Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-27 @ 11:32 PM
Study NCT ID:
NCT04373460
Status:
COMPLETED
Last Update Posted:
2023-06-02
First Post:
2020-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Convalescent Plasma to Limit SARS-CoV-2 Associated Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093522', 'term': 'COVID-19 Serotherapy'}], 'ancestors': [{'id': 'D019264', 'term': 'Adoptive Transfer'}, {'id': 'D007116', 'term': 'Immunization, Passive'}, {'id': 'D007114', 'term': 'Immunization'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dsulliv7@jh.edu', 'phone': '410-502-2522', 'title': 'David J. Sullivan', 'organization': 'Johns Hopkins University Bloomberg School of Public Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '90 days', 'description': 'We have analyzed adverse event on the severity grade system 1 through 5, with grades 3-5 categorized as severe.', 'eventGroups': [{'id': 'EG000', 'title': 'SARS-CoV-2 Convalescent Plasma', 'description': 'SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.\n\nSARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.', 'otherNumAtRisk': 592, 'deathsNumAtRisk': 592, 'otherNumAffected': 106, 'seriousNumAtRisk': 592, 'deathsNumAffected': 0, 'seriousNumAffected': 34}, {'id': 'EG001', 'title': 'Standard Control Plasma', 'description': 'Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.\n\nPlasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.', 'otherNumAtRisk': 589, 'deathsNumAtRisk': 589, 'otherNumAffected': 109, 'seriousNumAtRisk': 589, 'deathsNumAffected': 3, 'seriousNumAffected': 55}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Lymph node pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Chest pain - cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Burning and itching eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Left Lower Eyelid Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Retinal tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Anal Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Esophageal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Edema limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Heavy chest pain feeling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Infusion site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Worsening Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Allergic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Post-vaccine reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Bladder infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Bronchial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Herpes simplex reactivation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Shingles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vaginal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Facial contusions secondary to assault', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Laceration of Forehead', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Alcohol intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hyperlipidemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Chest wall pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Muscle spasms in lower extremities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 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'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Transient ischemic attacks', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Twitch in lip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Renal calculi', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Urine 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[{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Laryngeal edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Erythema multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hyperkeratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Rash acneiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Skin ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Lymphedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Chest pain - cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Bronchial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Kidney Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 31, 'numAffected': 31}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vasovagal reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hallucinations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Renal calculi', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Sinus pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 592, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 589, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cumulative Number of Hospitalizations or Deaths Prior to Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '592', 'groupId': 'OG000'}, {'value': '589', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SARS-CoV-2 Convalescent Plasma', 'description': 'SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.\n\nSARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.'}, {'id': 'OG001', 'title': 'Standard Control Plasma', 'description': 'Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.\n\nPlasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.4', 'ciLowerLimit': '1.0', 'ciUpperLimit': '5.8', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to day 28', 'description': 'Cumulative Number measured as the proportion of subjects who were hospitalized or who died prior to hospitalization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes patients who were randomized and received transfusion'}, {'type': 'PRIMARY', 'title': 'Cumulative Incidence of Severe Infusion Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '592', 'groupId': 'OG000'}, {'value': '589', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SARS-CoV-2 Convalescent Plasma', 'description': 'SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.\n\nSARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.'}, {'id': 'OG001', 'title': 'Standard Control Plasma', 'description': 'Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.\n\nPlasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000'}, {'value': '0.00', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.02', 'statisticalMethod': 'Rate per person-years', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to day 28', 'description': 'Cumulative incidence measured as rate per person-years experiencing treatment-related severe infusion reactions during the study period.', 'unitOfMeasure': 'Rate per person-years', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes patients who were randomized and received transfusion'}, {'type': 'PRIMARY', 'title': 'Cumulative Incidence of Treatment-related Grade 3 or Higher Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '592', 'groupId': 'OG000'}, {'value': '589', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SARS-CoV-2 Convalescent Plasma', 'description': 'SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.\n\nSARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.'}, {'id': 'OG001', 'title': 'Standard Control Plasma', 'description': 'Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.\n\nPlasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000'}, {'value': '0.43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Incidence rate difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '0.03', 'ciUpperLimit': '0.32', 'statisticalMethod': 'Rate per person-years', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to day 90', 'description': 'Cumulative incidence measured as rate per person-years experiencing a Grade 3 or higher.', 'unitOfMeasure': 'Rate per person-years', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Cumulative Incidence of Treatment-related Acute Respiratory Distress Syndrome (ARDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '592', 'groupId': 'OG000'}, {'value': '589', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SARS-CoV-2 Convalescent Plasma', 'description': 'SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.\n\nSARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.'}, {'id': 'OG001', 'title': 'Standard Control Plasma', 'description': 'Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.\n\nPlasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}, {'value': '0.01', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.32', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.02', 'statisticalMethod': 'Rate per person-years', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to day 28', 'description': 'Cumulative incidence measured as rate per person-years of treatment-related severe Acute Respiratory Distress Syndrome (ARDS) during the study period.', 'unitOfMeasure': 'Rate per person-years', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes patients who were randomized and received transfusion'}, {'type': 'SECONDARY', 'title': 'Serum SARS-CoV-2 Antibody Titers by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '577', 'groupId': 'OG000'}, {'value': '564', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SARS-CoV-2 Convalescent Plasma', 'description': 'SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.\n\nSARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.'}, {'id': 'OG001', 'title': 'Standard Control Plasma', 'description': 'Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.\n\nPlasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.'}], 'classes': [{'title': 'Pre-transfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '577', 'groupId': 'OG000'}, {'value': '564', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '345', 'groupId': 'OG000', 'lowerLimit': '276', 'upperLimit': '431'}, {'value': '316', 'groupId': 'OG001', 'lowerLimit': '254', 'upperLimit': '393'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '553', 'groupId': 'OG000'}, {'value': '546', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8595', 'groupId': 'OG000', 'lowerLimit': '7211', 'upperLimit': '10245'}, {'value': '9868', 'groupId': 'OG001', 'lowerLimit': '8217', 'upperLimit': '11851'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '541', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10980', 'groupId': 'OG000', 'lowerLimit': '9196', 'upperLimit': '13111'}, {'value': '12241', 'groupId': 'OG001', 'lowerLimit': '10215', 'upperLimit': '14668'}]}]}, {'title': 'Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '529', 'groupId': 'OG000'}, {'value': '518', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13958', 'groupId': 'OG000', 'lowerLimit': '11577', 'upperLimit': '16829'}, {'value': '13281', 'groupId': 'OG001', 'lowerLimit': '10979', 'upperLimit': '16065'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 0, 14, 28 and 90', 'description': 'Geometric mean Spike Receptor Binding Domain (RBD) titers at day 0, 14, 28 and 90 between the randomized arms.', 'unitOfMeasure': 'Spike Receptor Binding Domain Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis limited to those that were transfused and had the titer data performed'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With ICU Admission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '592', 'groupId': 'OG000'}, {'value': '589', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SARS-CoV-2 Convalescent Plasma', 'description': 'SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.\n\nSARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.'}, {'id': 'OG001', 'title': 'Standard Control Plasma', 'description': 'Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.\n\nPlasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.'}], 'classes': [{'categories': [{'title': 'Admission to ICU', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'No admission to ICU', 'measurements': [{'value': '589', 'groupId': 'OG000'}, {'value': '582', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to day 90', 'description': 'Disease severity measured by admission to the ICU', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes patients who were randomized and received transfusion'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Invasive Mechanical Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '592', 'groupId': 'OG000'}, {'value': '589', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SARS-CoV-2 Convalescent Plasma', 'description': 'SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.\n\nSARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.'}, {'id': 'OG001', 'title': 'Standard Control Plasma', 'description': 'Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.\n\nPlasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.'}], 'classes': [{'categories': [{'title': 'On invasive mechanical ventilation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'No invasive mechanical ventilation', 'measurements': [{'value': '592', 'groupId': 'OG000'}, {'value': '586', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to day 90', 'description': 'Disease severity measured by invasive mechanical ventilation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Who Died', 'denoms': [{'units': 'Participants', 'counts': [{'value': '592', 'groupId': 'OG000'}, {'value': '589', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SARS-CoV-2 Convalescent Plasma', 'description': 'SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.\n\nSARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.'}, {'id': 'OG001', 'title': 'Standard Control Plasma', 'description': 'Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.\n\nPlasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.'}], 'classes': [{'categories': [{'title': 'Deaths', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'No deaths', 'measurements': [{'value': '592', 'groupId': 'OG000'}, {'value': '586', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to day 90', 'description': 'Disease severity measured by death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes patients who were randomized and received transfusion'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Resolved COVID-19 Symptoms at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '560', 'groupId': 'OG000'}, {'value': '554', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SARS-CoV-2 Convalescent Plasma', 'description': 'SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.\n\nSARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.'}, {'id': 'OG001', 'title': 'Standard Control Plasma', 'description': 'Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.\n\nPlasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.'}], 'classes': [{'categories': [{'measurements': [{'value': '146', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.65', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 14', 'description': 'Number of participants with resolved COVID-19 symptoms at day 14', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were transfused and had symptom data for day 14'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Resolved COVID-19 Symptoms at Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '553', 'groupId': 'OG000'}, {'value': '544', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SARS-CoV-2 Convalescent Plasma', 'description': 'SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.\n\nSARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.'}, {'id': 'OG001', 'title': 'Standard Control Plasma', 'description': 'Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.\n\nPlasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.'}], 'classes': [{'categories': [{'measurements': [{'value': '250', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 28', 'description': 'Number of participants with resolved COVID-19 symptoms at day 28', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were transfused and had symptom data for day 28'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Resolved COVID-19 Symptoms at Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '533', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SARS-CoV-2 Convalescent Plasma', 'description': 'SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.\n\nSARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.'}, {'id': 'OG001', 'title': 'Standard Control Plasma', 'description': 'Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.\n\nPlasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.'}], 'classes': [{'categories': [{'measurements': [{'value': '359', 'groupId': 'OG000'}, {'value': '347', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 90', 'description': 'Number of participants with resolved COVID-19 symptoms at day 90', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were transfused and had symptom data for day 90'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Impact of Convalescent Plasma on Outcome as Assessed by Change in Hospitalization Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '592', 'groupId': 'OG000'}, {'value': '589', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SARS-CoV-2 Convalescent Plasma Total Age < 65', 'description': 'SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.\n\nSARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.'}, {'id': 'OG001', 'title': 'Standard Control Plasma Total Age <65', 'description': 'Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.\n\nPlasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.'}], 'classes': [{'title': 'Age group < 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '552', 'groupId': 'OG000'}, {'value': '549', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Primary event of hospitalization', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}, {'title': 'No primary event of hospitalization', 'measurements': [{'value': '540', 'groupId': 'OG000'}, {'value': '520', 'groupId': 'OG001'}]}]}, {'title': 'Age group >= 65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Primary event of hospitalization', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'No primary event of hospitalization', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0 to Day 90', 'description': 'Assess change in hospitalization rate as measured by number of hospitalizations stratified by age groups \\<65 and \\>=65', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes patients who were randomized and received transfusion'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Impact of Donor Antibody Titers on Hospitalization Rate of Convalescent Plasma Recipients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SARS-CoV-2 Convalescent Plasma (High Titer)', 'description': 'High titer refers \\>= median donor dilutional neutralizing virus titer'}, {'id': 'OG001', 'title': 'SARS-CoV-2 Convalescent Plasma (Low Titer)', 'description': 'Low titer refers to \\< median donor dilutional neutralizing virus titer'}], 'classes': [{'categories': [{'title': 'Hospitalized', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Not hospitalized', 'measurements': [{'value': '296', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.525', 'ciLowerLimit': '0.192', 'ciUpperLimit': '1.425', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 0 to Day28', 'description': 'Impact of donor antibody titers (high/low) will be assessed by hospitalization rate as measured by number of hospitalizations.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis limited to those that had the donor titer measured'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SARS-CoV-2 Convalescent Plasma', 'description': 'SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.\n\nSARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.'}, {'id': 'FG001', 'title': 'Standard Control Plasma', 'description': 'Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.\n\nPlasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '610'}, {'groupId': 'FG001', 'numSubjects': '615'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '592'}, {'groupId': 'FG001', 'numSubjects': '589'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Did not receive tranfusion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '26'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '592', 'groupId': 'BG000'}, {'value': '589', 'groupId': 'BG001'}, {'value': '1181', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SARS-CoV-2 Convalescent Plasma', 'description': 'SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.\n\nSARS-CoV-2 convalescent plasma: SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.'}, {'id': 'BG001', 'title': 'Standard Control Plasma', 'description': 'Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.\n\nPlasma from a volunteer donor: Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000', 'lowerLimit': '32', 'upperLimit': '54'}, {'value': '44', 'groupId': 'BG001', 'lowerLimit': '33', 'upperLimit': '55'}, {'value': '43', 'groupId': 'BG002', 'lowerLimit': '32', 'upperLimit': '54'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': '18 - 34 years', 'measurements': [{'value': '190', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '355', 'groupId': 'BG002'}]}, {'title': '35 - 49 years', 'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '208', 'groupId': 'BG001'}, {'value': '415', 'groupId': 'BG002'}]}, {'title': '50 - 64 years', 'measurements': [{'value': '155', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '331', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '323', 'groupId': 'BG000'}, {'value': '352', 'groupId': 'BG001'}, {'value': '675', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '269', 'groupId': 'BG000'}, {'value': '237', 'groupId': 'BG001'}, {'value': '506', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '512', 'groupId': 'BG000'}, {'value': '499', 'groupId': 'BG001'}, {'value': '1011', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '459', 'groupId': 'BG000'}, {'value': '475', 'groupId': 'BG001'}, {'value': '934', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI category 1', 'classes': [{'categories': [{'title': '<30', 'measurements': [{'value': '382', 'groupId': 'BG000'}, {'value': '355', 'groupId': 'BG001'}, {'value': '737', 'groupId': 'BG002'}]}, {'title': '>=30', 'measurements': [{'value': '210', 'groupId': 'BG000'}, {'value': '234', 'groupId': 'BG001'}, {'value': '444', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI category 2', 'classes': [{'categories': [{'title': '<35', 'measurements': [{'value': '495', 'groupId': 'BG000'}, {'value': '482', 'groupId': 'BG001'}, {'value': '977', 'groupId': 'BG002'}]}, {'title': '>=35', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertension', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '276', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '452', 'groupId': 'BG000'}, {'value': '453', 'groupId': 'BG001'}, {'value': '905', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '543', 'groupId': 'BG000'}, {'value': '539', 'groupId': 'BG001'}, {'value': '1082', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Asthma', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '533', 'groupId': 'BG000'}, {'value': '516', 'groupId': 'BG001'}, {'value': '1049', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HIV infection', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '579', 'groupId': 'BG000'}, {'value': '577', 'groupId': 'BG001'}, {'value': '1156', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pregnant', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '590', 'groupId': 'BG000'}, {'value': '588', 'groupId': 'BG001'}, {'value': '1178', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Time from symptom onset to transfusion', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000', 'lowerLimit': '4', 'upperLimit': '7'}, {'value': '6', 'groupId': 'BG001', 'lowerLimit': '4', 'upperLimit': '7'}, {'value': '6', 'groupId': 'BG002', 'lowerLimit': '4', 'upperLimit': '7'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'days', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Vaccine status', 'classes': [{'categories': [{'title': 'Unvaccinated', 'measurements': [{'value': '486', 'groupId': 'BG000'}, {'value': '479', 'groupId': 'BG001'}, {'value': '965', 'groupId': 'BG002'}]}, {'title': 'Partially vaccinated', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'Fully vaccinated', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Includes participants who were randomized and received transfusion'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-04', 'size': 1500161, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-12-08T09:30', 'hasProtocol': True}, {'date': '2021-11-02', 'size': 1133656, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-12-08T09:41', 'hasProtocol': False}, {'date': '2021-07-21', 'size': 775618, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-12-08T09:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A total of approximately 1344 eligible subjects stratified with a target goal (but not binding) of 50:50 in the \\<65 vs ≥ 65 age range will be randomized in a 1:1 ratio to receive either HCIP or control plasma.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1225}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-03', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-31', 'studyFirstSubmitDate': '2020-04-30', 'resultsFirstSubmitDate': '2022-12-21', 'studyFirstSubmitQcDate': '2020-04-30', 'lastUpdatePostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-18', 'studyFirstPostDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With ICU Admission', 'timeFrame': 'Up to day 90', 'description': 'Disease severity measured by admission to the ICU'}, {'measure': 'Number of Participants With Invasive Mechanical Ventilation', 'timeFrame': 'Up to day 90', 'description': 'Disease severity measured by invasive mechanical ventilation'}, {'measure': 'Number of Participants Who Died', 'timeFrame': 'Up to day 90', 'description': 'Disease severity measured by death'}, {'measure': 'Number of Participants With Resolved COVID-19 Symptoms at Day 14', 'timeFrame': 'Day 14', 'description': 'Number of participants with resolved COVID-19 symptoms at day 14'}, {'measure': 'Number of Participants With Resolved COVID-19 Symptoms at Day 28', 'timeFrame': 'Day 28', 'description': 'Number of participants with resolved COVID-19 symptoms at day 28'}, {'measure': 'Number of Participants With Resolved COVID-19 Symptoms at Day 90', 'timeFrame': 'Day 90', 'description': 'Number of participants with resolved COVID-19 symptoms at day 90'}, {'measure': 'Impact of Convalescent Plasma on Outcome as Assessed by Change in Hospitalization Rate', 'timeFrame': 'Day 0 to Day 90', 'description': 'Assess change in hospitalization rate as measured by number of hospitalizations stratified by age groups \\<65 and \\>=65'}, {'measure': 'Impact of Donor Antibody Titers on Hospitalization Rate of Convalescent Plasma Recipients', 'timeFrame': 'Day 0 to Day28', 'description': 'Impact of donor antibody titers (high/low) will be assessed by hospitalization rate as measured by number of hospitalizations.'}], 'primaryOutcomes': [{'measure': 'Cumulative Number of Hospitalizations or Deaths Prior to Hospitalization', 'timeFrame': 'Up to day 28', 'description': 'Cumulative Number measured as the proportion of subjects who were hospitalized or who died prior to hospitalization'}, {'measure': 'Cumulative Incidence of Severe Infusion Reactions', 'timeFrame': 'Up to day 28', 'description': 'Cumulative incidence measured as rate per person-years experiencing treatment-related severe infusion reactions during the study period.'}, {'measure': 'Cumulative Incidence of Treatment-related Grade 3 or Higher Adverse Events', 'timeFrame': 'Up to day 90', 'description': 'Cumulative incidence measured as rate per person-years experiencing a Grade 3 or higher.'}, {'measure': 'Cumulative Incidence of Treatment-related Acute Respiratory Distress Syndrome (ARDS)', 'timeFrame': 'Up to day 28', 'description': 'Cumulative incidence measured as rate per person-years of treatment-related severe Acute Respiratory Distress Syndrome (ARDS) during the study period.'}], 'secondaryOutcomes': [{'measure': 'Serum SARS-CoV-2 Antibody Titers by Visit', 'timeFrame': 'Days 0, 14, 28 and 90', 'description': 'Geometric mean Spike Receptor Binding Domain (RBD) titers at day 0, 14, 28 and 90 between the randomized arms.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19'], 'conditions': ['SARS-CoV 2']}, 'referencesModule': {'references': [{'pmid': '34981068', 'type': 'RESULT', 'citation': 'Sullivan DJ, Gebo KA, Shoham S, Bloch EM, Lau B, Shenoy AG, Mosnaim GS, Gniadek TJ, Fukuta Y, Patel B, Heath SL, Levine AC, Meisenberg BR, Spivak ES, Anjan S, Huaman MA, Blair JE, Currier JS, Paxton JH, Gerber JM, Petrini JR, Broderick PB, Rausch W, Cordisco ME, Hammel J, Greenblatt B, Cluzet VC, Cruser D, Oei K, Abinante M, Hammitt LL, Sutcliffe CG, Forthal DN, Zand MS, Cachay ER, Raval JS, Kassaye SG, Foster EC, Roth M, Marshall CE, Yarava A, Lane K, McBee NA, Gawad AL, Karlen N, Singh A, Ford DE, Jabs DA, Appel LJ, Shade DM, Ehrhardt S, Baksh SN, Laeyendecker O, Pekosz A, Klein SL, Casadevall A, Tobian AAR, Hanley DF. Randomized Controlled Trial of Early Outpatient COVID-19 Treatment with High-Titer Convalescent Plasma. medRxiv [Preprint]. 2021 Dec 21:2021.12.10.21267485. doi: 10.1101/2021.12.10.21267485.'}, {'pmid': '38483534', 'type': 'DERIVED', 'citation': 'Park HS, Yin A, Barranta C, Lee JS, Caputo CA, Sachithanandham J, Li M, Yoon S, Sitaras I, Jedlicka A, Eby Y, Ram M, Fernandez RE, Baker OR, Shenoy AG, Mosnaim GS, Fukuta Y, Patel B, Heath SL, Levine AC, Meisenberg BR, Spivak ES, Anjan S, Huaman MA, Blair JE, Currier JS, Paxton JH, Gerber JM, Petrini JR, Broderick PB, Rausch W, Cordisco ME, Hammel J, Greenblatt B, Cluzet VC, Cruser D, Oei K, Abinante M, Hammitt LL, Sutcliffe CG, Forthal DN, Zand MS, Cachay ER, Raval JS, Kassaye SG, Marshall CE, Yarava A, Lane K, McBee NA, Gawad AL, Karlen N, Singh A, Ford DE, Jabs DA, Appel LJ, Shade DM, Lau B, Ehrhardt S, Baksh SN, Shapiro JR, Ou J, Na YB, Knoll MD, Ornelas-Gatdula E, Arroyo-Curras N, Gniadek TJ, Caturegli P, Wu J, Ndahiro N, Betenbaugh MJ, Ziman A, Hanley DF, Casadevall A, Shoham S, Bloch EM, Gebo KA, Tobian AA, Laeyendecker O, Pekosz A, Klein SL, Sullivan DJ. Outpatient COVID-19 convalescent plasma recipient antibody thresholds correlated to reduced hospitalizations within a randomized trial. JCI Insight. 2024 Mar 14;9(8):e178460. doi: 10.1172/jci.insight.178460.'}, {'pmid': '37131659', 'type': 'DERIVED', 'citation': 'Park HS, Yin A, Barranta C, Lee JS, Caputo CA, Sachithanandham J, Li M, Yoon S, Sitaras I, Jedlicka A, Eby Y, Ram M, Fernandez RE, Baker OR, Shenoy AG, Mosnaim GS, Fukuta Y, Patel B, Heath SL, Levine AC, Meisenberg BR, Spivak ES, Anjan S, Huaman MA, Blair JE, Currier JS, Paxton JH, Gerber JM, Petrini JR, Broderick PB, Rausch W, Cordisco ME, Hammel J, Greenblatt B, Cluzet VC, Cruser D, Oei K, Abinante M, Hammitt LL, Sutcliffe CG, Forthal DN, Zand MS, Cachay ER, Raval JS, Kassaye SG, Marshall CE, Yarava A, Lane K, McBee NA, Gawad AL, Karlen N, Singh A, Ford DE, Jabs DA, Appel LJ, Shade DM, Lau B, Ehrhardt S, Baksh SN, Shapiro JR, Ou J, Na YB, Knoll MD, Ornelas-Gatdula E, Arroyo-Curras N, Gniadek TJ, Caturegli P, Wu J, Ndahiro N, Betenbaugh MJ, Ziman A, Hanley DF, Casadevall A, Shoham S, Bloch EM, Gebo KA, Tobian AAR, Laeyendecker O, Pekosz A, Klein SL, Sullivan DJ. Outpatient COVID-19 convalescent plasma recipient antibody thresholds correlated to reduced hospitalizations within a randomized trial. medRxiv [Preprint]. 2023 Dec 15:2023.04.13.23288353. doi: 10.1101/2023.04.13.23288353.'}, {'pmid': '36722044', 'type': 'DERIVED', 'citation': 'Baksh SN, Heath SL, Fukuta Y, Shade D, Meisenberg B, Bloch EM, Tobian AAR, Spivak ES, Patel B, Gerber J, Raval JS, Forthal D, Paxton J, Mosnaim G, Anjan S, Blair J, Cachay E, Currier J, Das P, Huaman M, Sutcliffe C, Yarava A, Casadevall A, Sullivan D, Hanley D, Gebo KA. Symptom Duration and Resolution With Early Outpatient Treatment of Convalescent Plasma for Coronavirus Disease 2019: A Randomized Trial. J Infect Dis. 2023 May 29;227(11):1266-1273. doi: 10.1093/infdis/jiad023.'}, {'pmid': '35353960', 'type': 'DERIVED', 'citation': 'Sullivan DJ, Gebo KA, Shoham S, Bloch EM, Lau B, Shenoy AG, Mosnaim GS, Gniadek TJ, Fukuta Y, Patel B, Heath SL, Levine AC, Meisenberg BR, Spivak ES, Anjan S, Huaman MA, Blair JE, Currier JS, Paxton JH, Gerber JM, Petrini JR, Broderick PB, Rausch W, Cordisco ME, Hammel J, Greenblatt B, Cluzet VC, Cruser D, Oei K, Abinante M, Hammitt LL, Sutcliffe CG, Forthal DN, Zand MS, Cachay ER, Raval JS, Kassaye SG, Foster EC, Roth M, Marshall CE, Yarava A, Lane K, McBee NA, Gawad AL, Karlen N, Singh A, Ford DE, Jabs DA, Appel LJ, Shade DM, Ehrhardt S, Baksh SN, Laeyendecker O, Pekosz A, Klein SL, Casadevall A, Tobian AAR, Hanley DF. Early Outpatient Treatment for Covid-19 with Convalescent Plasma. N Engl J Med. 2022 May 5;386(18):1700-1711. doi: 10.1056/NEJMoa2119657. Epub 2022 Mar 30.'}]}, 'descriptionModule': {'briefSummary': 'To assess the efficacy and safety of Human coronavirus immune plasma (HCIP) to reduce the risk of hospitalization or death, the duration of symptoms and duration of nasopharyngeal or oropharyngeal viral shedding.', 'detailedDescription': 'The purpose of this randomized, double-blind, controlled, phase 2 trial is to evaluate the efficacy of treatment with HCIP in reducing hospitalization and death prior to hospitalization among outpatient adults who have RNA detection test-confirmed COVID-19 AND have developed any symptoms of COVID-19 including but not limited to fever, cough, or other COVID associated symptoms like anosmia. Ambulatory/outpatient adults subjects 18 years of age or older, regardless of risk factors for severe illness may participate. A total of approximately 1344 eligible subjects stratified with a target goal (but not binding) of 50:50 in the \\<65 vs ≥ 65 age range will be randomized in a 1:1 ratio to receive either HCIP or control plasma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years of age\n* Competent and capable to provide informed consent\n* • Positive molecular test for presence of SARS-CoV-2 in fluid collected by saliva for antigen, oropharyngeal or nasopharyngeal swab\n* Experiencing any symptoms of COVID-19 including but not limited to fever(T\\> 100.5º F), cough, or other COVID associated symptoms like anosmia\n* ≤ 8 days since the first symptoms of COVID-19\n* ≤ 8 days since first positive SARS-CoV-2 RNA test\n* Able and willing to comply with protocol requirements listed in the informed consent\n\nExclusion Criteria:\n\n* Hospitalized or expected to be hospitalized within 24 hours of enrollment\n* Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance\n* History of prior reactions to transfusion blood products\n* Inability to complete therapy with the study product within 24 hours after enrollment\n* Receiving any treatment drug for COVID-19 within 14 days prior to screening evaluation (monoclonal antibodies, compassionate use or study trial related). Steroid treatment at any time does not affect study eligibility'}, 'identificationModule': {'nctId': 'NCT04373460', 'acronym': 'CSSC-004', 'briefTitle': 'Convalescent Plasma to Limit SARS-CoV-2 Associated Complications', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Comparison of the Efficacy and Safety of Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune) Plasma Among Outpatients With Symptomatic COVID-19', 'orgStudyIdInfo': {'id': 'IRB00247590'}, 'secondaryIdInfos': [{'id': 'R01AI152078', 'link': 'https://reporter.nih.gov/quickSearch/R01AI152078', 'type': 'NIH'}, {'id': 'W911QY2090012', 'type': 'OTHER_GRANT', 'domain': 'Department of Defense'}, {'id': 'U24TR001609', 'link': 'https://reporter.nih.gov/quickSearch/U24TR001609', 'type': 'NIH'}, {'id': 'UL1TR003098', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR003098', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SARS-CoV-2 convalescent plasma', 'description': 'SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.', 'interventionNames': ['Biological: SARS-CoV-2 convalescent plasma']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Control plasma', 'description': 'Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.', 'interventionNames': ['Biological: Plasma from a volunteer donor']}], 'interventions': [{'name': 'SARS-CoV-2 convalescent plasma', 'type': 'BIOLOGICAL', 'otherNames': ['Human coronavirus immune plasma (HCIP)'], 'description': 'SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.', 'armGroupLabels': ['SARS-CoV-2 convalescent plasma']}, {'name': 'Plasma from a volunteer donor', 'type': 'BIOLOGICAL', 'description': 'Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.', 'armGroupLabels': ['Standard Control plasma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '86503', 'city': 'Chinle', 'state': 'Arizona', 'country': 'United States', 'facility': 'Center for American Indian Health - Chinle Office', 'geoPoint': {'lat': 36.15445, 'lon': -109.55261}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic, Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona, Phoenix', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona, Tuscon', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85941', 'city': 'Whiteriver', 'state': 'Arizona', 'country': 'United States', 'facility': 'Center for American Indian Health - Whiteriver Office', 'geoPoint': {'lat': 33.83699, 'lon': -109.96427}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Irvine Health', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '06810', 'city': 'Danbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Western Connecticut Health Network, Danbury Hospital', 'geoPoint': {'lat': 41.39482, 'lon': -73.45401}}, {'zip': '06856', 'city': 'Norwalk', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Western Connecticut Health Network, Norwalk Hospital', 'geoPoint': {'lat': 41.1176, 'lon': -73.4079}}, {'zip': '33124', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Clinical Translational Research Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'NorthShore University HealthSystem', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane University', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21401', 'city': 'Annapolis', 'state': 'Maryland', 'country': 'United States', 'facility': 'Anne Arundel Medical Center', 'geoPoint': {'lat': 38.97859, 'lon': -76.49184}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20782', 'city': 'Hyattsville', 'state': 'Maryland', 'country': 'United States', 'facility': 'MedStar Washington Hospital Center', 'geoPoint': {'lat': 38.95594, 'lon': -76.94553}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Worcester', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Health Sciences Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '87301', 'city': 'Gallup', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Center for American Indian Health - Gallup Office', 'geoPoint': {'lat': 35.52808, 'lon': -108.74258}}, {'zip': '87420', 'city': 'Shiprock', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Center for American Indian Health - Shiprock Office', 'geoPoint': {'lat': 36.78555, 'lon': -108.68703}}, {'zip': '12601', 'city': 'Poughkeepsie', 'state': 'New York', 'country': 'United States', 'facility': 'Vassar Brothers Medical Center', 'geoPoint': {'lat': 41.70037, 'lon': -73.92097}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati Medical Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Lifespan/BrownUniversity (Rhode Island Hospital)', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'The University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'David J Sullivan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'After publication of initial study manuscript', 'ipdSharing': 'YES', 'description': 'Anonymized individual participant data (IPD) collected in this study, including data dictionaries, will be made available to other researchers after the end of the study.', 'accessCriteria': 'Public'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'State of Maryland', 'class': 'OTHER_GOV'}, {'name': 'Bloomberg Philanthropies', 'class': 'OTHER'}, {'name': 'United States Department of Defense', 'class': 'FED'}, {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, {'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}