Viewing Study NCT03334851

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Ignite Creation Date: 2025-12-24 @ 11:43 PM
Ignite Modification Date: 2026-02-25 @ 6:59 PM
Study NCT ID: NCT03334851
Status: COMPLETED
Last Update Posted: 2023-10-30
First Post: 2017-11-03
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo IV SAD', 'description': 'Participants received single dose of placebo on Day 1 as an intravenous (IV) infusion.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'PF-06835375 0.03 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'PF-06835375 0.1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'PF-06835375 0.3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'PF-06835375 1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'PF-06835375 3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'PF-06835375 6 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Placebo SC MAD', 'description': 'Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 9, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'PF-06835375 0.3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'PF-06835375 1 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'PF-06835375 3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 5, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'PF-06835375 6 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': 'PF-06835375 10 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Lip swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Injection site scab', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, 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'Hypercalciuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Nocturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Stag horn calculus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Dose-Limiting Toxicity (DLT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo IV SAD', 'description': 'Participants received single dose of placebo on Day 1 as an intravenous (IV) infusion.'}, {'id': 'OG001', 'title': 'PF-06835375 0.03 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.'}, {'id': 'OG002', 'title': 'PF-06835375 0.1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.'}, {'id': 'OG003', 'title': 'PF-06835375 0.3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.'}, {'id': 'OG004', 'title': 'PF-06835375 1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.'}, {'id': 'OG005', 'title': 'PF-06835375 3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.'}, {'id': 'OG006', 'title': 'PF-06835375 6 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.'}, {'id': 'OG007', 'title': 'Placebo SC MAD', 'description': 'Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG008', 'title': 'PF-06835375 0.3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG009', 'title': 'PF-06835375 1 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG010', 'title': 'PF-06835375 3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG011', 'title': 'PF-06835375 6 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG012', 'title': 'PF-06835375 10 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)', 'description': 'DLT was defined as any of the following events meeting the criteria: (1) \\>=2 participants within a dose cohort developed Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grade 3 adverse event considered to be serious in the same organ system or 1 participant developed a CTCAE v4.0 Grade 4 or higher SAE considered related to study drug; (2) 50% or more participants within a dose cohort experienced a CTCAE v4.0 Grade 3 or higher infusion reaction; (3) a confirmed or probable case of Progressive Multifocal Leukoencephalopathy was observed; (4) the mean exposure for the treatment group reached or exceeded the exposure stopping limit of Cav of 261 mg/mL, or, based on the observed data, the group mean Cav of the next planned dose was projected to exceed the exposure stopping limit. Cav = average serum concentration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo IV SAD', 'description': 'Participants received single dose of placebo on Day 1 as an intravenous (IV) infusion.'}, {'id': 'OG001', 'title': 'PF-06835375 0.03 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.'}, {'id': 'OG002', 'title': 'PF-06835375 0.1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.'}, {'id': 'OG003', 'title': 'PF-06835375 0.3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.'}, {'id': 'OG004', 'title': 'PF-06835375 1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.'}, {'id': 'OG005', 'title': 'PF-06835375 3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.'}, {'id': 'OG006', 'title': 'PF-06835375 6 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.'}, {'id': 'OG007', 'title': 'Placebo SC MAD', 'description': 'Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG008', 'title': 'PF-06835375 0.3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG009', 'title': 'PF-06835375 1 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG010', 'title': 'PF-06835375 3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG011', 'title': 'PF-06835375 6 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG012', 'title': 'PF-06835375 10 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}], 'classes': [{'title': 'Mild (all causalities)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}]}]}, {'title': 'Moderate (all causalities)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}]}]}, {'title': 'Severe (all causalities)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': 'Mild (treatment-related)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}]}]}, {'title': 'Moderate (treatment-related)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}]}]}, {'title': 'Severe (treatment-related)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)', 'description': "An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator. Treatment-emergent were events between first dose of study drug and up to approximately Week 40 that were absent before treatment or that worsened relative to pretreatment state. AEs are classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With All-Causality and Treatment-Related TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo IV SAD', 'description': 'Participants received single dose of placebo on Day 1 as an intravenous (IV) infusion.'}, {'id': 'OG001', 'title': 'PF-06835375 0.03 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.'}, {'id': 'OG002', 'title': 'PF-06835375 0.1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.'}, {'id': 'OG003', 'title': 'PF-06835375 0.3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.'}, {'id': 'OG004', 'title': 'PF-06835375 1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.'}, {'id': 'OG005', 'title': 'PF-06835375 3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.'}, {'id': 'OG006', 'title': 'PF-06835375 6 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.'}, {'id': 'OG007', 'title': 'Placebo SC MAD', 'description': 'Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG008', 'title': 'PF-06835375 0.3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG009', 'title': 'PF-06835375 1 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG010', 'title': 'PF-06835375 3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG011', 'title': 'PF-06835375 6 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG012', 'title': 'PF-06835375 10 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}], 'classes': [{'title': 'Number of Participants with all-causality TEAEs', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}]}, {'title': 'Number of Participants with all-causality SAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': 'Number of Participants with treatment-related TEAEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}]}, {'title': 'Number of Participants with treatment-related SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to approximately Week 40 that were absent before treatment or that worsened relative to pretreatment state.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Permanent Discontinuation Due to TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo IV SAD', 'description': 'Participants received single dose of placebo on Day 1 as an intravenous (IV) infusion.'}, {'id': 'OG001', 'title': 'PF-06835375 0.03 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.'}, {'id': 'OG002', 'title': 'PF-06835375 0.1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.'}, {'id': 'OG003', 'title': 'PF-06835375 0.3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.'}, {'id': 'OG004', 'title': 'PF-06835375 1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.'}, {'id': 'OG005', 'title': 'PF-06835375 3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.'}, {'id': 'OG006', 'title': 'PF-06835375 6 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.'}, {'id': 'OG007', 'title': 'Placebo SC MAD', 'description': 'Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG008', 'title': 'PF-06835375 0.3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG009', 'title': 'PF-06835375 1 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG010', 'title': 'PF-06835375 3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG011', 'title': 'PF-06835375 6 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG012', 'title': 'PF-06835375 10 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)', 'description': 'An AE was 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 approximately Week 40 that were absent before treatment or that worsened relative to pretreatment state.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically Significant Laboratory Abnormalities in Hematology, Chemistry, and Urinalysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo IV SAD', 'description': 'Participants received single dose of placebo on Day 1 as an intravenous (IV) infusion.'}, {'id': 'OG001', 'title': 'PF-06835375 0.03 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.'}, {'id': 'OG002', 'title': 'PF-06835375 0.1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.'}, {'id': 'OG003', 'title': 'PF-06835375 0.3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.'}, {'id': 'OG004', 'title': 'PF-06835375 1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.'}, {'id': 'OG005', 'title': 'PF-06835375 3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.'}, {'id': 'OG006', 'title': 'PF-06835375 6 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.'}, {'id': 'OG007', 'title': 'Placebo SC MAD', 'description': 'Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG008', 'title': 'PF-06835375 0.3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG009', 'title': 'PF-06835375 1 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG010', 'title': 'PF-06835375 3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG011', 'title': 'PF-06835375 6 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG012', 'title': 'PF-06835375 10 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}], 'classes': [{'title': 'Elevated creatine phosphokinase (CPK)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': 'Elevated liver enzymes (AST and ALT increased)', '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'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': 'Elevated liver function tests (AST and ALT increased)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline up to end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)', 'description': 'Hematology included hemoglobin, hematocrit, red blood cell, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet and white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. Chemistry included blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein and creatine kinase. Urinalysis included pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy and creatinine. Clinical significance was judged by the investigator and those met the criteria of AE are listed here. Clinically significant laboratory abnormalities reported for at least 1 participant in the whole study are presented here. Baseline was the last pre-dose measurement (first treatment for MAD cohorts).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo IV SAD', 'description': 'Participants received single dose of placebo on Day 1 as an intravenous (IV) infusion.'}, {'id': 'OG001', 'title': 'PF-06835375 0.03 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.'}, {'id': 'OG002', 'title': 'PF-06835375 0.1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.'}, {'id': 'OG003', 'title': 'PF-06835375 0.3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.'}, {'id': 'OG004', 'title': 'PF-06835375 1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.'}, {'id': 'OG005', 'title': 'PF-06835375 3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.'}, {'id': 'OG006', 'title': 'PF-06835375 6 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.'}, {'id': 'OG007', 'title': 'Placebo SC MAD', 'description': 'Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG008', 'title': 'PF-06835375 0.3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG009', 'title': 'PF-06835375 1 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG010', 'title': 'PF-06835375 3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG011', 'title': 'PF-06835375 6 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG012', 'title': 'PF-06835375 10 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}], 'classes': [{'title': 'Sitting Systolic BP <90 mmHg', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': 'Maximum Increase from Baseline in Sitting Systolic BP >= 30 mmHg', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}]}]}, {'title': 'Maximum Decrease from Baseline in Sitting Systolic BP >= 30 mmHg', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '1', 'groupId': 'OG012'}]}]}, {'title': 'Sitting Diastolic BP <50 mmHg', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': 'Maximum Increase from Baseline in Sitting Diastolic BP >= 20 mmHg', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}]}, {'title': 'Maximum Decrease from Baseline in Sitting Diastolic BP >= 20 mmHg', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline up to end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)', 'description': 'Criteria for abnormality in vital signs: supine pulse rate \\<40 beats per minute (bpm) or \\>120 bpm; standing pulse rate \\<40 bpm or \\>120 bpm; sitting systolic blood pressure (BP) \\<90 mmHg, maximum increase or decrease from baseline of \\>=30 mmHg; sitting diastolic BP \\<50 mmHg, maximum increase or decrease from baseline of \\>=20 mmHg. Baseline was defined as the last pre-dose measurement in Day 1. Only those categories in which at least 1 participant had data were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Post-Baseline Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo IV SAD', 'description': 'Participants received single dose of placebo on Day 1 as an intravenous (IV) infusion.'}, {'id': 'OG001', 'title': 'PF-06835375 0.03 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.'}, {'id': 'OG002', 'title': 'PF-06835375 0.1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.'}, {'id': 'OG003', 'title': 'PF-06835375 0.3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.'}, {'id': 'OG004', 'title': 'PF-06835375 1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.'}, {'id': 'OG005', 'title': 'PF-06835375 3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.'}, {'id': 'OG006', 'title': 'PF-06835375 6 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.'}, {'id': 'OG007', 'title': 'Placebo SC MAD', 'description': 'Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG008', 'title': 'PF-06835375 0.3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG009', 'title': 'PF-06835375 1 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG010', 'title': 'PF-06835375 3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG011', 'title': 'PF-06835375 6 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG012', 'title': 'PF-06835375 10 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}], 'classes': [{'title': 'Maximum QRS (ms) >=140', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': '450<= Maximum QTcB Interval (ms) <480', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}]}]}, {'title': '480<= Maximum QTcB Interval (ms) <500', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': 'Maximum QTcB Interval (ms) >=500', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': '30<= QTcB Maximum Increase From Baseline (ms) <60', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '3', 'groupId': 'OG012'}]}]}, {'title': '450<= Maximum QTcF Interval (ms) <480', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': '30<= QTcF Maximum Increase From Baseline (ms) <60', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}, {'title': '480<= Maximum QTcF Interval (ms) <500', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline up to end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)', 'description': "ECG abnormalities criteria included: 1) maximum QTc interval (ms): 450\\<= QTc \\<480, 480\\<= QTc \\<500, and QTc \\>=500; QTc maximum increase from baseline (ms): 30\\<= change \\<60, and change \\>=60; 2) maximum PR interval (ms): \\>=300; PR increase from baseline (ms): baseline \\>200 with 25% increase at maximum, baseline \\<=200 with 50% increase at maximum; 3) maximum QRS (ms): \\>=140; QRS increase from baseline (ms) \\>=50%. QTcF indicates QT interval corrected using the Fridericia's formula. QTcB indicates QT interval corrected using the Bazett's formula. Baseline was defined as the average of the triplicate pre-dose recordings at Day 1. Only those categories in which at least 1 participant had data were reported.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With All-Causality and Treatment-Related Infections and Infestations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo IV SAD', 'description': 'Participants received single dose of placebo on Day 1 as an intravenous (IV) infusion.'}, {'id': 'OG001', 'title': 'PF-06835375 0.03 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.'}, {'id': 'OG002', 'title': 'PF-06835375 0.1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.'}, {'id': 'OG003', 'title': 'PF-06835375 0.3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.'}, {'id': 'OG004', 'title': 'PF-06835375 1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.'}, {'id': 'OG005', 'title': 'PF-06835375 3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.'}, {'id': 'OG006', 'title': 'PF-06835375 6 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.'}, {'id': 'OG007', 'title': 'Placebo SC MAD', 'description': 'Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG008', 'title': 'PF-06835375 0.3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG009', 'title': 'PF-06835375 1 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG010', 'title': 'PF-06835375 3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG011', 'title': 'PF-06835375 6 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG012', 'title': 'PF-06835375 10 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}], 'classes': [{'title': 'Number of Participants with all-causality Infections and Infestations', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '2', 'groupId': 'OG012'}]}]}, {'title': 'Number of Participants with treatment-related Infections and Infestations', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator. The incidence of AEs by system organ class "infections and infestations" was reported here.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'B Cell Maximum Decrease (%) From Baseline Over Time Following Single and Multiple Doses of PF-06835375', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo IV SAD', 'description': 'Participants received single dose of placebo on Day 1 as an intravenous (IV) infusion.'}, {'id': 'OG001', 'title': 'PF-06835375 0.03 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.'}, {'id': 'OG002', 'title': 'PF-06835375 0.1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.'}, {'id': 'OG003', 'title': 'PF-06835375 0.3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.'}, {'id': 'OG004', 'title': 'PF-06835375 1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.'}, {'id': 'OG005', 'title': 'PF-06835375 3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.'}, {'id': 'OG006', 'title': 'PF-06835375 6 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.'}, {'id': 'OG007', 'title': 'Placebo SC MAD', 'description': 'Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG008', 'title': 'PF-06835375 0.3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG009', 'title': 'PF-06835375 1 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG010', 'title': 'PF-06835375 3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG011', 'title': 'PF-06835375 6 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG012', 'title': 'PF-06835375 10 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.693', 'spread': '43.0477', 'groupId': 'OG000'}, {'value': '67.283', 'spread': '29.3555', 'groupId': 'OG001'}, {'value': '84.978', 'spread': '5.9053', 'groupId': 'OG002'}, {'value': '94.052', 'spread': '2.4246', 'groupId': 'OG003'}, {'value': '98.546', 'spread': '0.1627', 'groupId': 'OG004'}, {'value': '98.588', 'spread': '1.0295', 'groupId': 'OG005'}, {'value': '99.326', 'spread': '0.3272', 'groupId': 'OG006'}, {'value': '41.854', 'spread': '52.5341', 'groupId': 'OG007'}, {'value': '91.056', 'spread': '12.6425', 'groupId': 'OG008'}, {'value': '99.650', 'spread': '0.4036', 'groupId': 'OG009'}, {'value': '99.287', 'spread': '0.6300', 'groupId': 'OG010'}, {'value': '99.278', 'spread': '1.4476', 'groupId': 'OG011'}, {'value': '99.134', 'spread': '0.9983', 'groupId': 'OG012'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Screening, Day 1, 2, 4, 8, 15, 29, 36 (Part B only), 43, 57, 85, 113, and every 4 weeks until criteria for end of study met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)', 'description': 'Blood samples for the assessment of B cell were collected and analyzed by flow cytometry. Baseline was defined as the average of screening and pre-dose measures.', 'unitOfMeasure': 'Percentage of decrease from baseline', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement.'}, {'type': 'SECONDARY', 'title': 'cTfh Cell Depletion Maximum Decrease (%) From Baseline Over Time Following Single and Multiple Doses of PF-06835375', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '7', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '6', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo IV SAD', 'description': 'Participants received single dose of placebo on Day 1 as an intravenous (IV) infusion.'}, {'id': 'OG001', 'title': 'PF-06835375 0.03 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.'}, {'id': 'OG002', 'title': 'PF-06835375 0.1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.'}, {'id': 'OG003', 'title': 'PF-06835375 0.3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.'}, {'id': 'OG004', 'title': 'PF-06835375 1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.'}, {'id': 'OG005', 'title': 'PF-06835375 3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.'}, {'id': 'OG006', 'title': 'PF-06835375 6 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.'}, {'id': 'OG007', 'title': 'Placebo SC MAD', 'description': 'Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG008', 'title': 'PF-06835375 0.3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG009', 'title': 'PF-06835375 1 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG010', 'title': 'PF-06835375 3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG011', 'title': 'PF-06835375 6 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG012', 'title': 'PF-06835375 10 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.227', 'spread': '48.6385', 'groupId': 'OG000'}, {'value': '62.360', 'spread': '23.1206', 'groupId': 'OG001'}, {'value': '84.994', 'spread': '11.2007', 'groupId': 'OG002'}, {'value': '89.324', 'spread': '6.3399', 'groupId': 'OG003'}, {'value': '98.675', 'spread': '1.2762', 'groupId': 'OG004'}, {'value': '97.283', 'spread': '3.0481', 'groupId': 'OG005'}, {'value': '97.789', 'spread': '3.1257', 'groupId': 'OG006'}, {'value': '58.116', 'spread': '52.5069', 'groupId': 'OG007'}, {'value': '89.540', 'spread': '14.8599', 'groupId': 'OG008'}, {'value': '95.442', 'spread': '5.3905', 'groupId': 'OG009'}, {'value': '96.683', 'spread': '1.8503', 'groupId': 'OG010'}, {'value': '97.721', 'spread': '1.6523', 'groupId': 'OG011'}, {'value': '98.118', 'spread': '0.8825', 'groupId': 'OG012'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Screening, Day 1, 2, 4, 8, 15, 29, 36 (Part B only), 43, 57, 85, 113, and every 4 weeks until criteria for end of study met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)', 'description': 'Blood samples for the assessment of circulating follicular T helper like (cTfh) cell were collected and analyzed by flow cytometry. Baseline was defined as the average of screening and pre-dose measures.', 'unitOfMeasure': 'Percentage of decrease from baseline', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Serum Concentration (Cmax) of PF-06835375 in Part A (SAD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06835375 0.03 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.'}, {'id': 'OG001', 'title': 'PF-06835375 0.1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.'}, {'id': 'OG002', 'title': 'PF-06835375 0.3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.'}, {'id': 'OG003', 'title': 'PF-06835375 1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.'}, {'id': 'OG004', 'title': 'PF-06835375 3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.'}, {'id': 'OG005', 'title': 'PF-06835375 6 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.', 'groupId': 'OG001'}, {'value': '103.0', 'spread': '197', 'groupId': 'OG002'}, {'value': '208.7', 'spread': '28', 'groupId': 'OG003'}, {'value': '994.7', 'spread': '29', 'groupId': 'OG004'}, {'value': '2645', 'spread': '13', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8, 15, 29, 43, 57, 85, 113 and 141 for Day 1 PK estimates', 'description': 'Cmax is maximum observed serum concentration. Cmax for PF-06835375 was observed directly from data.', 'unitOfMeasure': 'nanogram/milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants treated who had at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Cmax (Tmax) of PF-06835375 in Part A (SAD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06835375 0.03 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.'}, {'id': 'OG001', 'title': 'PF-06835375 0.1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.'}, {'id': 'OG002', 'title': 'PF-06835375 0.3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.'}, {'id': 'OG003', 'title': 'PF-06835375 1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.'}, {'id': 'OG004', 'title': 'PF-06835375 3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.'}, {'id': 'OG005', 'title': 'PF-06835375 6 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.17', 'groupId': 'OG002', 'lowerLimit': '2.15', 'upperLimit': '2.20'}, {'value': '2.08', 'groupId': 'OG003', 'lowerLimit': '2.07', 'upperLimit': '4.15'}, {'value': '2.24', 'groupId': 'OG004', 'lowerLimit': '2.17', 'upperLimit': '4.12'}, {'value': '3.96', 'groupId': 'OG005', 'lowerLimit': '2.00', 'upperLimit': '8.12'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8, 15, 29, 43, 57, 85, 113 and 141 for Day 1 PK estimates', 'description': 'Tmax is the time for Cmax. Tmax for PF-06835375 was observed directly from data as time of first occurrence.', 'unitOfMeasure': 'hour (hr)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants treated who had at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-06835375 in Part A (SAD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06835375 0.03 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.'}, {'id': 'OG001', 'title': 'PF-06835375 0.1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.'}, {'id': 'OG002', 'title': 'PF-06835375 0.3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.'}, {'id': 'OG003', 'title': 'PF-06835375 1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.'}, {'id': 'OG004', 'title': 'PF-06835375 3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.'}, {'id': 'OG005', 'title': 'PF-06835375 6 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.', 'groupId': 'OG000'}, {'value': '1573', 'spread': '2409', 'groupId': 'OG002'}, {'value': '7467', 'spread': '84', 'groupId': 'OG003'}, {'value': '88190', 'spread': '35', 'groupId': 'OG004'}, {'value': '288000', 'spread': '30', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8, 15, 29, 43, 57, 85, 113 and 141 for Day 1 PK estimates', 'description': 'AUCinf is the area under the serum concentration-time profile from time zero extrapolated to infinite time.', 'unitOfMeasure': 'nanogram*hour/milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants treated who had at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06835375 in Part A (SAD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06835375 0.03 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.'}, {'id': 'OG001', 'title': 'PF-06835375 0.1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.'}, {'id': 'OG002', 'title': 'PF-06835375 0.3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.'}, {'id': 'OG003', 'title': 'PF-06835375 1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.'}, {'id': 'OG004', 'title': 'PF-06835375 3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.'}, {'id': 'OG005', 'title': 'PF-06835375 6 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.', 'groupId': 'OG001'}, {'value': '1380', 'spread': '2950', 'groupId': 'OG002'}, {'value': '7327', 'spread': '85', 'groupId': 'OG003'}, {'value': '87120', 'spread': '36', 'groupId': 'OG004'}, {'value': '287400', 'spread': '30', 'groupId': 'OG005'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8, 15, 29, 43, 57, 85, 113 and 141 for Day 1 PK estimates', 'description': 'AUClast is the area under the curve from time zero to last quantifiable concentration. AUClast for PF-06835375 was determined using linear/log trapezoidal method.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants treated who had at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Cmax of PF-06835375 Following First Dose and Multiple Doses in Part B (MAD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06835375 1 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG001', 'title': 'PF-06835375 3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG002', 'title': 'PF-06835375 6 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG003', 'title': 'PF-06835375 10 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.743', 'spread': '148', 'groupId': 'OG000'}, {'value': '34.82', 'spread': '79', 'groupId': 'OG001'}, {'value': '77.72', 'spread': '150', 'groupId': 'OG002'}, {'value': '257.8', 'spread': '204', 'groupId': 'OG003'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '26.92', 'spread': '68', 'groupId': 'OG000'}, {'value': '89.68', 'spread': '93', 'groupId': 'OG001'}, {'value': '209.6', 'spread': '115', 'groupId': 'OG002'}, {'value': '262.1', 'spread': '224', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8 and 15 for Day 1 PK estimates; Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates', 'description': 'Cmax is maximum observed serum concentration. Cmax for PF-06835375 was observed directly from data. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants treated who had at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Tmax of PF-06835375 Following First Dose and Multiple Doses in Part B (MAD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06835375 1 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG001', 'title': 'PF-06835375 3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG002', 'title': 'PF-06835375 6 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG003', 'title': 'PF-06835375 10 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '170', 'groupId': 'OG000', 'lowerLimit': '67.4', 'upperLimit': '170'}, {'value': '168', 'groupId': 'OG001', 'lowerLimit': '72.7', 'upperLimit': '361'}, {'value': '169', 'groupId': 'OG002', 'lowerLimit': '73.3', 'upperLimit': '192'}, {'value': '144', 'groupId': 'OG003', 'lowerLimit': '47.7', 'upperLimit': '172'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000', 'lowerLimit': '168', 'upperLimit': '169'}, {'value': '169', 'groupId': 'OG001', 'lowerLimit': '123', 'upperLimit': '337'}, {'value': '171', 'groupId': 'OG002', 'lowerLimit': '120', 'upperLimit': '336'}, {'value': '121', 'groupId': 'OG003', 'lowerLimit': '7.55', 'upperLimit': '169'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8 and 15 for Day 1 PK estimates; Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates', 'description': 'Tmax is the time for Cmax. Tmax for PF-06835375 was observed directly from data as time of first occurrence. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants treated who had at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06835375 Following First Dose and Multiple Doses in Part B (MAD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06835375 1 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG001', 'title': 'PF-06835375 3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG002', 'title': 'PF-06835375 6 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG003', 'title': 'PF-06835375 10 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1964', 'spread': '130', 'groupId': 'OG000'}, {'value': '11010', 'spread': '84', 'groupId': 'OG001'}, {'value': '28070', 'spread': '251', 'groupId': 'OG002'}, {'value': '70630', 'spread': '202', 'groupId': 'OG003'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9309', 'spread': '62', 'groupId': 'OG000'}, {'value': '25610', 'spread': '125', 'groupId': 'OG001'}, {'value': '76450', 'spread': '142', 'groupId': 'OG002'}, {'value': '88540', 'spread': '154', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8 and 15 for Day 1 PK estimates; Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates', 'description': 'AUCtau is area under the serum concentration-time profile from time 0 to time tau, the dosing interval, where tau= 28 days. AUCtau for PF-06835375 was determined using linear/log trapezoidal method. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants treated who had at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'AUClast of PF-06835375 Following Multiple Doses in Part B (MAD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06835375 1 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG001', 'title': 'PF-06835375 3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG002', 'title': 'PF-06835375 6 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG003', 'title': 'PF-06835375 10 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}], 'classes': [{'categories': [{'measurements': [{'value': '9346', 'spread': '61', 'groupId': 'OG000'}, {'value': '22050', 'spread': '146', 'groupId': 'OG001'}, {'value': '84370', 'spread': '160', 'groupId': 'OG002'}, {'value': '96610', 'spread': '141', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates', 'description': 'AUClast is the area under the curve from time zero to last quantifiable concentration. AUClast for PF-06835375 was determined using linear/log trapezoidal method. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants treated who had at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Minimum Observed Serum Trough Concentration (Cmin) of PF-06835375 Following Multiple Doses in Part B (MAD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06835375 1 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG001', 'title': 'PF-06835375 3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG002', 'title': 'PF-06835375 6 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG003', 'title': 'PF-06835375 10 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated', 'groupId': 'OG000'}, {'value': '6.075', 'spread': '80', 'groupId': 'OG001'}, {'value': '11.81', 'spread': '434', 'groupId': 'OG002'}, {'value': '9.410', 'spread': '199', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates', 'description': 'Cmin is minimum observed serum trough concentration. Cmin was observed directly from data. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants treated who had at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Observed Accumulation Ratio (Rac) of PF-06835375 Following Multiple Doses in Part B (MAD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06835375 1 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG001', 'title': 'PF-06835375 3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG002', 'title': 'PF-06835375 6 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG003', 'title': 'PF-06835375 10 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.', 'groupId': 'OG000'}, {'value': '2.410', 'spread': '74', 'groupId': 'OG001'}, {'value': '2.977', 'spread': '79', 'groupId': 'OG002'}, {'value': '2.001', 'spread': '209', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8 and 15 for Day 1 PK estimates; Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates', 'description': 'Rac is observed accumulation ratio. Rac = Day 29 AUCtau / Day 1 AUCtau. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants treated who had at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Peak-to-trough Fluctuation (PTF) of PF-06835375 Following Multiple Doses in Part B (MAD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06835375 1 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG001', 'title': 'PF-06835375 3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG002', 'title': 'PF-06835375 6 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG003', 'title': 'PF-06835375 10 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'NA indicates not calculable. There were insufficient number of participants with reportable parameter values (less than 3), so these summary statistics were not calculated.', 'groupId': 'OG000'}, {'value': '2.037', 'spread': '26', 'groupId': 'OG001'}, {'value': '1.687', 'spread': '31', 'groupId': 'OG002'}, {'value': '1.830', 'spread': '35', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates', 'description': 'PTF is peak-to-trough fluctuation at steady state. PTF = (Cmax-Cmin)/Cav. Cav is average serum concentration. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants treated who had at least 1 of the PK parameters of interest.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) Against PF-06835375', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '7', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-06835375 0.03 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.'}, {'id': 'OG001', 'title': 'PF-06835375 0.1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.'}, {'id': 'OG002', 'title': 'PF-06835375 0.3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.'}, {'id': 'OG003', 'title': 'PF-06835375 1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.'}, {'id': 'OG004', 'title': 'PF-06835375 3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.'}, {'id': 'OG005', 'title': 'PF-06835375 6 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.'}, {'id': 'OG006', 'title': 'PF-06835375 0.3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG007', 'title': 'PF-06835375 1 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG008', 'title': 'PF-06835375 3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG009', 'title': 'PF-06835375 6 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'OG010', 'title': 'PF-06835375 10 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}], 'classes': [{'title': 'Number of ADA or NAb evaluable participants with positive ADA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}]}]}, {'title': 'Number of ADA or NAb evaluable participants with positive NAb', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1, 15, 29, 43, 57, 85, 113, and every 4 weeks until criteria for end of study met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)', 'description': 'To evaluate the immunogenicity as measured by presence of ADA and NAb in participants treated with PF-06835375.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least 1 dose of study treatment and had at least 1 pharmacodynamic measurement.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo IV SAD', 'description': 'Participants received single dose of placebo on Day 1 as an intravenous (IV) infusion.'}, {'id': 'FG001', 'title': 'PF-06835375 0.03 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.'}, {'id': 'FG002', 'title': 'PF-06835375 0.1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.'}, {'id': 'FG003', 'title': 'PF-06835375 0.3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.'}, {'id': 'FG004', 'title': 'PF-06835375 1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.'}, {'id': 'FG005', 'title': 'PF-06835375 3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.'}, {'id': 'FG006', 'title': 'PF-06835375 6 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.'}, {'id': 'FG007', 'title': 'Placebo SC MAD', 'description': 'Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'FG008', 'title': 'PF-06835375 0.3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'FG009', 'title': 'PF-06835375 1 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'FG010', 'title': 'PF-06835375 3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'FG011', 'title': 'PF-06835375 6 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'FG012', 'title': 'PF-06835375 10 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '11'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '7'}, {'groupId': 'FG011', 'numSubjects': '6'}, {'groupId': 'FG012', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '9'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '5'}, {'groupId': 'FG012', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': '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': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '2'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'This study included two parts: Part A, consisting of 7 single ascending dose (SAD) cohorts (placebo and PF-06835375 0.03 mg, 0.1 mg, 0.3 mg, 1 mg, 3 mg, 6 mg); and Part B, consisting 6 multiple ascending dose (MAD) cohorts (placebo and PF-06835375 0.3 mg, 1 mg, 3 mg, 6 mg, 10 mg). In Part A (SAD), 32 participants were assigned to treatment, 1 of whom was not treated. In Part B (MAD), 42 participants were screened and treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '11', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '7', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '6', 'groupId': 'BG012'}, {'value': '73', 'groupId': 'BG013'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo IV SAD', 'description': 'Participants received single dose of placebo on Day 1 as an intravenous (IV) infusion.'}, {'id': 'BG001', 'title': 'PF-06835375 0.03 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.03 mg on Day 1 as an IV infusion.'}, {'id': 'BG002', 'title': 'PF-06835375 0.1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.1 mg on Day 1 as an IV infusion.'}, {'id': 'BG003', 'title': 'PF-06835375 0.3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 0.3 mg on Day 1 as an IV infusion.'}, {'id': 'BG004', 'title': 'PF-06835375 1 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 1 mg on Day 1 as an IV infusion.'}, {'id': 'BG005', 'title': 'PF-06835375 3 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 3 mg on Day 1 as an IV infusion.'}, {'id': 'BG006', 'title': 'PF-06835375 6 mg IV SAD', 'description': 'Participants received single dose of PF-06835375 6 mg on Day 1 as an IV infusion.'}, {'id': 'BG007', 'title': 'Placebo SC MAD', 'description': 'Participants received two doses of placebo subcutaneously (SC) with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'BG008', 'title': 'PF-06835375 0.3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 0.3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'BG009', 'title': 'PF-06835375 1 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 1 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'BG010', 'title': 'PF-06835375 3 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 3 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'BG011', 'title': 'PF-06835375 6 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 6 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'BG012', 'title': 'PF-06835375 10 mg SC MAD', 'description': 'Participants received two doses of PF-06835375 10 mg SC with first dose on Day 1 and the repeated dose on Day 29.'}, {'id': 'BG013', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.00', 'spread': '11.58', 'groupId': 'BG000'}, {'value': '53.33', 'spread': '11.02', 'groupId': 'BG001'}, {'value': '47.33', 'spread': '15.53', 'groupId': 'BG002'}, {'value': '57.33', 'spread': '6.03', 'groupId': 'BG003'}, {'value': '54.00', 'spread': '10.15', 'groupId': 'BG004'}, {'value': '52.33', 'spread': '13.95', 'groupId': 'BG005'}, {'value': '54.00', 'spread': '5.66', 'groupId': 'BG006'}, {'value': '48.64', 'spread': '13.60', 'groupId': 'BG007'}, {'value': '52.00', 'spread': '10.56', 'groupId': 'BG008'}, {'value': '54.17', 'spread': '7.70', 'groupId': 'BG009'}, {'value': '53.57', 'spread': '8.20', 'groupId': 'BG010'}, {'value': '61.67', 'spread': '10.80', 'groupId': 'BG011'}, {'value': '58.50', 'spread': '9.25', 'groupId': 'BG012'}, {'value': '53.26', 'spread': '10.71', 'groupId': 'BG013'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<18', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}]}]}, {'title': '18-44', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '15', 'groupId': 'BG013'}]}]}, {'title': '45-64', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '5', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '3', 'groupId': 'BG012'}, {'value': '48', 'groupId': 'BG013'}]}]}, {'title': '>=65', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}, {'value': '10', 'groupId': 'BG013'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '11', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '7', 'groupId': 'BG010'}, {'value': '5', 'groupId': 'BG011'}, {'value': '4', 'groupId': 'BG012'}, {'value': '65', 'groupId': 'BG013'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '2', 'groupId': 'BG012'}, {'value': '8', 'groupId': 'BG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '10', 'groupId': 'BG013'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '5', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '6', 'groupId': 'BG012'}, {'value': '63', 'groupId': 'BG013'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '1', 'groupId': 'BG012'}, {'value': '15', 'groupId': 'BG013'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '4', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}, {'value': '5', 'groupId': 'BG011'}, {'value': '5', 'groupId': 'BG012'}, {'value': '54', 'groupId': 'BG013'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '1', 'groupId': 'BG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline analysis population included all enrolled participants who received at least one dose of study treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-09', 'size': 8768437, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-01-10T12:37', 'hasProtocol': True}, {'date': '2022-01-14', 'size': 3619582, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-01-10T12:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-10', 'studyFirstSubmitDate': '2017-11-03', 'resultsFirstSubmitDate': '2023-01-10', 'studyFirstSubmitQcDate': '2017-11-03', 'lastUpdatePostDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-10', 'studyFirstPostDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Dose-Limiting Toxicity (DLT)', 'timeFrame': 'From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)', 'description': 'DLT was defined as any of the following events meeting the criteria: (1) \\>=2 participants within a dose cohort developed Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grade 3 adverse event considered to be serious in the same organ system or 1 participant developed a CTCAE v4.0 Grade 4 or higher SAE considered related to study drug; (2) 50% or more participants within a dose cohort experienced a CTCAE v4.0 Grade 3 or higher infusion reaction; (3) a confirmed or probable case of Progressive Multifocal Leukoencephalopathy was observed; (4) the mean exposure for the treatment group reached or exceeded the exposure stopping limit of Cav of 261 mg/mL, or, based on the observed data, the group mean Cav of the next planned dose was projected to exceed the exposure stopping limit. Cav = average serum concentration.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) by Severity', 'timeFrame': 'From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)', 'description': "An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator. Treatment-emergent were events between first dose of study drug and up to approximately Week 40 that were absent before treatment or that worsened relative to pretreatment state. AEs are classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function."}, {'measure': 'Number of Participants With All-Causality and Treatment-Related TEAEs', 'timeFrame': 'From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to approximately Week 40 that were absent before treatment or that worsened relative to pretreatment state.'}, {'measure': 'Number of Participants With Permanent Discontinuation Due to TEAEs', 'timeFrame': 'From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)', 'description': 'An AE was 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 approximately Week 40 that were absent before treatment or that worsened relative to pretreatment state.'}, {'measure': 'Number of Participants With Clinically Significant Laboratory Abnormalities in Hematology, Chemistry, and Urinalysis', 'timeFrame': 'From baseline up to end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)', 'description': 'Hematology included hemoglobin, hematocrit, red blood cell, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet and white blood cell count, total neutrophils, eosinophils, monocytes, basophils and lymphocytes. Chemistry included blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein and creatine kinase. Urinalysis included pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy and creatinine. Clinical significance was judged by the investigator and those met the criteria of AE are listed here. Clinically significant laboratory abnormalities reported for at least 1 participant in the whole study are presented here. Baseline was the last pre-dose measurement (first treatment for MAD cohorts).'}, {'measure': 'Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria', 'timeFrame': 'From baseline up to end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)', 'description': 'Criteria for abnormality in vital signs: supine pulse rate \\<40 beats per minute (bpm) or \\>120 bpm; standing pulse rate \\<40 bpm or \\>120 bpm; sitting systolic blood pressure (BP) \\<90 mmHg, maximum increase or decrease from baseline of \\>=30 mmHg; sitting diastolic BP \\<50 mmHg, maximum increase or decrease from baseline of \\>=20 mmHg. Baseline was defined as the last pre-dose measurement in Day 1. Only those categories in which at least 1 participant had data were reported.'}, {'measure': 'Number of Participants With Post-Baseline Electrocardiogram (ECG) Data Meeting Categorical Summarization Criteria', 'timeFrame': 'From baseline up to end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)', 'description': "ECG abnormalities criteria included: 1) maximum QTc interval (ms): 450\\<= QTc \\<480, 480\\<= QTc \\<500, and QTc \\>=500; QTc maximum increase from baseline (ms): 30\\<= change \\<60, and change \\>=60; 2) maximum PR interval (ms): \\>=300; PR increase from baseline (ms): baseline \\>200 with 25% increase at maximum, baseline \\<=200 with 50% increase at maximum; 3) maximum QRS (ms): \\>=140; QRS increase from baseline (ms) \\>=50%. QTcF indicates QT interval corrected using the Fridericia's formula. QTcB indicates QT interval corrected using the Bazett's formula. Baseline was defined as the average of the triplicate pre-dose recordings at Day 1. Only those categories in which at least 1 participant had data were reported."}, {'measure': 'Number of Participants With All-Causality and Treatment-Related Infections and Infestations', 'timeFrame': 'From the first dose of study treatment up to 7-14 days after end of study criteria met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Relatedness to study drug was assessed by the investigator. The incidence of AEs by system organ class "infections and infestations" was reported here.'}], 'secondaryOutcomes': [{'measure': 'B Cell Maximum Decrease (%) From Baseline Over Time Following Single and Multiple Doses of PF-06835375', 'timeFrame': 'Screening, Day 1, 2, 4, 8, 15, 29, 36 (Part B only), 43, 57, 85, 113, and every 4 weeks until criteria for end of study met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)', 'description': 'Blood samples for the assessment of B cell were collected and analyzed by flow cytometry. Baseline was defined as the average of screening and pre-dose measures.'}, {'measure': 'cTfh Cell Depletion Maximum Decrease (%) From Baseline Over Time Following Single and Multiple Doses of PF-06835375', 'timeFrame': 'Screening, Day 1, 2, 4, 8, 15, 29, 36 (Part B only), 43, 57, 85, 113, and every 4 weeks until criteria for end of study met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)', 'description': 'Blood samples for the assessment of circulating follicular T helper like (cTfh) cell were collected and analyzed by flow cytometry. Baseline was defined as the average of screening and pre-dose measures.'}, {'measure': 'Maximum Observed Serum Concentration (Cmax) of PF-06835375 in Part A (SAD)', 'timeFrame': 'Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8, 15, 29, 43, 57, 85, 113 and 141 for Day 1 PK estimates', 'description': 'Cmax is maximum observed serum concentration. Cmax for PF-06835375 was observed directly from data.'}, {'measure': 'Time to Reach Cmax (Tmax) of PF-06835375 in Part A (SAD)', 'timeFrame': 'Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8, 15, 29, 43, 57, 85, 113 and 141 for Day 1 PK estimates', 'description': 'Tmax is the time for Cmax. Tmax for PF-06835375 was observed directly from data as time of first occurrence.'}, {'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-06835375 in Part A (SAD)', 'timeFrame': 'Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8, 15, 29, 43, 57, 85, 113 and 141 for Day 1 PK estimates', 'description': 'AUCinf is the area under the serum concentration-time profile from time zero extrapolated to infinite time.'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06835375 in Part A (SAD)', 'timeFrame': 'Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8, 15, 29, 43, 57, 85, 113 and 141 for Day 1 PK estimates', 'description': 'AUClast is the area under the curve from time zero to last quantifiable concentration. AUClast for PF-06835375 was determined using linear/log trapezoidal method.'}, {'measure': 'Cmax of PF-06835375 Following First Dose and Multiple Doses in Part B (MAD)', 'timeFrame': 'Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8 and 15 for Day 1 PK estimates; Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates', 'description': 'Cmax is maximum observed serum concentration. Cmax for PF-06835375 was observed directly from data. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated.'}, {'measure': 'Tmax of PF-06835375 Following First Dose and Multiple Doses in Part B (MAD)', 'timeFrame': 'Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8 and 15 for Day 1 PK estimates; Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates', 'description': 'Tmax is the time for Cmax. Tmax for PF-06835375 was observed directly from data as time of first occurrence. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated.'}, {'measure': 'Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06835375 Following First Dose and Multiple Doses in Part B (MAD)', 'timeFrame': 'Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8 and 15 for Day 1 PK estimates; Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates', 'description': 'AUCtau is area under the serum concentration-time profile from time 0 to time tau, the dosing interval, where tau= 28 days. AUCtau for PF-06835375 was determined using linear/log trapezoidal method. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated.'}, {'measure': 'AUClast of PF-06835375 Following Multiple Doses in Part B (MAD)', 'timeFrame': 'Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates', 'description': 'AUClast is the area under the curve from time zero to last quantifiable concentration. AUClast for PF-06835375 was determined using linear/log trapezoidal method. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated.'}, {'measure': 'Minimum Observed Serum Trough Concentration (Cmin) of PF-06835375 Following Multiple Doses in Part B (MAD)', 'timeFrame': 'Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates', 'description': 'Cmin is minimum observed serum trough concentration. Cmin was observed directly from data. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated.'}, {'measure': 'Observed Accumulation Ratio (Rac) of PF-06835375 Following Multiple Doses in Part B (MAD)', 'timeFrame': 'Day 1 (pre-dose, 2, 4, 6, 8, 12 hours post dose), 2, 4, 8 and 15 for Day 1 PK estimates; Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates', 'description': 'Rac is observed accumulation ratio. Rac = Day 29 AUCtau / Day 1 AUCtau. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated.'}, {'measure': 'Peak-to-trough Fluctuation (PTF) of PF-06835375 Following Multiple Doses in Part B (MAD)', 'timeFrame': 'Day 29 (pre-dose, 2, 4, 6, 8, hours post dose), 36, 43, 57, 85 and 113 for Day 29 PK estimates', 'description': 'PTF is peak-to-trough fluctuation at steady state. PTF = (Cmax-Cmin)/Cav. Cav is average serum concentration. There were less than 3 quantifiable concentrations for participants in PF-06835375 0.3 mg SC MAD cohort, therefore the serum PK parameters were not calculated.'}, {'measure': 'Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) Against PF-06835375', 'timeFrame': 'Day 1, 15, 29, 43, 57, 85, 113, and every 4 weeks until criteria for end of study met (maximum duration for end of study criteria met: Day 225 for Part A, Day 281 for Part B)', 'description': 'To evaluate the immunogenicity as measured by presence of ADA and NAb in participants treated with PF-06835375.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Lupus Erythematosus', 'Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '38845046', 'type': 'DERIVED', 'citation': 'Cohen S, Beebe JS, Chindalore V, Guan S, Hassan-Zahraee M, Saxena M, Xi L, Hyde C, Koride S, Levin R, Lubaczewski S, Salganik M, Sloan A, Stevens E, Peeva E, Vincent MS, Martin DA, Chu M. A Phase 1, randomized, double-blind, placebo-controlled, single- and multiple-dose escalation study to evaluate the safety and pharmacokinetics/pharmacodynamics of PF-06835375, a C-X-C chemokine receptor type 5 directed antibody, in patients with systemic lupus erythematosus or rheumatoid arthritis. Arthritis Res Ther. 2024 Jun 6;26(1):117. doi: 10.1186/s13075-024-03337-2.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C1131001', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 1 single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-06835375 in subjects with seropositive SLE or RA. The design is double-blind, sponsor open and placebo controlled. This study will include two parts: Part A and Part B. Part A will consist of single ascending dose cohorts, Part B of multiple ascending dose cohorts. This study will enroll up to a total of approximately 112 subjects at approximately 10 sites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Rheumatoid Arthritis: confirmed diagnosis according to 2010 ACR/EULAR criteria with symptom duration at least 6 months and positive with Rheumatoid Factor and/or anti citrullinated peptide antibody\n* Patients with Systemic Lupus Erythematosus: Confirmed diagnosis according to the SLICC Classification Criteria with symptom duration at least 6 months and at least one of the following: positive antinuclear antibody titer, positive anti-dsDNA, anti-Smith antibodies\n\nExclusion Criteria:\n\n* Active central nervous system manifestations, systemic vasculitis or pleuro/pericarditis\n* Active lupus nephritis\n* Treatment with B cell depleting agents within 52 weeks prior to screening'}, 'identificationModule': {'nctId': 'NCT03334851', 'briefTitle': 'Safety and Tolerability Study Of PF-06835375 In Subjects With Seropositive Systemic Lupus Erythematosus Or Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 1, RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE DOSE-ESCALATION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-06835375 IN SUBJECTS WITH SEROPOSITIVE SYSTEMIC LUPUS ERYTHEMATOSUS OR RHEUMATOID ARTHRITIS', 'orgStudyIdInfo': {'id': 'C1131001'}, 'secondaryIdInfos': [{'id': '2017-003077-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A, Cohort 1', 'description': 'Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration', 'interventionNames': ['Drug: PF-06835375', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A, Cohort 2', 'description': 'Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.', 'interventionNames': ['Drug: PF-06835375', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A, Cohort 3', 'description': 'Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.', 'interventionNames': ['Drug: PF-06835375', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A, Cohort 4', 'description': 'Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.', 'interventionNames': ['Drug: PF-06835375', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A, Cohort 5', 'description': 'Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.', 'interventionNames': ['Drug: PF-06835375', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A, Cohort 6', 'description': 'Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.', 'interventionNames': ['Drug: PF-06835375', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A, Cohort 7', 'description': 'Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.', 'interventionNames': ['Drug: PF-06835375', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A, Cohort 8', 'description': 'Subjects will receive a single dose of PF-06835375 or placebo on Day 1 via intravenous administration.', 'interventionNames': ['Drug: PF-06835375', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B, Cohort 1', 'description': 'Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous administration.', 'interventionNames': ['Drug: PF-06835375', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B, Cohort 2', 'description': 'Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.', 'interventionNames': ['Drug: PF-06835375', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B, Cohort 3', 'description': 'Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.', 'interventionNames': ['Drug: PF-06835375', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B, Cohort 4', 'description': 'Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.', 'interventionNames': ['Drug: PF-06835375', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B, Cohort 5', 'description': 'Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.', 'interventionNames': ['Drug: PF-06835375', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B, cohort 6', 'description': 'Subjects will receive two doses of PF-06835375 or placebo on Day 1 and Day 29 via subcutaneous or intravenous administration.', 'interventionNames': ['Drug: PF-06835375', 'Drug: Placebo']}], 'interventions': [{'name': 'PF-06835375', 'type': 'DRUG', 'description': 'Intravenous (IV) or subcutaneous (SC) administration. Subjects will receive one or two doses. Doses will be ascending and determined by emerging data.', 'armGroupLabels': ['Part A, Cohort 1', 'Part A, Cohort 2', 'Part A, Cohort 3', 'Part A, Cohort 4', 'Part A, Cohort 5', 'Part A, Cohort 6', 'Part A, Cohort 7', 'Part A, Cohort 8', 'Part B, Cohort 1', 'Part B, Cohort 2', 'Part B, Cohort 3', 'Part B, Cohort 4', 'Part B, Cohort 5', 'Part B, cohort 6']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo for PF-06835375 IV or SC. Subjects will receive one or two doses.', 'armGroupLabels': ['Part A, Cohort 1', 'Part A, Cohort 2', 'Part A, Cohort 3', 'Part A, Cohort 4', 'Part A, Cohort 5', 'Part A, Cohort 6', 'Part A, Cohort 7', 'Part A, Cohort 8', 'Part B, Cohort 1', 'Part B, Cohort 2', 'Part B, Cohort 3', 'Part B, Cohort 4', 'Part B, Cohort 5', 'Part B, cohort 6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36201', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pinnacle Research Group, LLC', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pinnacle Research Group, LLC', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Wallace Rheumatic Studies Center', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Prive aftercare', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research of West Florida, Inc.', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Private Practice of Robert W. Levin, MD', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Avail Clinical Research', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '32808', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Omega Research Maitland, LLC', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Larkin Hospital', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Qps Mra, Llc', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Qps-Mra, Llc', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '21225', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'PAREXEL International - EPCU Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21228', 'city': 'Catonsville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Rheumatology Express', 'geoPoint': {'lat': 39.27205, 'lon': -76.73192}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Phase 1 Research, LLC', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Altoona Center for Clinical Research', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Metroplex Clinical Research Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'MPP Infusion Centers', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}