OG002'}]}]}, {'title': 'Day 14 (6 [cohort 3:4] hours post dose), n=9,7,31', 'categories': [{'measurements': [{'value': '17.57', 'spread': '4.1614', 'groupId': 'OG000'}, {'value': '58.36', 'spread': '11.720', 'groupId': 'OG001'}, {'value': '118.2', 'spread': '41.967', 'groupId': 'OG002'}]}]}, {'title': 'Day 30 (0 hour predose), n=6, 6, 58', 'categories': [{'measurements': [{'value': '5.339', 'spread': '3.5712', 'groupId': 'OG000'}, {'value': '29.68', 'spread': '11.015', 'groupId': 'OG001'}, {'value': '50.77', 'spread': '31.473', 'groupId': 'OG002'}]}]}, {'title': 'Day 30 (4 hours post dose), n=2, 5, 25', 'categories': [{'measurements': [{'value': '11.55', 'spread': '2.6234', 'groupId': 'OG000'}, {'value': '57.08', 'spread': '13.990', 'groupId': 'OG001'}, {'value': '96.27', 'spread': '49.929', 'groupId': 'OG002'}]}]}, {'title': 'Day 60 (0 hour predose), n=6, 6, 53', 'categories': [{'measurements': [{'value': '6.360', 'spread': '3.1028', 'groupId': 'OG000'}, {'value': '24.55', 'spread': '5.8206', 'groupId': 'OG001'}, {'value': '49.37', 'spread': '33.747', 'groupId': 'OG002'}]}]}, {'title': 'Day 60 (4 hours post dose), n=2, 5, 27', 'categories': [{'measurements': [{'value': '13.25', 'spread': '0.7778', 'groupId': 'OG000'}, {'value': '47.86', 'spread': '7.3296', 'groupId': 'OG001'}, {'value': '112.1', 'spread': '58.560', 'groupId': 'OG002'}]}]}, {'title': 'Day 90 (0 hour predose), n=5, 6, 45', 'categories': [{'measurements': [{'value': '5.252', 'spread': '1.5161', 'groupId': 'OG000'}, {'value': '29.18', 'spread': '15.909', 'groupId': 'OG001'}, {'value': '47.02', 'spread': '24.065', 'groupId': 'OG002'}]}]}, {'title': 'Day 90 (4 hours post dose), n=2, 5, 20', 'categories': [{'measurements': [{'value': '12.80', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '49.40', 'spread': '13.962', 'groupId': 'OG001'}, {'value': '82.69', 'spread': '29.005', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1, 2, 7, 14, 30, 60 and 90', 'unitOfMeasure': 'nanogram/milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK concentration population included all participants who were treated with PF-03049423 who had at least 1 measurable concentration. n=participants with concentration above lower limit of quantification at the corresponding sampling time.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'All-cause Mortality (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '67', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: PF-03049423 1 mg', 'description': 'Participants received PF-03049423 1 mg once daily for 90 days.'}, {'id': 'OG001', 'title': 'Cohort 1: Placebo', 'description': 'Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.'}, {'id': 'OG002', 'title': 'Cohort 2: PF-03049423 3 mg', 'description': 'Participants received PF-03049423 3 mg once daily for 90 days.'}, {'id': 'OG003', 'title': 'Cohort 2: Placebo', 'description': 'Participants received placebo matched to PF-03049423 3 mg once daily for 90 days.'}, {'id': 'OG004', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}, {'id': 'OG005', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-03049423 6 mg once daily for 90 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'The time began from the participant provided informed consent through 28 calendar days post last administration of investigational product.', 'description': 'Deaths regardless causality were reported.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all randomized participants who took any study medication (active or placebo).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mortality Directly Related to Stroke (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '67', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: PF-03049423 1 mg', 'description': 'Participants received PF-03049423 1 mg once daily for 90 days.'}, {'id': 'OG001', 'title': 'Cohort 1: Placebo', 'description': 'Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.'}, {'id': 'OG002', 'title': 'Cohort 2: PF-03049423 3 mg', 'description': 'Participants received PF-03049423 3 mg once daily for 90 days.'}, {'id': 'OG003', 'title': 'Cohort 2: Placebo', 'description': 'Participants received placebo matched to PF-03049423 3 mg once daily for 90 days.'}, {'id': 'OG004', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}, {'id': 'OG005', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-03049423 6 mg once daily for 90 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'The time began from the participant provided informed consent through 28 calendar days post last administration of investigational product.', 'description': 'Deaths caused by stroke were reported.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all randomized participants who took any study medication (active or placebo).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Neuro-worsening (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '67', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: PF-03049423 1 mg', 'description': 'Participants received PF-03049423 1 mg once daily for 90 days.'}, {'id': 'OG001', 'title': 'Cohort 1: Placebo', 'description': 'Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.'}, {'id': 'OG002', 'title': 'Cohort 2: PF-03049423 3 mg', 'description': 'Participants received PF-03049423 3 mg once daily for 90 days.'}, {'id': 'OG003', 'title': 'Cohort 2: Placebo', 'description': 'Participants received placebo matched to PF-03049423 3 mg once daily for 90 days.'}, {'id': 'OG004', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}, {'id': 'OG005', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-03049423 6 mg once daily for 90 days.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'No data were reported separately for this outcome measure, which was instead included in routine clinical review of NIHSS data.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data were reported separately for this outcome measure, which was instead included in routine clinical review of NIHSS data.', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'No data were reported separately for this outcome measure, which was instead included in routine clinical review of NIHSS data.', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data were reported separately for this outcome measure, which was instead included in routine clinical review of NIHSS data.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'No data were reported separately for this outcome measure, which was instead included in routine clinical review of NIHSS data.', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'No data were reported separately for this outcome measure, which was instead included in routine clinical review of NIHSS data.', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Baseline) up to Day 90', 'description': 'NIHSS change of 4 points or greater.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all randomized participants who took any study medication (active or placebo).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With SBP <100 mm Hg or SBP Decline >=30 mm Hg From Immediate Pre-dose Measurement, With or Without Neuro-worsening (Defined as an NIHSS Increase of 4 Points or Greater) Within 2 Hours Post-dose (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '67', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: PF-03049423 1 mg', 'description': 'Participants received PF-03049423 1 mg once daily for 90 days.'}, {'id': 'OG001', 'title': 'Cohort 1: Placebo', 'description': 'Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.'}, {'id': 'OG002', 'title': 'Cohort 2: PF-03049423 3 mg', 'description': 'Participants received PF-03049423 3 mg once daily for 90 days.'}, {'id': 'OG003', 'title': 'Cohort 2: Placebo', 'description': 'Participants received placebo matched to PF-03049423 3 mg once daily for 90 days.'}, {'id': 'OG004', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}, {'id': 'OG005', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-03049423 6 mg once daily for 90 days.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'No data were reported separately for this outcome measure, which was instead included in routine clinical review of BP data.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'No data were reported separately for this outcome measure, which was instead included in routine clinical review of BP data.', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'No data were reported separately for this outcome measure, which was instead included in routine clinical review of BP data.', 'groupId': 'OG002'}, {'value': 'NA', 'comment': 'No data were reported separately for this outcome measure, which was instead included in routine clinical review of BP data.', 'groupId': 'OG003'}, {'value': 'NA', 'comment': 'No data were reported separately for this outcome measure, which was instead included in routine clinical review of BP data.', 'groupId': 'OG004'}, {'value': 'NA', 'comment': 'No data were reported separately for this outcome measure, which was instead included in routine clinical review of BP data.', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Baseline) up to Day 14', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all randomized participants who took any study medication (active or placebo).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Treatment-emergent Adverse Events (AEs) Resulting in Discontinuation of Study Drug (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}, {'value': '67', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: PF-03049423 1 mg', 'description': 'Participants received PF-03049423 1 mg once daily for 90 days.'}, {'id': 'OG001', 'title': 'Cohort 1: Placebo', 'description': 'Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.'}, {'id': 'OG002', 'title': 'Cohort 2: PF-03049423 3 mg', 'description': 'Participants received PF-03049423 3 mg once daily for 90 days.'}, {'id': 'OG003', 'title': 'Cohort 2: Placebo', 'description': 'Participants received placebo matched to PF-03049423 3 mg once daily for 90 days.'}, {'id': 'OG004', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}, {'id': 'OG005', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-03049423 6 mg once daily for 90 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Baseline) up to follow-up (28 days after Day 90)', 'description': 'An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS consisted of all randomized participants who took any study medication (active or placebo).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Box and Blocks (B&B) Test at Day 90 for Non-paretic Hand (Part 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}, {'id': 'OG001', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.797', 'spread': '2.1676', 'groupId': 'OG000'}, {'value': '18.313', 'spread': '2.2407', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8501', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.516', 'ciLowerLimit': '-4.026', 'ciUpperLimit': '2.995', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.7201', 'groupDescription': 'Non-paretic hand', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 (Baseline), Day 90', 'description': 'The B\\&B test is a measure of manual dexterity. The B\\&B apparatus consists of a box divided into 2 sections and 1-inch hardwood blocks. The blocks began in the compartment of the test box to the dominant side of the participant. The participant was required to transfer the blocks one at a time to the other side of the box as quickly as possible in 1 minute using the non-paretic hand. The box was then turned so all the blocks were in the same side as the paretic hand. The participant was then required to do the test with his/her paretic hand. The participant was told that if more than 1 block was picked up at a time it was to only count as 1 block. The participant was also told that their fingertips needed to cross the partition for the block to be counted. The performance measure for this task was the number of blocks moved within 1 minute.', 'unitOfMeasure': 'blocks moved per minute', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The I-FAS consisted of participants within the FAS who were randomized to PF-03049423 MTD or highest dose (6 mg) group or the placebo group that was in the same cohort as the MTD or highest dose (6 mg). Number of participants indicated those participants included for comparison between active drug and placebo.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1: PF-03049423 1 mg', 'description': 'Participants received PF-03049423 1 mg once daily for 90 days.'}, {'id': 'FG001', 'title': 'Cohort 1: Placebo', 'description': 'Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.'}, {'id': 'FG002', 'title': 'Cohort 2: PF-03049423 3 mg', 'description': 'Participants received PF-03049423 3 mg once daily for 90 days.'}, {'id': 'FG003', 'title': 'Cohort 2: Placebo', 'description': 'Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.'}, {'id': 'FG004', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}, {'id': 'FG005', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '70'}, {'groupId': 'FG005', 'numSubjects': '67'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '46'}, {'groupId': 'FG005', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '24'}, {'groupId': 'FG005', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '5'}]}, {'type': 'Did not meet entrance criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Medication error without adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'A total of 181 participants were assigned to study treatment, 178 of which received study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '70', 'groupId': 'BG004'}, {'value': '67', 'groupId': 'BG005'}, {'value': '178', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1: PF-03049423 1 mg', 'description': 'Participants received PF-03049423 1 mg once daily for 90 days.'}, {'id': 'BG001', 'title': 'Cohort 1: Placebo', 'description': 'Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.'}, {'id': 'BG002', 'title': 'Cohort 2: PF-03049423 3 mg', 'description': 'Participants received PF-03049423 3 mg once daily for 90 days.'}, {'id': 'BG003', 'title': 'Cohort 2: Placebo', 'description': 'Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.'}, {'id': 'BG004', 'title': 'Cohort 3: PF-03049423 6 mg', 'description': 'Participants received PF-03049423 6 mg once daily for 90 days.'}, {'id': 'BG005', 'title': 'Cohort 3: Placebo', 'description': 'Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.3', 'spread': '14.3', 'groupId': 'BG000'}, {'value': '64.7', 'spread': '6.0', 'groupId': 'BG001'}, {'value': '69.8', 'spread': '8.3', 'groupId': 'BG002'}, {'value': '65.8', 'spread': '13.4', 'groupId': 'BG003'}, {'value': '64.2', 'spread': '13.1', 'groupId': 'BG004'}, {'value': '65.6', 'spread': '11.3', 'groupId': 'BG005'}, {'value': '65.1', 'spread': '12.0', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '26', 'groupId': 'BG005'}, {'value': '70', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}, {'value': '41', 'groupId': 'BG005'}, {'value': '108', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Full Analysis Set (FAS) consisted of all randomized participants who took any study medication (active or placebo).'}}, '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': 181}}, 'statusModule': {'whyStopped': 'See termination reason in detailed description.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-22', 'studyFirstSubmitDate': '2010-09-22', 'resultsFirstSubmitDate': '2015-02-19', 'studyFirstSubmitQcDate': '2010-09-22', 'lastUpdatePostDateStruct': {'date': '2016-02-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-01-22', 'studyFirstPostDateStruct': {'date': '2010-09-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'All-cause Mortality (Part 2)', 'timeFrame': 'The time began from the participant provided informed consent through 28 calendar days post last administration of investigational product.', 'description': 'Deaths regardless causality were reported.'}, {'measure': 'Mortality Directly Related to Stroke (Part 2)', 'timeFrame': 'The time began from the participant provided informed consent through 28 calendar days post last administration of investigational product.', 'description': 'Deaths caused by stroke were reported.'}, {'measure': 'Number of Participants With Neuro-worsening (Part 2)', 'timeFrame': 'Day 1 (Baseline) up to Day 90', 'description': 'NIHSS change of 4 points or greater.'}, {'measure': 'Number of Participants With SBP <100 mm Hg or SBP Decline >=30 mm Hg From Immediate Pre-dose Measurement, With or Without Neuro-worsening (Defined as an NIHSS Increase of 4 Points or Greater) Within 2 Hours Post-dose (Part 2)', 'timeFrame': 'Day 1 (Baseline) up to Day 14'}, {'measure': 'Treatment-emergent Adverse Events (AEs) Resulting in Discontinuation of Study Drug (Part 2)', 'timeFrame': 'Day 1 (Baseline) up to follow-up (28 days after Day 90)', 'description': 'An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Any Abnormal Laboratory Test Results (Part 1* and 2)', 'timeFrame': 'Day 1 (Baseline) up to Day 90', 'description': 'The total number of participants with laboratory test abnormalities (without regard to baseline abnormality) was assessed. \\*This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.'}, {'measure': 'Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern (Part 1* and 2)', 'timeFrame': 'Day 1 (Baseline) up to follow-up (28 days after Day 90)', 'description': 'Vital signs included blood pressure (BP; supine, sitting and standing) and pulse rate. Vital signs criteria of potential clinical concern were 1), BP: systolic BP (SBP) greater than or equal to (\\>=) 30 or 50 millimeters of mercury (mm Hg) change from grand baseline in same posture, systolic less than (\\<) 90 mm Hg; diastolic BP (DBP) \\>=20 mm Hg change from grand baseline in same posture, diastolic \\<50 mm Hg; 2), pulse rate (supine, sitting and standing): \\<40 or greater than (\\>) 120 beats per minute (bpm); Standing: \\<40 or \\>140 bpm. \\*This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.'}, {'measure': 'Number of Participants With Electrocardiograms (ECGs) Data Met Criteria of Potential Clinical Concern (Part 1* and 2)', 'timeFrame': 'Day 1 (Baseline) to Day 90', 'description': "ECG criteria of potential clinical concern were 1), PR interval: \\>=300 milliseconds (msec); \\>=25% increase when baseline \\>200 msec; or increase \\>=50% when baseline \\<=200 msec; 2), QRS interval: \\>=140 msec; \\>=50% increase from baseline; 3), QT interval: \\>=500 msec, QTc interval using Fridericia's formula (QTcF interval): absolute value \\>=450 - \\<480 msec, \\>=480-\\<500 msec, \\>=500 msec; absolute change 30 - \\<60, \\>=60 msec. \\*This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together."}, {'measure': 'Number of Participants With Significant Change in Physical Examination Findings (Part 1* and 2)', 'timeFrame': 'Day 1 (Baseline) up to Day 90', 'description': 'The complete physical examination included examination of the skin, eyes, ears, throat, neck, cardiac, respiratory, gastrointestinal, and musculoskeletal systems. The limited physical examination included examination of the cardiac, respiratory, gastrointestinal, and musculoskeletal systems. \\*This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.'}, {'measure': 'Number of Participants With Significant Change in Neurological Examination Findings (Part 1* and 2)', 'timeFrame': 'Day 1 (Baseline) up to Day 90', 'description': 'The complete neurological examination included an assessment of the motor, sensory, cranial nerves, reflexes, mental status and associated motor functions. The limited neurological exam could examine the same categories of neurologic assessments as the full examination, but would differ by the depth in the examination. The examination was required to be done to the extent needed to assess the participant for any potential changes in neurological status, as determined by the Investigator, but had to always include an assessment of motor, vision and hearing. \\*This endpoint was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for this timeframe were not reported separately, Part 1 and 2 data were reported together.'}, {'measure': 'Number of Participants With Suicidal Behavior and/or Ideation as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) (Part 1* and 2)', 'timeFrame': 'Day 7 (Baseline) up to follow up (28 days after Day 90)', 'description': 'Data were mapped to Columbia-Classification Algorithm of Suicide Assessment (C-CASA) event codes. C-SSRS assessed if participant experienced: completed suicide (Code 1), suicide attempt (Code 2) (Response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (Code 3) ("Yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"), suicidal ideation (Code 4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Code 7) ("Yes" on "Has participant engaged in non-suicidal self-injurious behavior"). Number of participants with "Yes" response for any of above mentioned categories was assessed. \\*This was a primary endpoint for Part 1 (timeframe Days 1 to 14), as data for it were not reported separately, Part 1 and 2 data were reported together.'}, {'measure': 'Percentage of Participants With Modified Rankin Scale (mRS) Less Than or Equal to (<=2) at Day 90 (Part 2)', 'timeFrame': 'Day 90', 'description': 'The mRS is a 6-point scale of functional recovery. The scale grades participants as having no symptoms (0), minor symptoms (1), minor handicap (2), moderate handicap (3), moderately severe handicap (4), severe handicap (5), or death (6).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Box and Blocks (B&B) Test at Day 90 for Paretic Hand (Part 2)', 'timeFrame': 'Day 1 (Baseline), Day 90', 'description': 'The B\\&B test is a measure of manual dexterity. The B\\&B apparatus consists of a box divided into 2 sections and 1-inch hardwood blocks. The blocks began in the compartment of the test box to the dominant side of the participant. The participant was required to transfer the blocks one at a time to the other side of the box as quickly as possible in 1 minute using the non-paretic hand. The box was then turned so all the blocks were in the same side as the paretic hand. The participant was then required to do the test with his/her paretic hand. The participant was told that if more than 1 block was picked up at a time it was to only count as 1 block. The participant was also told that their fingertips needed to cross the partition for the block to be counted. The performance measure for this task was the number of blocks moved within 1 minute.'}, {'measure': 'Change From Baseline in Box and Blocks (B&B) Test at Day 90 for Paretic to Non-paretic Hand Ratio (Part 2)', 'timeFrame': 'Day 1 (Baseline), Day 90', 'description': 'The B\\&B test is a measure of manual dexterity. The B\\&B apparatus consists of a box divided into 2 sections and 1-inch hardwood blocks. The blocks began in the compartment of the test box to the dominant side of the participant. The participant was required to transfer the blocks one at a time to the other side of the box as quickly as possible in 1 minute using the non-paretic hand. The box was then turned so all the blocks were in the same side as the paretic hand. The participant was then required to do the test with his/her paretic hand. The participant was told that if more than 1 block was picked up at a time it was to only count as 1 block. The participant was also told that their fingertips needed to cross the partition for the block to be counted. The performance measure for this task was the number of blocks moved within 1 minute.'}, {'measure': 'Change From Baseline in Hand Grip Strength Test at Day 90 for Paretic and Non-paretic Hands (Part 2)', 'timeFrame': 'Day 1 (Baseline), Day 90', 'description': 'The Hand Grip Strength Test measures the maximum isometric strength of the hand and forearm muscles. The participant was required to squeeze the dynamometer with maximum isometric effort while sitting with shoulder adducted and neutrally roated, elbow flexed at 90 degrees and the forearm in neutral position and wrist between 0 to 30 degrees dorsiflexion and a 0 to 15 degrees ulnar deviation. The participant performed this task 3 times with each hand, starting with the non-paretic hand. The performance measure for this task was the average score measured in pounds of pressure exerted.'}, {'measure': 'Change From Baseline in Hand Grip Strength Test at Day 90 for Paretic to Non-paretic Hand Ratio (Part 2)', 'timeFrame': 'Day 1 (Baseline), Day 90', 'description': 'The Hand Grip Strength Test measures the maximum isometric strength of the hand and forearm muscles. The participant was required to squeeze the dynamometer with maximum isometric effort while sitting with shoulder adducted and neutrally roated, elbow flexed at 90 degrees and the forearm in neutral position and wrist between 0 to 30 degrees dorsiflexion and a 0 to 15 degrees ulnar deviation. The participant performed this task 3 times with each hand, starting with the non-paretic hand. The performance measure for this task was the average score measured in pounds of pressure exerted.'}, {'measure': 'Percentage of Participants With mRS (0-1) at Day 90 (Part 2)', 'timeFrame': 'Day 90', 'description': 'The mRS is a 6-point scale of functional recovery. The scale grades participants as having no symptoms (0), minor symptoms (1), minor handicap (2), moderate handicap (3), moderately severe handicap (4), severe handicap (5), or death (6).'}, {'measure': 'Percentage of Participants With National Institutes of Health Stroke Scale (NIHSS) (0-1) at Day 90 (Part 2)', 'timeFrame': 'Day 90', 'description': 'The NIHSS is a graded 11-item neurological examination rating speech and language, cognition, visual field deficits, motor and sensory impairments and ataxia used for the clinical assessment of acute stroke therapy. The maximum total score is 42 in a participant with a severe neurological deficit; the minimum score is 0 in a participant without gross neurological deficits.'}, {'measure': 'Change From Baseline in NIHSS at Day 90 (Part 2)', 'timeFrame': 'Day 1 (Baseline), Day 90', 'description': 'The NIHSS is a graded 11-item neurological examination rating speech and language, cognition, visual field deficits, motor and sensory impairments and ataxia used for the clinical assessment of acute stroke therapy. The maximum total score is 42 in a participant with a severe neurological deficit; the minimum score is 0 in a participant without gross neurological deficits.'}, {'measure': 'Percentage of Participants With Barthel Index (BI) >= 95 and BI =100 at Day 90 (Part 2)', 'timeFrame': 'Day 90', 'description': "The BI is an index of independence to score the ability of a participant with a neuromuscular or musculoskeletal disorder to care for him or herself. The index rates a participant's ability on the following 10 activities: feeding, moving from wheelchair to bed, personal toilet, getting on and off toilet, bathing self, walking on level surface, ascending and descending stairs, dressing, controlling bowels and controlling bladder. The maximum total score is 100 in a participant without functional impairment; the minimum score is 0 in a participant with major functional impairment."}, {'measure': 'BI at Day 90 (Part 2)', 'timeFrame': 'Day 90', 'description': "The BI is an index of independence to score the ability of a participant with a neuromuscular or musculoskeletal disorder to care for him or herself. The index rates a participant's ability on the following 10 activities: feeding, moving from wheelchair to bed, personal toilet, getting on and off toilet, bathing self, walking on level surface, ascending and descending stairs, dressing, controlling bowels and controlling bladder. The maximum total score is 100 in a participant without functional impairment; the minimum score is 0 in a participant with major functional impairment."}, {'measure': 'Domains of Interest: Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Coding Sub Test at Day 90 (Part 2)', 'timeFrame': 'Day 1 (Baseline), Day 90', 'description': 'The test uses a reference key, the participant had 90 seconds to pair specific numbers with given geometric figures. Responses could be written or oral. The performance measure for this task was the total number of correct responses.'}, {'measure': 'Domains of Interest: Change From Baseline in RBANS Naming Sub Test at Day 90 (Part 2)', 'timeFrame': 'Day 1 (Baseline), Day 90', 'description': 'This test requires the participant to name 10 objects drawn in ink. The tester asked the participant to identify the picture. The participant had 20 seconds to respond to each picture presented. The performance measure was the number of objects named correctly.'}, {'measure': 'Domains of Interest: Change From Baseline in Line Cancellation Test [(L+R)/28 × 100%, (L/14) × 100%, (R/14) × 100%)] at Day 90 (Part 2)', 'timeFrame': 'Day 1 (Baseline), Day 90', 'description': 'The participant was presented with a page that had lines placed across the page. The participant was required to cross out all the lines on the page using their non-paretic hand after the tester had demonstrated what was required by crossing out the center line. The performance measure for this task was the total number of omissions made expressed as a percentage of the total number of items in the test. The test contains 4 variables: (L+R)/28 × 100%, (L/14) × 100%, (R/14) × 100%, and (L-R)/(L+R), where L = number of lines crossed on the left side of the paper; R = number of lines crossed on the right side of the paper.'}, {'measure': 'Domains of Interest: Change From Baseline in Line Cancellation Test at Day 90 [(L-R)/(L+R)] (Part 2)', 'timeFrame': 'Day 1 (Baseline), Day 90', 'description': 'The participant was presented with a page that had lines placed across the page. The participant was required to cross out all the lines on the page using their non-paretic hand after the tester had demonstrated what was required by crossing out the center line. The performance measure for this task was the total number of omissions made expressed as a percentage of the total number of items in the test. The test contains 4 variables: (L+R)/28 × 100%, (L/14) × 100%, (R/14) × 100%, and (L-R)/(L+R), where L = number of lines crossed on the left side of the paper; R = number of lines crossed on the right side of the paper.'}, {'measure': 'Domains of Interest: Change From Baseline in Recognition Memory Test at Day 90 (Part 2)', 'timeFrame': 'Day 1 (Baseline), Day 90', 'description': 'This test assesses the ability to recognize pictures of objects. The participant was presented a series of pictures, a subset of which were the objects presented in the RBANS Naming Sub Test. After each picture was presented, the participant indicated either manually (ie, affirmative head nod) or verbally whether the picture was seen previously. The participant was given 5 seconds per picture to respond. The performance measure for this task was the total number of pictures correctly identified.'}, {'measure': 'Gait Velocity Test at Day 90 (Part 2)', 'timeFrame': 'Day 90', 'description': 'The 10-meter walk test requires a 20 meter straight path, with 5 meters for acceleration, 10 meters for steady state walking, and 5 meters for deceleration. Markers were placed at the 5 and 15 meter positions along the path. The participant began to walk "at a comfortable pace" at 1 end of the path, and continued walking until he/she reached the other end. The rater used a stopwatch to determine how much time it took for the participant to traverse the 10 meter center of the path, starting the stopwatch as soon as the participant\'s limb crossed the first marker and stopping the stopwatch as soon as the participant\'s limb crossed the second marker.'}, {'measure': 'Plasma Concentrations of PF-03049423 (Part 1 and 2)', 'timeFrame': 'Days 1, 2, 7, 14, 30, 60 and 90'}, {'measure': 'Change From Baseline in Box and Blocks (B&B) Test at Day 90 for Non-paretic Hand (Part 2)', 'timeFrame': 'Day 1 (Baseline), Day 90', 'description': 'The B\\&B test is a measure of manual dexterity. The B\\&B apparatus consists of a box divided into 2 sections and 1-inch hardwood blocks. The blocks began in the compartment of the test box to the dominant side of the participant. The participant was required to transfer the blocks one at a time to the other side of the box as quickly as possible in 1 minute using the non-paretic hand. The box was then turned so all the blocks were in the same side as the paretic hand. The participant was then required to do the test with his/her paretic hand. The participant was told that if more than 1 block was picked up at a time it was to only count as 1 block. The participant was also told that their fingertips needed to cross the partition for the block to be counted. The performance measure for this task was the number of blocks moved within 1 minute.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Phase 2 Ischemic stroke Safety and efficacy'], 'conditions': ['Ischemic Stroke']}, 'referencesModule': {'references': [{'pmid': '26738812', 'type': 'DERIVED', 'citation': 'Di Cesare F, Mancuso J, Woodward P, Bednar MM, Loudon PT; A9541004 Stroke Study Group. Phosphodiesterase-5 Inhibitor PF-03049423 Effect on Stroke Recovery: A Double-Blind, Placebo-Controlled Randomized Clinical Trial. J Stroke Cerebrovasc Dis. 2016 Mar;25(3):642-9. doi: 10.1016/j.jstrokecerebrovasdis.2015.11.026. Epub 2015 Dec 28.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9541004&StudyName=Study%20Evaluating%20The%20Safety%20And%20Efficacy%20Of%20PF-03049423%20In%20Subjects%20With%20Ischemic%20Stroke', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and tolerability of PF-03049423 following multiple dose administration to subjects with ischemic stroke. The study will also evaluate the efficacy of PF-03049423, relative to placebo, in subjects with ischemic stroke following 90 days of therapy. The study will also explore the relationship between PF-03049423 concentration and blood pressure.', 'detailedDescription': 'The interim analysis for the POC study A9541004 demonstrated futility, and the study was stopped on the 6th of November 2013. There were no signals of serious safety concern.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of ischemic stroke with an onset within 72 hours prior to start of study agent administration, male or female.\n* Supratentorial ischemic stroke involving the cortex documented by neurological exam and confirmed by MRI.\n* Stroke involving upper extremity.\n* Subjects who received thrombolytic therapy may be enrolled and the use of antiplatelet is acceptable.\n\nExclusion Criteria:\n\n* Any other severe acute or chronic medical or psychiatric condition besides the stroke.\n* Women of child bearing potential.\n* Uncontrolled hypertension.'}, 'identificationModule': {'nctId': 'NCT01208233', 'briefTitle': 'Study Evaluating The Safety And Efficacy Of PF-03049423 In Subjects With Ischemic Stroke', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 2 Multicenter, Randomized, Double Blind, Placebo Controlled Study Of The Safety And Efficacy Of Pf-03049423 In Subjects With Ischemic Stroke', 'orgStudyIdInfo': {'id': 'A9541004'}, 'secondaryIdInfos': [{'id': '2010-021414-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 mg PF-03049423', 'interventionNames': ['Drug: PF-03049423']}, {'type': 'EXPERIMENTAL', 'label': '3 mg of PF-03049423', 'interventionNames': ['Drug: PF-03049423']}, {'type': 'EXPERIMENTAL', 'label': '6 mg of PF-03049423', 'interventionNames': ['Drug: PF-03049423']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'PF-03049423', 'type': 'DRUG', 'description': '1 mg of PF-03049423 daily for 90 days', 'armGroupLabels': ['1 mg PF-03049423']}, {'name': 'PF-03049423', 'type': 'DRUG', 'description': '3 mg of PF-03049423 daily for 90 days', 'armGroupLabels': ['3 mg of PF-03049423']}, {'name': 'PF-03049423', 'type': 'DRUG', 'description': '6 mg of PF-03049423 daily for 90 days', 'armGroupLabels': ['6 mg of PF-03049423']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo of PF-03049423 daily for 90 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Spain Rehabilitation Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'The Kirklin Clinic', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35294-3280', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University Hospital', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '33064', 'city': 'Deerfield Beach', 'state': 'Florida', 'country': 'United States', 'facility': 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'lon': -83.04575}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Barnes-Jewish Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Rehabilitation Institute of St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC HealthCare', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27599-7025', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Department of Neurology Stroke Division', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Investigational Drug Services at OU Medical Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '73104', 'city': 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'state': 'Texas', 'country': 'United States', 'facility': 'The Methodist Hospital Neurological Institute', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '5800', 'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'Voennomeditsinska Akademia - MBAL- Pleven, Otdelenie po Nervni bolesti', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'zip': '4002', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'MBAL Kaspela', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '1113', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'MBALNP "Sveti Naum" EAD, Klinika za Intenzivno Lechenie na Nervni Bolesti', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1202', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Vtora Mnogoprofilna Bolnitsa za Aktivno Lechenie, Otdelenie po Nevrologia', 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'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'zip': '431-070', 'city': 'Anyang-si', 'state': 'Gyonggi-do', 'country': 'South Korea', 'facility': 'Hallym University Sacred Heart Hospital, Department of Neurology', 'geoPoint': {'lat': 37.3925, 'lon': 126.92694}}, {'zip': '501-757', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chonnam National University Hospital, Department of Neurology', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'zip': '400-711', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Inha University Hospital, Department of Neurology', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital, Yonsei University College of Medicine, Department of Neurology', 'geoPoint': {'lat': 37.566, 'lon': 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