Viewing Study NCT03570918

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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-25 @ 4:53 AM

Ignite Modification Date: 2025-12-26 @ 3:54 AM

Study NCT ID: NCT03570918

Status: COMPLETED

Last Update Posted: 2022-09-02

First Post: 2018-06-18

Is NOT Gene Therapy: False

Has Adverse Events: True

Brief Title: MGD014 in HIV-Infected Individuals on Suppressive Antiretroviral Therapy

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@Macrogenics.com', 'phone': '301-251-5172', 'title': 'Chief Medical Officer', 'organization': 'MacroGenics, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'up to 19 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'MGD014 0.1 mcg/kg', 'description': 'Single infusion of MGD014', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MGD014 0.3 mcg/kg', 'description': 'Single infusion of MGD014', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'MGD014 1.0 mcg/kg', 'description': 'Single infusion of MGD014', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'MGD014 3.0 mcg/kg', 'description': 'Single infusion of MGD014', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'MGD014 10.0 mcg/kg', 'description': 'Single infusion of MGD014', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'MGD014 30 mcg/kg', 'description': 'Single infusion of MGD014', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'MGD014 100 mcg/kg', 'description': 'Single infusion of MGD014', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'MGD014 300 mcg/kg', 'description': 'Single infusion of MGD014', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Multiple Dose MGD014 300 mcg/kg', 'description': 'Infusion every 2 weeks for 3 infusions.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lymph node pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Lymphadenopathy', 'notes': 'swollen lymph nodes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Cerumen impaction', 'notes': 'earwax impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Application site erythema', 'notes': 'Application site redness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vessel puncture site bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vessel puncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Infusion site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vessel puncture site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Arthropod bite', 'notes': 'Insect bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Eye contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Electrocardiogram abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, 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{'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 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'title': 'MGD014 10.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG005', 'title': 'MGD014 30.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG006', 'title': 'MGD014 100.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG007', 'title': 'MGD014 300.0 mcg/kg', 'description': 'a single or multiple IV infusions of MGD014'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'comment': 'Not calculable for 1 participant', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5.8', 'comment': 'Not calculable for 1 participant', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '24.5', 'groupId': 'OG002', 'lowerLimit': '13.7', 'upperLimit': '35.3'}, {'value': '67.7', 'groupId': 'OG003', 'lowerLimit': '50.3', 'upperLimit': '85.1'}, {'value': '181', 'groupId': 'OG004', 'lowerLimit': '161', 'upperLimit': '200'}, {'value': '469', 'groupId': 'OG005', 'lowerLimit': '390', 'upperLimit': '548'}, {'value': '1640', 'groupId': 'OG006', 'lowerLimit': '1130', 'upperLimit': '2160'}, {'value': '5288.4', 'groupId': 'OG007', 'lowerLimit': '4590', 'upperLimit': '5870'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study Day 0', 'description': 'Cmax is the maximum (or peak) serum concentration of a drug in the body after the drug has been administered', 'unitOfMeasure': 'mcg/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tmax: Time to Maximum Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'MGD014 0.1 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG001', 'title': 'MGD014 0.3 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG002', 'title': 'MGD014 1.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG003', 'title': 'MGD014 3.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG004', 'title': 'MGD014 10.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG005', 'title': 'MGD014 30.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG006', 'title': 'MGD014 100.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG007', 'title': 'MGD014 300.0 mcg/kg', 'description': 'a single or multiple IV infusions of MGD014'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'comment': 'not calculable for one participant', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.9', 'comment': 'not calculable for one participant', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '2.4', 'groupId': 'OG002', 'lowerLimit': '1.6', 'upperLimit': '3.1'}, {'value': '2.0', 'groupId': 'OG003', 'lowerLimit': '1.9', 'upperLimit': '2.0'}, {'value': '2.7', 'groupId': 'OG004', 'lowerLimit': '1.9', 'upperLimit': '3.4'}, {'value': '1.9', 'groupId': 'OG005', 'lowerLimit': '1.9', 'upperLimit': '2.0'}, {'value': '2.6', 'groupId': 'OG006', 'lowerLimit': '1.9', 'upperLimit': '3.4'}, {'value': '2.5', 'groupId': 'OG007', 'lowerLimit': '2.0', 'upperLimit': '2.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study Day 0', 'description': 'Tmax is the time it takes a drug to reach the maximum concentration', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ctrough: Trough Level Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'MGD014 0.1 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG001', 'title': 'MGD014 0.3 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG002', 'title': 'MGD014 1.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG003', 'title': 'MGD014 3.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG004', 'title': 'MGD014 10.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG005', 'title': 'MGD014 30.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG006', 'title': 'MGD014 100.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG007', 'title': 'MGD014 300.0 mcg/kg', 'description': 'multiple IV infusions of MGD014'}], 'classes': [{'categories': [{'measurements': [{'value': '320', 'groupId': 'OG007', 'lowerLimit': '252', 'upperLimit': '338'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study Day 14', 'description': 'a trough level or trough concentration (Ctrough) is the concentration reached by a drug immediately before the next dose is administered,', 'unitOfMeasure': 'mcg/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Mean trough concentration for the 300 mcg/kg dose is from the first MGD014 infusion (taken at Day 14) for participants (n=3) in Part 2 only. Trough concentration is not applicable for single-dose cohorts.'}, {'type': 'SECONDARY', 'title': 'Clearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'MGD014 0.1 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG001', 'title': 'MGD014 0.3 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG002', 'title': 'MGD014 1.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG003', 'title': 'MGD014 3.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG004', 'title': 'MGD014 10.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG005', 'title': 'MGD014 30.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG006', 'title': 'MGD014 100.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG007', 'title': 'MGD014 300.0 mcg/kg', 'description': 'a single or multiple IV infusions of MGD014'}], 'classes': [{'categories': [{'measurements': [{'value': '0.04', 'comment': 'not calculable for one participant', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.07', 'comment': 'not calculable for one participant', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.03', 'groupId': 'OG002', 'lowerLimit': '0.02', 'upperLimit': '0.04'}, {'value': '0.05', 'groupId': 'OG003', 'lowerLimit': '0.04', 'upperLimit': '0.05'}, {'value': '0.04', 'groupId': 'OG004', 'lowerLimit': '0.04', 'upperLimit': '0.05'}, {'value': '0.04', 'groupId': 'OG005', 'lowerLimit': '0.04', 'upperLimit': '0.05'}, {'value': '0.05', 'groupId': 'OG006', 'lowerLimit': '0.04', 'upperLimit': '0.06'}, {'value': '0.05', 'groupId': 'OG007', 'lowerLimit': '0.05', 'upperLimit': '0.06'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study Day 0 to 42', 'description': 'Total body clearance of the drug from plasma of MGD014', 'unitOfMeasure': 'L/hr', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vz: Terminal Phase Volume of Distribution of MGD014', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'MGD014 0.1 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG001', 'title': 'MGD014 0.3 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG002', 'title': 'MGD014 1.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG003', 'title': 'MGD014 3.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG004', 'title': 'MGD014 10.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG005', 'title': 'MGD014 30.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG006', 'title': 'MGD014 100.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG007', 'title': 'MGD014 300.0 mcg/kg', 'description': 'a single or multiple IV infusions of MGD014'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'comment': 'not calculable for one participant', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.1', 'comment': 'not calculable for one participant.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '8.7', 'groupId': 'OG002', 'lowerLimit': '6.2', 'upperLimit': '11.2'}, {'value': '19.7', 'groupId': 'OG003', 'lowerLimit': '14.2', 'upperLimit': '25.2'}, {'value': '17.5', 'groupId': 'OG004', 'lowerLimit': '16.9', 'upperLimit': '18.2'}, {'value': '17.4', 'groupId': 'OG005', 'lowerLimit': '15.4', 'upperLimit': '19.3'}, {'value': '21.6', 'groupId': 'OG006', 'lowerLimit': '16.9', 'upperLimit': '26.2'}, {'value': '15.8', 'groupId': 'OG007', 'lowerLimit': '9.1', 'upperLimit': '22.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study Day 1, 2, 7, 14, 21, 28, and 42 (single infusion) and Study Day 1, 3, 14, 28, 42, and 77 (multiple infusions)', 'description': 'The ratio of the total quantity of drug in the body to drug plasma concentration during the elimination', 'unitOfMeasure': 'liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Terminal Half Life of MGD014', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'MGD014 0.1 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG001', 'title': 'MGD014 0.3 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG002', 'title': 'MGD014 1.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG003', 'title': 'MGD014 3.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG004', 'title': 'MGD014 10.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG005', 'title': 'MGD014 30.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG006', 'title': 'MGD014 100.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG007', 'title': 'MGD014 300.0 mcg/kg', 'description': 'a single or multiple IV infusions of MGD014'}], 'classes': [{'categories': [{'measurements': [{'value': '32.0', 'comment': 'not calculable for one participant', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '38.6', 'comment': 'not calculable for one participant', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '244', 'groupId': 'OG002', 'lowerLimit': '136', 'upperLimit': '351'}, {'value': '300', 'groupId': 'OG003', 'lowerLimit': '227', 'upperLimit': '373'}, {'value': '295', 'groupId': 'OG004', 'lowerLimit': '266', 'upperLimit': '323'}, {'value': '282', 'groupId': 'OG005', 'lowerLimit': '276', 'upperLimit': '288'}, {'value': '285', 'groupId': 'OG006', 'lowerLimit': '269', 'upperLimit': '300'}, {'value': '295', 'groupId': 'OG007', 'lowerLimit': '289', 'upperLimit': '305'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Study Day 0 to Study Day 42', 'description': 'The half-life is the amount of time required for 50% of the drug to be removed from the body', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Average terminal half-life did not include participants in Part 2 (n=3) due to a shortened PK schedule that did not support estimation of half-life'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Developed Antidrug Antibodies to MGD014', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'MGD014 0.1 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG001', 'title': 'MGD014 0.3 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG002', 'title': 'MGD014 1.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG003', 'title': 'MGD014 3.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG004', 'title': 'MGD014 10.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG005', 'title': 'MGD014 30.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG006', 'title': 'MGD014 100.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG007', 'title': 'MGD014 300.0 mcg/kg', 'description': 'a single or multiple IV infusions of MGD014'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Study Day 1, 14, 28 and 42 (single infusion) and Study Day 1, 14, 28 and 77 (multiple infusions)', 'description': 'Number of participants with antidrug antibodies to MGD014', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Increased Cytokine Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'MGD014 0.1 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG001', 'title': 'MGD014 0.3 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG002', 'title': 'MGD014 1.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG003', 'title': 'MGD014 3.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG004', 'title': 'MGD014 10.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG005', 'title': 'MGD014 30.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG006', 'title': 'MGD014 100.0 mcg/kg', 'description': 'a single IV infusion of MGD014'}, {'id': 'OG007', 'title': 'MGD014 300.0 mcg/kg', 'description': 'a single or multiple IV infusions of MGD014'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Study Day 1, 2 and 7 (single infusion) and Study Day 1, 3, 14 and 28 (multiple infusions)', 'description': 'Number of participants with increased cytokine levels from baseline after MGD014 administration. This safety measure compares serum cytokine levels obtained prior to dosing with levels obtained after dosing. Increased cytokines can be a measure of T-cell activation in response to MGD014 binding. Cytokines analyzed included interferon-gamma, tumor necrosis factor-alpha, interleukin (IL)2, IL-5, IL-6, and IL-10.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MGD014 0.1 Micrograms/Kilogram (mcg/kg)', 'description': 'a single 2-hour infusion\n\nMGD014: HIV-1 x CD3 bispecific DART molecule'}, {'id': 'FG001', 'title': 'MGD014 0.3 mcg/kg', 'description': 'a single 2-hour infusion\n\nMGD014: HIV-1 x CD3 bispecific DART molecule'}, {'id': 'FG002', 'title': 'MGD014 1.0 mcg/kg', 'description': 'a single 2-hour infusion\n\nMGD014: HIV-1 x CD3 bispecific DART molecule'}, {'id': 'FG003', 'title': 'MGD014 3.0 mcg/kg', 'description': 'a single 2-hour infusion\n\nMGD014: HIV-1 x CD3 bispecific DART molecule'}, {'id': 'FG004', 'title': 'MGD014 10.0 mcg/kg', 'description': 'a single 2-hour infusion\n\nMGD014: HIV-1 x CD3 bispecific DART molecule'}, {'id': 'FG005', 'title': 'MGD014 30.0 mcg/kg', 'description': 'a single 2-hour infusion\n\nMGD014: HIV-1 x CD3 bispecific DART molecule'}, {'id': 'FG006', 'title': 'MGD014 100.0 mcg/kg', 'description': 'a single 2-hour infusion\n\nMGD014: HIV-1 x CD3 bispecific DART molecule'}, {'id': 'FG007', 'title': 'MGD014 300.0 mcg/kg', 'description': 'a single 2-hour infusion\n\nMGD014: HIV-1 x CD3 bispecific DART molecule'}, {'id': 'FG008', 'title': 'MGD014 300 mcg/kg Multiple Doses', 'description': '3 infusions given every 2 weeks over 4 weeks.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Three participants who were treated in Period 1 (single dose) in the 10, 100, or 300 mcg/kg dose cohorts were also treated in Period 2 (multiple dose) in the 300 mcg/kg dose cohort.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '21', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'MGD014 0.1 mcg/kg', 'description': 'Single infusion of MGD014'}, {'id': 'BG001', 'title': 'MGD014 0.3 mcg/kg', 'description': 'Single infusion of MGD014'}, {'id': 'BG002', 'title': 'MGD014 1.0 mcg/kg', 'description': 'Single infusion of MGD014'}, {'id': 'BG003', 'title': 'MGD014 3.0 mcg/kg', 'description': 'Single infusion of MGD014'}, {'id': 'BG004', 'title': 'MGD014 10.0 mcg/kg', 'description': 'Single infusion of MGD014'}, {'id': 'BG005', 'title': 'MGD014 30 mcg/kg', 'description': 'Single infusion of MGD014'}, {'id': 'BG006', 'title': 'MGD014 100 mcg/kg', 'description': 'Single infusion of MGD014'}, {'id': 'BG007', 'title': 'MGD014 300 mcg/kg', 'description': 'Single infusion of MGD014'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Period 1: Single Dose', 'categories': [{'measurements': [{'value': '40.0', 'spread': 'NA', 'comment': 'not applicable for a single participant', 'groupId': 'BG000'}, {'value': '53.0', 'spread': 'NA', 'comment': 'not applicable for a single participant', 'groupId': 'BG001'}, {'value': '49.8', 'spread': '9.18', 'groupId': 'BG002'}, {'value': '37.9', 'spread': '5.51', 'groupId': 'BG003'}, {'value': '56.7', 'spread': '7.09', 'groupId': 'BG004'}, {'value': '41.0', 'spread': '10.82', 'groupId': 'BG005'}, {'value': '33.7', 'spread': '5.86', 'groupId': 'BG006'}, {'value': '42.3', 'spread': '17.10', 'groupId': 'BG007'}, {'value': '44.4', 'spread': '11.00', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'The 3 participants treated with multiple doses of MGD014 were also treated with single doses of MGD014 at 10, 100 and 300 mg, respectively'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Single dose', 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '21', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '19', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '13', 'groupId': 'BG008'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'The 3 participants treated with multiple doses of MGD014 were also treated with single doses of MGD014 at 10, 100 and 300 mg, respectively.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-31', 'size': 6426027, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-02-07T17:25', 'hasProtocol': True}, {'date': '2021-03-17', 'size': 3551450, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-02-07T17:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Open-label dose-escalation study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-31', 'studyFirstSubmitDate': '2018-06-18', 'resultsFirstSubmitDate': '2022-02-07', 'studyFirstSubmitQcDate': '2018-06-18', 'lastUpdatePostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-31', 'studyFirstPostDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emerging Adverse Events', 'timeFrame': 'up to 77 days', 'description': 'Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit.'}], 'secondaryOutcomes': [{'measure': 'AUC Inf: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity of MGD014', 'timeFrame': 'Study Day 0 to 42', 'description': 'AUCinf, area under the concentration-time curve from the time of dose extrapolated to time infinity and reflects total drug exposure'}, {'measure': 'Cmax: Maximum Plasma Concentration', 'timeFrame': 'Study Day 0', 'description': 'Cmax is the maximum (or peak) serum concentration of a drug in the body after the drug has been administered'}, {'measure': 'Tmax: Time to Maximum Concentration', 'timeFrame': 'Study Day 0', 'description': 'Tmax is the time it takes a drug to reach the maximum concentration'}, {'measure': 'Ctrough: Trough Level Concentration', 'timeFrame': 'Study Day 14', 'description': 'a trough level or trough concentration (Ctrough) is the concentration reached by a drug immediately before the next dose is administered,'}, {'measure': 'Clearance', 'timeFrame': 'Study Day 0 to 42', 'description': 'Total body clearance of the drug from plasma of MGD014'}, {'measure': 'Vz: Terminal Phase Volume of Distribution of MGD014', 'timeFrame': 'Study Day 1, 2, 7, 14, 21, 28, and 42 (single infusion) and Study Day 1, 3, 14, 28, 42, and 77 (multiple infusions)', 'description': 'The ratio of the total quantity of drug in the body to drug plasma concentration during the elimination'}, {'measure': 'Terminal Half Life of MGD014', 'timeFrame': 'Study Day 0 to Study Day 42', 'description': 'The half-life is the amount of time required for 50% of the drug to be removed from the body'}, {'measure': 'Number of Participants That Developed Antidrug Antibodies to MGD014', 'timeFrame': 'Study Day 1, 14, 28 and 42 (single infusion) and Study Day 1, 14, 28 and 77 (multiple infusions)', 'description': 'Number of participants with antidrug antibodies to MGD014'}, {'measure': 'Number of Participants With Increased Cytokine Levels', 'timeFrame': 'Study Day 1, 2 and 7 (single infusion) and Study Day 1, 3, 14 and 28 (multiple infusions)', 'description': 'Number of participants with increased cytokine levels from baseline after MGD014 administration. This safety measure compares serum cytokine levels obtained prior to dosing with levels obtained after dosing. Increased cytokines can be a measure of T-cell activation in response to MGD014 binding. Cytokines analyzed included interferon-gamma, tumor necrosis factor-alpha, interleukin (IL)2, IL-5, IL-6, and IL-10.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV, Latent HIV-1 infection, HIV therapy, antibody-based therapy'], 'conditions': ['HIV-1-infection']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, open-label single-center study to determine the safety of MGD014 in participants with human immunodeficiency virus (HIV) infection on stable suppressive antiretroviral therapy (ART).', 'detailedDescription': 'Eligible participants will be maintained on ART and receive either one infusion (Part 1) or multiple infusions of MGD014 (Part 2). Part 1 is a single ascending dose study with a 1+3 design for the first 2 dose cohorts, and a 3+3 design with staggered accrual for the 6 higher dose cohorts, with an aim of determining the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of ascending doses up to either the Optimal Biologic Dose (OBD) or the maximum administered dose (MAD).\n\nPart 2 is a multi-dose expansion cohort with MGD014 administered at the OBD, as determined in Part 1. In Part 2, additional assessments on the effects of MGD014 on HIV latent infection parameters will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability and willingness of participant to provide written informed consent.\n* HIV-1 infection, documented by any FDA-approved rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.\n* On a potent, stable, continuous ART regimen for ≥ 24 months prior to Screening.\n* Plasma HIV-1 RNA \\< 50 copies/mL at two time points in the previous 12 months prior to screening (one time point can be screening) and never ≥ 50 copies/mL on 2 consecutive time points in the last 24 months.\n* Adequate organ function based on acceptable laboratory parameters.\n\nExclusion Criteria:\n\n* Women of childbearing potential defined as any female who has experienced menarche and who has not undergone successful surgical sterilization or menopause.\n* History or other evidence of severe illness, immunodeficiency other than HIV, or any other condition that would make the potential participant unsuitable for study.\n* History or other evidence of any condition or process for which signs or symptoms could be confused with reactions to MGD014.\n* History of any HIV immunotherapy or HIV vaccine except for MGD014 within 12 months prior to screening.\n* History of clinically significant cardiovascular disease, severe allergic reactions, malignancy (except non-melanoma skin cancer) within 5 years, seizure disorder within 2 years, organ/tissue transplant, autoimmune disease, unstable asthma, bleeding disorder.\n* Evidence of active viral, or antifungal treatment within 7 days prior to the initiation of study drug\n* Active, asymptomatic, or suspected COVID-19/SARS-CoV-2 infection.\n* Active, untreated syphilis.\n* Use of blood products, cytokine therapy, growth-stimulating factors, cytotoxic chemotherapy or investigational therapy within 90 days.\n* Current use of the antivirals maraviroc and/or enfuvirtide.\n* Any vaccination with exception of flu vaccine within 30 days of screening.'}, 'identificationModule': {'nctId': 'NCT03570918', 'briefTitle': 'MGD014 in HIV-Infected Individuals on Suppressive Antiretroviral Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'MacroGenics'}, 'officialTitle': 'A Phase 1 Study to Evaluate the Safety, Immunologic and Virologic Responses of MGD014 Therapy in HIV-Infected Individuals on Suppressive Antiretroviral Therapy', 'orgStudyIdInfo': {'id': 'CP-MGD014-01'}, 'secondaryIdInfos': [{'id': '272201500032C-2-0-1', 'link': 'https://reporter.nih.gov/quickSearch/272201500032C-2-0-1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MGD014 0.1 micrograms/kilogram (mcg/kg)', 'description': 'a single 2-hour infusion', 'interventionNames': ['Biological: MGD014']}, {'type': 'EXPERIMENTAL', 'label': 'MGD014 0.3 mcg/kg', 'description': 'a single 2-hour infusion', 'interventionNames': ['Biological: MGD014']}, {'type': 'EXPERIMENTAL', 'label': 'MGD014 1.0 mcg/kg', 'description': 'a single 2-hour infusion', 'interventionNames': ['Biological: MGD014']}, {'type': 'EXPERIMENTAL', 'label': 'MGD014 3.0 mcg/kg', 'description': 'a single 2-hour infusion', 'interventionNames': ['Biological: MGD014']}, {'type': 'EXPERIMENTAL', 'label': 'MGD014 10.0 mcg/kg', 'description': 'a single 2-hour infusion', 'interventionNames': ['Biological: MGD014']}, {'type': 'EXPERIMENTAL', 'label': 'MGD014 30.0 mcg/kg', 'description': 'a single 2-hour infusion', 'interventionNames': ['Biological: MGD014']}, {'type': 'EXPERIMENTAL', 'label': 'MGD014 100.0 mcg/kg', 'description': 'a single 2-hour infusion', 'interventionNames': ['Biological: MGD014']}, {'type': 'EXPERIMENTAL', 'label': 'MGD014 300.0 mcg/kg', 'description': 'a single 2-hour infusion', 'interventionNames': ['Biological: MGD014']}, {'type': 'EXPERIMENTAL', 'label': 'MGD014 300.0 mcg/kg multiple doses', 'description': '2-hour infusion every 2 weeks for 3 infusions', 'interventionNames': ['Biological: MGD014']}], 'interventions': [{'name': 'MGD014', 'type': 'BIOLOGICAL', 'description': 'HIV-1 x CD3 bispecific DART molecule', 'armGroupLabels': ['MGD014 0.1 micrograms/kilogram (mcg/kg)', 'MGD014 0.3 mcg/kg', 'MGD014 1.0 mcg/kg', 'MGD014 10.0 mcg/kg', 'MGD014 100.0 mcg/kg', 'MGD014 3.0 mcg/kg', 'MGD014 30.0 mcg/kg', 'MGD014 300.0 mcg/kg', 'MGD014 300.0 mcg/kg multiple doses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Chief Medical Officer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MacroGenics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MacroGenics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}